Re: JAMA: Deaths Associated With Hypocalcemia From Chelation Therapy—Texas, Pennsylvania, and Oregon, 2003-2005

[Guest guest]

These were from IV EDTA.

S S

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So the rumor that the incorrect form of EDTA was used, was not correct in the

Pa case of the death of the 5-year old boy?

[ ] JAMA: Deaths Associated With Hypocalcemia From

Chelation Therapy—Texas, Pennsylvania, and Oregon, 2003-2005

I just got this... http://jama.ama-assn.org/cgi/content/full/295/18/2131

--

Rima Regas

Mom to Leah, age 8 (AS, DSI and APD)

http://www.sensoryintegrationhelp.com

---

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* Deaths Associated With Hypocalcemia From Chelation Therapy—Texas,

Pennsylvania, and Oregon, 2003-2005 *

*JAMA.* 2006;295:2131-2133.

*MMWR. 2006;55:204-207*

Chelating agents bind lead in soft tissues and are used in the treatment of

lead poisoning to enhance urinary and biliary excretion of lead, thus

decreasing total lead levels in the body. 1 During the past 30 years,

environmental and dietary exposures to lead have decreased substantially,

resulting in a considerable decrease in population blood lead levels (BLLs)

2 and a corresponding decrease in the number of patients requiring chelation

therapy. Chelating agents also increase excretion of other heavy metals and

minerals, such as zinc and, in certain cases, calcium. 1 This report

describes three deaths associated with chelation-therapy–related

hypocalcemia

that resulted in cardiac arrest. Several drugs are used in the treatment of

lead poisoning, including edetate disodium calcium (CaEDTA), dimercaperol

(British anti-ite), D-penicillamine, and meso-2,3-dimercaptosuccinic

acid (succimer). Health-care providers who are unfamiliar with chelating

agents and are considering this treatment for lead poisoning should consult

an expert in the chemotherapy of lead poisoning. Hospital pharmacies should

evaluate whether continued stocking of Na 2EDTA is necessary, given the

established risk for hypocalcemia, the availability of less toxic

alternatives, and an ongoing safety review by the Food and Drug

Administration (FDA). Health-care providers and pharmacists should ensure

that Na2EDTA is not administered to children during chelation therapy.

Chelating agents, especially those intended for use in children, should be

effective in reducing lead and other heavy metals from the body without

producing substantial adverse effects on levels of critical serum

electrolytes, such as calcium. The only agent recommended for intravenous

(IV) chelation therapy for children is CaEDTA.1 However, hospital

formularies usually stock multiple chelation agents. One such agent, Na2EDTA,

was formerly used for treatment of hypercalcemia, but its use has become

infrequent because of concerns regarding nephrotoxicity and because of the

availability of less toxic alternatives.3 Furthermore, Na2EDTA contains a

warning stating, " The use of this drug in any particular patient is

recommended only when the severity of the clinical condition justifies the

aggressive measures associated with this type of therapy. " According to the

package insert, Na2EDTA is " indicated in selected patients for the emergency

treatment of hypercalcemia and for the control of ventricular arrhythmias

associated with digitalis toxicity. " According to FDA and CDC, the safety

and effectiveness of Na 2EDTA in pediatric patients has not been

established, and its use is not recommended because it induces hypocalcemia

and possibly fatal tetany.1

In 2005, the Texas Department of Health childhood lead poisoning surveillance

program reported a death attributable to chelation-associated hypocalcemia

to CDC. Subsequently, CDC queried state and local lead-surveillance programs

regarding chelation-related fatalities; additional deaths were identified in

Pennsylvania and Oregon.

*Case Reports*

*Texas*. In February 2005, a girl aged 2 years who was tested for blood lead

during routine health surveillance had a capillary BLL of 47 µg/dL. A venous

BLL of 48 µg/dL obtained 12 days later confirmed the elevated BLL. A

complete blood count and iron study conducted concurrently revealed low

serum iron levels and borderline anemia. On February 28, 2005, the girl was

admitted to a local medical center for combined oral and IV chelation

therapy.

The patient's blood electrolytes at admission were within normal limits.

Initial medication orders included IV Na2EDTA and oral succimer (an agent

primarily used for treatment of lead poisoning). The medication order

subsequently was corrected by the pediatric resident to IV CaEDTA. At 4:00

p.m. on the day of admission, the patient received her first dose of IV

CaEDTA (300 mg in 100 mL normal saline at 25 mL/hr). At 4:35 p.m., she was

administered 200 mg of oral succimer. Her vital signs remained normal

throughout the night. At 4:00 a.m. the next day, a dose of IV Na2EDTA

(instead of IV CaEDTA) was administered. An hour later, the patient's serum

calcium had decreased to 5.2 mg/dL (normal value for pediatric patients:

8.5-10.5 mg/dL). At 7:05 a.m., the child's mother noticed that the child was

limp and not breathing. Bedside procedures did not restore a normal cardiac

rhythm, and a cardiac resuscitation code was called at 7:25 a.m. The child

had no palpable pulse or audible heartbeat. Repeat laboratory values for

serum drawn at 7:55 a.m. indicated that the serum calcium level was <5.0 mg/dL

despite repeated doses of calcium chloride. All attempts at resuscitation

failed, and the girl was pronounced dead at 8:12 a.m.

An autopsy revealed no results of toxicologic significance. A postmortem

radiologic bone survey indicated areas of sclerosis at the metaphyses

(growth arrest and recovery lines compatible with lead exposure). The cause

of death was recorded as sudden cardiac arrest resulting from hypocalcemia

associated with chelation therapy. The hospital's child mortality review

board findings indicated that a dose of IV Na2EDTA was unintentionally

administered to the child.

*Pennsylvania*. In August 2005, a boy aged 5 years with autism died while

receiving IV chelation therapy with Na2EDTA in a physician's office. During

the chelation procedure, the mother noted that the child was limp. The

physician initiated resuscitation, and an emergency services team

transported the child to the hospital. At the emergency department (ED),

further resuscitation was attempted, including administration of at least 1

and possibly 2 doses of IV calcium chloride. Subsequently, the boy's

blood calcium

level was recorded in the ED as 6.9 mg/dL. The child did not regain

consciousness. The coroner examination indicated cause of death as diffuse,

acute cerebral hypoxic-ischemic injury, secondary to diffuse subendocardial

necrosis. The myocardial necrosis resulted from hypocalcemia associated with

administration of Na2EDTA. The case is under investigation by the

Pennsylvania State Board of Medicine.

*Oregon*. In August 2003, a woman aged 53 years with no evidence of coronary

artery disease, intracranial disease, or injury was treated with 700 mg IV

EDTA in a naturopathic practitioner's clinic. The EDTA was provided by a

compounding laboratory (Creative Compounding, ville, Oregon) and was

administered by the practitioner to remove heavy metals from the body. The

practitioner had provided a similar treatment to the patient on three

previous occasions, once in June 2003 and twice in July 2003.

Approximately 10-15

minutes after treatment began, the patient became unconscious. Cardiopulmonary

resuscitation was initiated, and an emergency services team was contacted.

Attempts to revive the patient en route to and in the ED were unsuccessful.

The medical examiner determined the cause of death to be cardiac arrhythmia

resulting from hypocalcemia associated with EDTA infusion and

vascuolar cardiomyopathy.

The patient's ionized calcium level during code was 3.8 mg/dL (normal value

for adult patients: 4.5-5.3 mg/dL) after one IV injection of calcium

gluconate administered by emergency medical technicians en route to the

hospital and another IV injection of calcium chloride in the ED. The Oregon

State Naturopath Licensing Board is conducting an investigation to determine

whether Na2EDTA or CaEDTA was administered to this patient.

The cases described in this report have been reported to FDA. FDA is

performing a safety assessment of Na2EDTA, including a review of the adverse

event reporting system to determine whether other deaths related to use of

chelating agents have been reported.

*Reported by:*

RA Beauchamp, MD, TM Willis, TG Betz, MD, J Villanacci, PhD, Texas Dept of

State Health Svcs. RD Leiker, Oregon Childhood Lead Poisoning Prevention

Program. L Rozin, MD, Allegheny County, Pennsylvania Office of the Coroner.

MJ Brown, ScD, DM Homa, PhD, TA Dignam, MPH, T Morta, Div of Emergency and

Environmental Health Svcs, National Center for Environmental Health, CDC.

*CDC Editorial Note:*

Both children and adults are subject to potentially lethal prescription errors

involving " look-alike, sound-alike " substitutions (i.e., confusion of drugs

with similar names). In a 1-year study of errors in a tertiary care teaching

hospital, 11.4% of medication errors were found to have resulted from use of

the wrong drug name, dosage form, or abbreviation.4 A review of medical

records in the Texas case described in this report revealed that the brand

names for the Na2EDTA product, Endrate® (Hospira, Inc., Lake Forest,

Illinois), and the CaEDTA product, Calcium Disodium Versenate® (3M

Pharmaceuticals, St. , Minnesota), were used interchangeably; this

improper use of drug names likely resulted in the inappropriate

administration of Na2 EDTA.

Although CaEDTA and succimer were ordered for one patient and the form of

EDTA administered to another remains under investigation, these drugs singly

or in combination probably were not responsible for the low calcium levels.

Hypercalcemia as a result of IV administration of CaEDTA has been

reported.5Succimer by itself is

a weak calcium binder but is not associated with a drop in essential

minerals such as calcium.6 Moreover, the reported doses of CaEDTA and

succimer in the Texas case were appropriate and within established safety

limits.

Medical center records and coroner reports indicate that Na2EDTA was

administered in at least two of the cases. Na2EDTA is often part of a

standard hospital formulary; however, it should never be used for treating

lead or other heavy metal poisoning in children because it induces

hypocalcemia, which can lead to tetany and death.7 The error that caused the

death in Texas most likely resulted from miscommunication between the

pharmacy and the pediatric unit.

Chelation therapy with CaEDTA, dimercaperol, or succimer has been the

mainstay of medical management for children with BLLs [image: ≥] 45

µg/dL.1The effectiveness of chelation therapy in improving renal

or nervous system symptoms of chronic mercury toxicity has not been

established. Nonetheless, certain health-care practitioners have used

chelation therapy for autism in the belief that mercury or other heavy

metals are producing the symptoms.8 Other practitioners have recommended

chelation therapy for treatment of coronary artery disease, hoping to

eliminate calcified atherosclerotic plaques that can lead to coronary artery

occlusions and myocardial infarctions. These off-label uses of chelation

therapy are not supported by accepted scientific evidence. The

Institute of Medicine

found no scientific evidence that chelation is an effective therapy for

autism spectrum disorder.8 Because limited consistent data exist on the use

of chelation therapy to treat coronary artery disease, a clinical trial to

assess the safety and effectiveness of chelation therapy is being conducted

by the National Institutes of Health.*

Deaths associated with lead poisoning are rare,9 and childhood deaths caused

by cardiac arrest associated with chelation therapy have not been documented

previously.9 As BLLs among children in the United States continue to

decline,2 fewer children require chelation therapy. Primary care providers

should consult experts in the chemotherapy of lead before using chelation

drug therapy. If such an expert is not available, primary care providers

should contact state or local childhood lead poisoning prevention programs or

the Lead Poisoning Prevention Branch of the National Center for

Environmental Health, CDC.

CDC and its state and local partners will continue to educate health-care

providers and pharmacists to ensure that Na2EDTA is never administered to

children during chelation therapy. CDC recommends that hospital pharmacies

evaluate the need to keep Na2EDTA in their formularies. Case reports of

cardiac arrest or symptoms of hypocalcemia during chelation therapy should be

reported to the CDC Lead Poisoning Prevention Branch (770-488-3300) or to

MedWatch, the FDA adverse event reporting system, at

http://www.fda.gov/medwatch .

*Acknowledgments*

This report is based, in part, on contributions by M Markowitz, MD, Albert

Einstein College of Medicine, New York, New York; SI Fisch, MD, Valley

Baptist Hospital, Harlingen, Texas; and E Strimlan, Allegheny County,

Pennsylvania Office of the Coroner.

*REFERENCES:* 9 available

*Additional information is available at

http://nccam.nih.gov/news/2002/chelation/pressrelease.htm

.

--

Rima Regas

Mom to Leah, age 8 (AS, DSI and APD)

http://www.sensoryintegrationhelp.com

[Guest guest]

This was not a rumor. The doctor used the wrong form of EDTA. His heart stopped

as a result of low calcium.

The coroner examination indicated cause of death as diffuse, acute cerebral

hypoxic-ischemic injury, secondary to diffuse subendocardial necrosis. The

myocardial necrosis resulted from hypocalcemia associated with administration of

Na2EDTA.

A case of a stupid MD not knowing enough chemistry in order to know how to

chelate. EDTA is a dinosaur lead chelator. DMSA is far better, and unlike any

form of EDTA, it will chelate mercury.

[ ] JAMA: Deaths Associated With Hypocalcemia From

Chelation Therapy—Texas, Pennsylvania, and Oregon, 2003-2005

I just got this... http://jama.ama-assn.org/cgi/content/full/295/18/2131

--

Rima Regas

Mom to Leah, age 8 (AS, DSI and APD)

http://www.sensoryintegrationhelp.com

---

From the Centers for Disease Control and Prevention: Morbidity and

Mortality Weekly Report * Article Options* •

Extract<http://jama.ama-assn.org/cgi/content/extract/295/18/2131>

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/content/full/295/18/2131 & title=Deaths+Associated+With+Hypocalcemia+From+Chelati\

on+Therapy--Texas%2C+Pennsylvania%2C+and+Oregon%2C+2003-2005>

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* Deaths Associated With Hypocalcemia From Chelation Therapy—Texas,

Pennsylvania, and Oregon, 2003-2005 *

*JAMA.* 2006;295:2131-2133.

*MMWR. 2006;55:204-207*

Chelating agents bind lead in soft tissues and are used in the treatment of

lead poisoning to enhance urinary and biliary excretion of lead, thus

decreasing total lead levels in the body. 1 During the past 30 years,

environmental and dietary exposures to lead have decreased substantially,

resulting in a considerable decrease in population blood lead levels (BLLs)

2 and a corresponding decrease in the number of patients requiring chelation

therapy. Chelating agents also increase excretion of other heavy metals and

minerals, such as zinc and, in certain cases, calcium. 1 This report

describes three deaths associated with chelation-therapy–related

hypocalcemia

that resulted in cardiac arrest. Several drugs are used in the treatment of

lead poisoning, including edetate disodium calcium (CaEDTA), dimercaperol

(British anti-ite), D-penicillamine, and meso-2,3-dimercaptosuccinic

acid (succimer). Health-care providers who are unfamiliar with chelating

agents and are considering this treatment for lead poisoning should consult

an expert in the chemotherapy of lead poisoning. Hospital pharmacies should

evaluate whether continued stocking of Na 2EDTA is necessary, given the

established risk for hypocalcemia, the availability of less toxic

alternatives, and an ongoing safety review by the Food and Drug

Administration (FDA). Health-care providers and pharmacists should ensure

that Na2EDTA is not administered to children during chelation therapy.

Chelating agents, especially those intended for use in children, should be

effective in reducing lead and other heavy metals from the body without

producing substantial adverse effects on levels of critical serum

electrolytes, such as calcium. The only agent recommended for intravenous

(IV) chelation therapy for children is CaEDTA.1 However, hospital

formularies usually stock multiple chelation agents. One such agent,

Na2EDTA,

was formerly used for treatment of hypercalcemia, but its use has become

infrequent because of concerns regarding nephrotoxicity and because of the

availability of less toxic alternatives.3 Furthermore, Na2EDTA contains a

warning stating, " The use of this drug in any particular patient is

recommended only when the severity of the clinical condition justifies the

aggressive measures associated with this type of therapy. " According to the

package insert, Na2EDTA is " indicated in selected patients for the emergency

treatment of hypercalcemia and for the control of ventricular arrhythmias

associated with digitalis toxicity. " According to FDA and CDC, the safety

and effectiveness of Na 2EDTA in pediatric patients has not been

established, and its use is not recommended because it induces hypocalcemia

and possibly fatal tetany.1

In 2005, the Texas Department of Health childhood lead poisoning

surveillance

program reported a death attributable to chelation-associated hypocalcemia

to CDC. Subsequently, CDC queried state and local lead-surveillance programs

regarding chelation-related fatalities; additional deaths were identified in

Pennsylvania and Oregon.

*Case Reports*

*Texas*. In February 2005, a girl aged 2 years who was tested for blood lead

during routine health surveillance had a capillary BLL of 47 µg/dL. A

venous

BLL of 48 µg/dL obtained 12 days later confirmed the elevated BLL. A

complete blood count and iron study conducted concurrently revealed low

serum iron levels and borderline anemia. On February 28, 2005, the girl was

admitted to a local medical center for combined oral and IV chelation

therapy.

The patient's blood electrolytes at admission were within normal limits.

Initial medication orders included IV Na2EDTA and oral succimer (an agent

primarily used for treatment of lead poisoning). The medication order

subsequently was corrected by the pediatric resident to IV CaEDTA. At 4:00

p.m. on the day of admission, the patient received her first dose of IV

CaEDTA (300 mg in 100 mL normal saline at 25 mL/hr). At 4:35 p.m., she was

administered 200 mg of oral succimer. Her vital signs remained normal

throughout the night. At 4:00 a.m. the next day, a dose of IV Na2EDTA

(instead of IV CaEDTA) was administered. An hour later, the patient's serum

calcium had decreased to 5.2 mg/dL (normal value for pediatric patients:

8.5-10.5 mg/dL). At 7:05 a.m., the child's mother noticed that the child was

limp and not breathing. Bedside procedures did not restore a normal cardiac

rhythm, and a cardiac resuscitation code was called at 7:25 a.m. The child

had no palpable pulse or audible heartbeat. Repeat laboratory values for

serum drawn at 7:55 a.m. indicated that the serum calcium level was <5.0

mg/dL

despite repeated doses of calcium chloride. All attempts at resuscitation

failed, and the girl was pronounced dead at 8:12 a.m.

An autopsy revealed no results of toxicologic significance. A postmortem

radiologic bone survey indicated areas of sclerosis at the metaphyses

(growth arrest and recovery lines compatible with lead exposure). The cause

of death was recorded as sudden cardiac arrest resulting from hypocalcemia

associated with chelation therapy. The hospital's child mortality review

board findings indicated that a dose of IV Na2EDTA was unintentionally

administered to the child.

*Pennsylvania*. In August 2005, a boy aged 5 years with autism died while

receiving IV chelation therapy with Na2EDTA in a physician's office. During

the chelation procedure, the mother noted that the child was limp. The

physician initiated resuscitation, and an emergency services team

transported the child to the hospital. At the emergency department (ED),

further resuscitation was attempted, including administration of at least 1

and possibly 2 doses of IV calcium chloride. Subsequently, the boy's

blood calcium

level was recorded in the ED as 6.9 mg/dL. The child did not regain

consciousness. The coroner examination indicated cause of death as diffuse,

acute cerebral hypoxic-ischemic injury, secondary to diffuse subendocardial

necrosis. The myocardial necrosis resulted from hypocalcemia associated with

administration of Na2EDTA. The case is under investigation by the

Pennsylvania State Board of Medicine.

*Oregon*. In August 2003, a woman aged 53 years with no evidence of coronary

artery disease, intracranial disease, or injury was treated with 700 mg IV

EDTA in a naturopathic practitioner's clinic. The EDTA was provided by a

compounding laboratory (Creative Compounding, ville, Oregon) and was

administered by the practitioner to remove heavy metals from the body. The

practitioner had provided a similar treatment to the patient on three

previous occasions, once in June 2003 and twice in July 2003.

Approximately 10-15

minutes after treatment began, the patient became unconscious.

Cardiopulmonary

resuscitation was initiated, and an emergency services team was contacted.

Attempts to revive the patient en route to and in the ED were unsuccessful.

The medical examiner determined the cause of death to be cardiac arrhythmia

resulting from hypocalcemia associated with EDTA infusion and

vascuolar cardiomyopathy.

The patient's ionized calcium level during code was 3.8 mg/dL (normal value

for adult patients: 4.5-5.3 mg/dL) after one IV injection of calcium

gluconate administered by emergency medical technicians en route to the

hospital and another IV injection of calcium chloride in the ED. The Oregon

State Naturopath Licensing Board is conducting an investigation to determine

whether Na2EDTA or CaEDTA was administered to this patient.

The cases described in this report have been reported to FDA. FDA is

performing a safety assessment of Na2EDTA, including a review of the adverse

event reporting system to determine whether other deaths related to use of

chelating agents have been reported.

*Reported by:*

RA Beauchamp, MD, TM Willis, TG Betz, MD, J Villanacci, PhD, Texas Dept of

State Health Svcs. RD Leiker, Oregon Childhood Lead Poisoning Prevention

Program. L Rozin, MD, Allegheny County, Pennsylvania Office of the Coroner.

MJ Brown, ScD, DM Homa, PhD, TA Dignam, MPH, T Morta, Div of Emergency and

Environmental Health Svcs, National Center for Environmental Health, CDC.

*CDC Editorial Note:*

Both children and adults are subject to potentially lethal prescription

errors

involving " look-alike, sound-alike " substitutions (i.e., confusion of drugs

with similar names). In a 1-year study of errors in a tertiary care teaching

hospital, 11.4% of medication errors were found to have resulted from use of

the wrong drug name, dosage form, or abbreviation.4 A review of medical

records in the Texas case described in this report revealed that the brand

names for the Na2EDTA product, Endrate® (Hospira, Inc., Lake Forest,

Illinois), and the CaEDTA product, Calcium Disodium Versenate® (3M

Pharmaceuticals, St. , Minnesota), were used interchangeably; this

improper use of drug names likely resulted in the inappropriate

administration of Na2 EDTA.

Although CaEDTA and succimer were ordered for one patient and the form of

EDTA administered to another remains under investigation, these drugs singly

or in combination probably were not responsible for the low calcium levels.

Hypercalcemia as a result of IV administration of CaEDTA has been

reported.5Succimer by itself is

a weak calcium binder but is not associated with a drop in essential

minerals such as calcium.6 Moreover, the reported doses of CaEDTA and

succimer in the Texas case were appropriate and within established safety

limits.

Medical center records and coroner reports indicate that Na2EDTA was

administered in at least two of the cases. Na2EDTA is often part of a

standard hospital formulary; however, it should never be used for treating

lead or other heavy metal poisoning in children because it induces

hypocalcemia, which can lead to tetany and death.7 The error that caused the

death in Texas most likely resulted from miscommunication between the

pharmacy and the pediatric unit.

Chelation therapy with CaEDTA, dimercaperol, or succimer has been the

mainstay of medical management for children with BLLs [image: ≥] 45

µg/dL.1The effectiveness of chelation therapy in improving renal

or nervous system symptoms of chronic mercury toxicity has not been

established. Nonetheless, certain health-care practitioners have used

chelation therapy for autism in the belief that mercury or other heavy

metals are producing the symptoms.8 Other practitioners have recommended

chelation therapy for treatment of coronary artery disease, hoping to

eliminate calcified atherosclerotic plaques that can lead to coronary artery

occlusions and myocardial infarctions. These off-label uses of chelation

therapy are not supported by accepted scientific evidence. The

Institute of Medicine

found no scientific evidence that chelation is an effective therapy for

autism spectrum disorder.8 Because limited consistent data exist on the use

of chelation therapy to treat coronary artery disease, a clinical trial to

assess the safety and effectiveness of chelation therapy is being conducted

by the National Institutes of Health.*

Deaths associated with lead poisoning are rare,9 and childhood deaths caused

by cardiac arrest associated with chelation therapy have not been documented

previously.9 As BLLs among children in the United States continue to

decline,2 fewer children require chelation therapy. Primary care providers

should consult experts in the chemotherapy of lead before using chelation

drug therapy. If such an expert is not available, primary care providers

should contact state or local childhood lead poisoning prevention programs

or

the Lead Poisoning Prevention Branch of the National Center for

Environmental Health, CDC.

CDC and its state and local partners will continue to educate health-care

providers and pharmacists to ensure that Na2EDTA is never administered to

children during chelation therapy. CDC recommends that hospital pharmacies

evaluate the need to keep Na2EDTA in their formularies. Case reports of

cardiac arrest or symptoms of hypocalcemia during chelation therapy should

be

reported to the CDC Lead Poisoning Prevention Branch (770-488-3300) or to

MedWatch, the FDA adverse event reporting system, at

http://www.fda.gov/medwatch .

*Acknowledgments*

This report is based, in part, on contributions by M Markowitz, MD, Albert

Einstein College of Medicine, New York, New York; SI Fisch, MD, Valley

Baptist Hospital, Harlingen, Texas; and E Strimlan, Allegheny County,

Pennsylvania Office of the Coroner.

*REFERENCES:* 9 available

*Additional information is available at

http://nccam.nih.gov/news/2002/chelation/pressrelease.htm

.

--

Rima Regas

Mom to Leah, age 8 (AS, DSI and APD)

http://www.sensoryintegrationhelp.com

[Guest guest]

More specifically, the deaths were from disodium EDTA (also called

Endrate). This is not the type of EDTA used with autistic kids or

those with lead poisoning, which is calcium disodium EDTA (or calcium

disodium Versenate).

>

>

> These were from IV EDTA.

> S S

>

>

>

>

> _______________________________________________

> Join Excite! - http://www.excite.com

> The most personalized portal on the Web!

>

[Guest guest]

What is the basis for your claim that DMSA is better for lead

removal than EDTA? That seems to fly in the face of the experience

of almost everyone I've talked to that has tried both (including

myself) in terms of both clinincal results and labs tests. In terms

of safety, both are approved for use in pediatric populations.

Also, why do you think that CaNa2EDTA does not pull mercury? Again,

that is inconsistent with my experience and the experience of those

who use use this product a lot.

I'm not defending the doctor, but it's pretty clear that this was a

drug error not an intentional use of Na2EDTA.

Darren

>

> This was not a rumor. The doctor used the wrong form of EDTA. His

heart stopped as a result of low calcium.

>

> The coroner examination indicated cause of death as diffuse, acute

cerebral hypoxic-ischemic injury, secondary to diffuse

subendocardial necrosis. The myocardial necrosis resulted from

hypocalcemia associated with administration of Na2EDTA.

>

> A case of a stupid MD not knowing enough chemistry in order to

know how to chelate. EDTA is a dinosaur lead chelator. DMSA is far

better, and unlike any form of EDTA, it will chelate mercury.

> [ ] JAMA: Deaths Associated With

Hypocalcemia From Chelation Therapy†" Texas, Pennsylvania, and

Oregon, 2003-2005

>

>

> I just got this... http://jama.ama-

assn.org/cgi/content/full/295/18/2131

>

> --

> Rima Regas

> Mom to Leah, age 8 (AS, DSI and APD)

> http://www.sensoryintegrationhelp.com

>

> ---

>

> From the Centers for Disease Control and Prevention: Morbidity

and

> Mortality Weekly Report * Article Options* •

> Extract<http://jama.ama-

assn.org/cgi/content/extract/295/18/2131>

> • PDF <http://jama.ama-assn.org/cgi/reprint/295/18/2131>

• Send to a

> Friend<http://jama.ama-assn.org/cgi/mailafriend?

url=http://jama.ama-

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pocalcemia+From+Chelation+Therapy--Texas%2C+Pennsylvania%

2C+and+Oregon%2C+2003-2005>

> • Similar articles in this

> journal<http://jama.ama-assn.org/cgi/search?

qbe=jama;295/18/2131 & journalcode=jama & minscore=50>

> * Literature Track* • Add to File

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> * Topic Collections* • Occupational and Environmental

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> • Topic Collection Alerts <http://jama.ama-

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> * Deaths Associated With Hypocalcemia From Chelation

Therapy†" Texas,

> Pennsylvania, and Oregon, 2003-2005 *

>

> *JAMA.* 2006;295:2131-2133.

>

> *MMWR. 2006;55:204-207*

>

> Chelating agents bind lead in soft tissues and are used in the

treatment of

> lead poisoning to enhance urinary and biliary excretion of

lead, thus

> decreasing total lead levels in the body. 1 During the past 30

years,

> environmental and dietary exposures to lead have decreased

substantially,

> resulting in a considerable decrease in population blood lead

levels (BLLs)

> 2 and a corresponding decrease in the number of patients

requiring chelation

> therapy. Chelating agents also increase excretion of other

heavy metals and

> minerals, such as zinc and, in certain cases, calcium. 1 This

report

> describes three deaths associated with chelation-

therapy†" related hypocalcemia

> that resulted in cardiac arrest. Several drugs are used in the

treatment of

> lead poisoning, including edetate disodium calcium (CaEDTA),

dimercaperol

> (British anti-ite), D-penicillamine, and meso-2,3-

dimercaptosuccinic

> acid (succimer). Health-care providers who are unfamiliar with

chelating

> agents and are considering this treatment for lead poisoning

should consult

> an expert in the chemotherapy of lead poisoning. Hospital

pharmacies should

> evaluate whether continued stocking of Na 2EDTA is necessary,

given the

> established risk for hypocalcemia, the availability of less

toxic

> alternatives, and an ongoing safety review by the Food and Drug

> Administration (FDA). Health-care providers and pharmacists

should ensure

> that Na2EDTA is not administered to children during chelation

therapy.

>

> Chelating agents, especially those intended for use in

children, should be

> effective in reducing lead and other heavy metals from the

body without

> producing substantial adverse effects on levels of critical

serum

> electrolytes, such as calcium. The only agent recommended for

intravenous

> (IV) chelation therapy for children is CaEDTA.1 However,

hospital

> formularies usually stock multiple chelation agents. One such

agent, Na2EDTA,

> was formerly used for treatment of hypercalcemia, but its use

has become

> infrequent because of concerns regarding nephrotoxicity and

because of the

> availability of less toxic alternatives.3 Furthermore, Na2EDTA

contains a

> warning stating, " The use of this drug in any particular

patient is

> recommended only when the severity of the clinical condition

justifies the

> aggressive measures associated with this type of therapy. "

According to the

> package insert, Na2EDTA is " indicated in selected patients for

the emergency

> treatment of hypercalcemia and for the control of ventricular

arrhythmias

> associated with digitalis toxicity. " According to FDA and CDC,

the safety

> and effectiveness of Na 2EDTA in pediatric patients has not

been

> established, and its use is not recommended because it induces

hypocalcemia

> and possibly fatal tetany.1

>

> In 2005, the Texas Department of Health childhood lead

poisoning surveillance

> program reported a death attributable to chelation-associated

hypocalcemia

> to CDC. Subsequently, CDC queried state and local lead-

surveillance programs

> regarding chelation-related fatalities; additional deaths were

identified in

> Pennsylvania and Oregon.

>

> *Case Reports*

> *Texas*. In February 2005, a girl aged 2 years who was tested

for blood lead

> during routine health surveillance had a capillary BLL of 47

µg/dL. A venous

> BLL of 48 µg/dL obtained 12 days later confirmed the elevated

BLL. A

> complete blood count and iron study conducted concurrently

revealed low

> serum iron levels and borderline anemia. On February 28, 2005,

the girl was

> admitted to a local medical center for combined oral and IV

chelation

> therapy.

>

> The patient's blood electrolytes at admission were within

normal limits.

> Initial medication orders included IV Na2EDTA and oral

succimer (an agent

> primarily used for treatment of lead poisoning). The

medication order

> subsequently was corrected by the pediatric resident to IV

CaEDTA. At 4:00

> p.m. on the day of admission, the patient received her first

dose of IV

> CaEDTA (300 mg in 100 mL normal saline at 25 mL/hr). At 4:35

p.m., she was

> administered 200 mg of oral succimer. Her vital signs remained

normal

> throughout the night. At 4:00 a.m. the next day, a dose of IV

Na2EDTA

> (instead of IV CaEDTA) was administered. An hour later, the

patient's serum

> calcium had decreased to 5.2 mg/dL (normal value for pediatric

patients:

> 8.5-10.5 mg/dL). At 7:05 a.m., the child's mother noticed that

the child was

> limp and not breathing. Bedside procedures did not restore a

normal cardiac

> rhythm, and a cardiac resuscitation code was called at 7:25

a.m. The child

> had no palpable pulse or audible heartbeat. Repeat laboratory

values for

> serum drawn at 7:55 a.m. indicated that the serum calcium

level was <5.0 mg/dL

> despite repeated doses of calcium chloride. All attempts at

resuscitation

> failed, and the girl was pronounced dead at 8:12 a.m.

>

> An autopsy revealed no results of toxicologic significance. A

postmortem

> radiologic bone survey indicated areas of sclerosis at the

metaphyses

> (growth arrest and recovery lines compatible with lead

exposure). The cause

> of death was recorded as sudden cardiac arrest resulting from

hypocalcemia

> associated with chelation therapy. The hospital's child

mortality review

> board findings indicated that a dose of IV Na2EDTA was

unintentionally

> administered to the child.

>

> *Pennsylvania*. In August 2005, a boy aged 5 years with autism

died while

> receiving IV chelation therapy with Na2EDTA in a physician's

office. During

> the chelation procedure, the mother noted that the child was

limp. The

> physician initiated resuscitation, and an emergency services

team

> transported the child to the hospital. At the emergency

department (ED),

> further resuscitation was attempted, including administration

of at least 1

> and possibly 2 doses of IV calcium chloride. Subsequently, the

boy's

> blood calcium

> level was recorded in the ED as 6.9 mg/dL. The child did not

regain

> consciousness. The coroner examination indicated cause of

death as diffuse,

> acute cerebral hypoxic-ischemic injury, secondary to diffuse

subendocardial

> necrosis. The myocardial necrosis resulted from hypocalcemia

associated with

> administration of Na2EDTA. The case is under investigation by

the

> Pennsylvania State Board of Medicine.

>

> *Oregon*. In August 2003, a woman aged 53 years with no

evidence of coronary

> artery disease, intracranial disease, or injury was treated

with 700 mg IV

> EDTA in a naturopathic practitioner's clinic. The EDTA was

provided by a

> compounding laboratory (Creative Compounding, ville,

Oregon) and was

> administered by the practitioner to remove heavy metals from

the body. The

> practitioner had provided a similar treatment to the patient

on three

> previous occasions, once in June 2003 and twice in July 2003.

> Approximately 10-15

> minutes after treatment began, the patient became unconscious.

Cardiopulmonary

> resuscitation was initiated, and an emergency services team

was contacted.

> Attempts to revive the patient en route to and in the ED were

unsuccessful.

> The medical examiner determined the cause of death to be

cardiac arrhythmia

> resulting from hypocalcemia associated with EDTA infusion and

> vascuolar cardiomyopathy.

> The patient's ionized calcium level during code was 3.8 mg/dL

(normal value

> for adult patients: 4.5-5.3 mg/dL) after one IV injection of

calcium

> gluconate administered by emergency medical technicians en

route to the

> hospital and another IV injection of calcium chloride in the

ED. The Oregon

> State Naturopath Licensing Board is conducting an

investigation to determine

> whether Na2EDTA or CaEDTA was administered to this patient.

>

> The cases described in this report have been reported to FDA.

FDA is

> performing a safety assessment of Na2EDTA, including a review

of the adverse

> event reporting system to determine whether other deaths

related to use of

> chelating agents have been reported.

>

>

> *Reported by:*

> RA Beauchamp, MD, TM Willis, TG Betz, MD, J Villanacci, PhD,

Texas Dept of

> State Health Svcs. RD Leiker, Oregon Childhood Lead Poisoning

Prevention

> Program. L Rozin, MD, Allegheny County, Pennsylvania Office of

the Coroner.

> MJ Brown, ScD, DM Homa, PhD, TA Dignam, MPH, T Morta, Div of

Emergency and

> Environmental Health Svcs, National Center for Environmental

Health, CDC.

>

>

> *CDC Editorial Note:*

> Both children and adults are subject to potentially lethal

prescription errors

> involving " look-alike, sound-alike " substitutions (i.e.,

confusion of drugs

> with similar names). In a 1-year study of errors in a tertiary

care teaching

> hospital, 11.4% of medication errors were found to have

resulted from use of

> the wrong drug name, dosage form, or abbreviation.4 A review

of medical

> records in the Texas case described in this report revealed

that the brand

> names for the Na2EDTA product, Endrate® (Hospira, Inc., Lake

Forest,

> Illinois), and the CaEDTA product, Calcium Disodium Versenate

® (3M

> Pharmaceuticals, St. , Minnesota), were used

interchangeably; this

> improper use of drug names likely resulted in the inappropriate

> administration of Na2 EDTA.

>

> Although CaEDTA and succimer were ordered for one patient and

the form of

> EDTA administered to another remains under investigation,

these drugs singly

> or in combination probably were not responsible for the low

calcium levels.

> Hypercalcemia as a result of IV administration of CaEDTA has

been

> reported.5Succimer by itself is

> a weak calcium binder but is not associated with a drop in

essential

> minerals such as calcium.6 Moreover, the reported doses of

CaEDTA and

> succimer in the Texas case were appropriate and within

established safety

> limits.

>

> Medical center records and coroner reports indicate that

Na2EDTA was

> administered in at least two of the cases. Na2EDTA is often

part of a

> standard hospital formulary; however, it should never be used

for treating

> lead or other heavy metal poisoning in children because it

induces

> hypocalcemia, which can lead to tetany and death.7 The error

that caused the

> death in Texas most likely resulted from miscommunication

between the

> pharmacy and the pediatric unit.

>

> Chelation therapy with CaEDTA, dimercaperol, or succimer has

been the

> mainstay of medical management for children with BLLs [image:

≥] 45

> µg/dL.1The effectiveness of chelation therapy in improving

renal

> or nervous system symptoms of chronic mercury toxicity has not

been

> established. Nonetheless, certain health-care practitioners

have used

> chelation therapy for autism in the belief that mercury or

other heavy

> metals are producing the symptoms.8 Other practitioners have

recommended

> chelation therapy for treatment of coronary artery disease,

hoping to

> eliminate calcified atherosclerotic plaques that can lead to

coronary artery

> occlusions and myocardial infarctions. These off-label uses of

chelation

> therapy are not supported by accepted scientific evidence. The

> Institute of Medicine

> found no scientific evidence that chelation is an effective

therapy for

> autism spectrum disorder.8 Because limited consistent data

exist on the use

> of chelation therapy to treat coronary artery disease, a

clinical trial to

> assess the safety and effectiveness of chelation therapy is

being conducted

> by the National Institutes of Health.*

>

> Deaths associated with lead poisoning are rare,9 and childhood

deaths caused

> by cardiac arrest associated with chelation therapy have not

been documented

> previously.9 As BLLs among children in the United States

continue to

> decline,2 fewer children require chelation therapy. Primary

care providers

> should consult experts in the chemotherapy of lead before

using chelation

> drug therapy. If such an expert is not available, primary care

providers

> should contact state or local childhood lead poisoning

prevention programs or

> the Lead Poisoning Prevention Branch of the National Center for

> Environmental Health, CDC.

>

> CDC and its state and local partners will continue to educate

health-care

> providers and pharmacists to ensure that Na2EDTA is never

administered to

> children during chelation therapy. CDC recommends that

hospital pharmacies

> evaluate the need to keep Na2EDTA in their formularies. Case

reports of

> cardiac arrest or symptoms of hypocalcemia during chelation

therapy should be

> reported to the CDC Lead Poisoning Prevention Branch (770-488-

3300) or to

> MedWatch, the FDA adverse event reporting system, at

> http://www.fda.gov/medwatch .

>

>

> *Acknowledgments*

> This report is based, in part, on contributions by M

Markowitz, MD, Albert

> Einstein College of Medicine, New York, New York; SI Fisch,

MD, Valley

> Baptist Hospital, Harlingen, Texas; and E Strimlan, Allegheny

County,

> Pennsylvania Office of the Coroner.

>

> *REFERENCES:* 9 available

>

> *Additional information is available at

> http://nccam.nih.gov/news/2002/chelation/pressrelease.htm

> .

>

>

>

>

>

>

> --

> Rima Regas

> Mom to Leah, age 8 (AS, DSI and APD)

> http://www.sensoryintegrationhelp.com

>

>

>

[Guest guest]

I dont know about lead, but from what I understand and have read

EDTA alone cannot remove toxic metals that have bonded to cells

particularly in the brain, wheras DSMA can. EDTA may work just fine

on PB though, I was only reading about HG. The use of both chelators

together is supposed to be more effective, but that seems like it

has more potential for causing iron or other defficiencies.

Didnt mean to chime in on your string, I was just doing some

reading.

> >

> > This was not a rumor. The doctor used the wrong form of EDTA.

His

> heart stopped as a result of low calcium.

> >

> > The coroner examination indicated cause of death as diffuse,

acute

> cerebral hypoxic-ischemic injury, secondary to diffuse

> subendocardial necrosis. The myocardial necrosis resulted from

> hypocalcemia associated with administration of Na2EDTA.

> >

> > A case of a stupid MD not knowing enough chemistry in order to

> know how to chelate. EDTA is a dinosaur lead chelator. DMSA is far

> better, and unlike any form of EDTA, it will chelate mercury.

> > [ ] JAMA: Deaths Associated With

> Hypocalcemia From Chelation Therapy†" Texas, Pennsylvania, and

> Oregon, 2003-2005

> >

> >

> > I just got this... http://jama.ama-

> assn.org/cgi/content/full/295/18/2131

> >

> > --

> > Rima Regas

> > Mom to Leah, age 8 (AS, DSI and APD)

> > http://www.sensoryintegrationhelp.com

> >

> > ---

> >

> > From the Centers for Disease Control and Prevention:

Morbidity

> and

> > Mortality Weekly Report * Article Options* •

> > Extract<http://jama.ama-

> assn.org/cgi/content/extract/295/18/2131>

> > • PDF <http://jama.ama-assn.org/cgi/reprint/295/18/2131>

> • Send to a

> > Friend<http://jama.ama-assn.org/cgi/mailafriend?

> url=http://jama.ama-

>

assn.org/cgi/content/full/295/18/2131 & title=Deaths+Associated+With+Hy

> pocalcemia+From+Chelation+Therapy--Texas%2C+Pennsylvania%

> 2C+and+Oregon%2C+2003-2005>

> > • Similar articles in this

> > journal<http://jama.ama-assn.org/cgi/search?

> qbe=jama;295/18/2131 & journalcode=jama & minscore=50>

> > * Literature Track* • Add to File

> > Drawer<http://jama.ama-assn.org/cgi/folders?

> action=addtofolder & wherefrom=JOURNALS & wrapped_id=jama;295/18/2131>

> > • Download to Citation

> > Manager<http://jama.ama-assn.org/cgi/citmgr?

> gca=jama;295/18/2131>

> > • Contact me when this article is

> > cited<http://jama.ama-assn.org/cgi/alerts/ctalert?

>

alertType=citedby & addAlert=cited_by & saveAlert=no & cited_by_criteria_re

> sid=jama;295/18/2131 & return_type=article & return_url=%2Fcgi%

2Fcontent%

> 2Ffull%2F295%2F18%2F2131>

> > * Topic Collections* • Occupational and Environmental

> > Medicine<http://jama.ama-

> assn.org/cgi/collection/occupational_and_environmental_medicine>

> > • Adverse Effects <http://jama.ama-

> assn.org/cgi/collection/adverse_effects>

> > • Topic Collection Alerts <http://jama.ama-

> assn.org/cgi/alerts/collalert>

> > * Deaths Associated With Hypocalcemia From Chelation

> Therapy†" Texas,

> > Pennsylvania, and Oregon, 2003-2005 *

> >

> > *JAMA.* 2006;295:2131-2133.

> >

> > *MMWR. 2006;55:204-207*

> >

> > Chelating agents bind lead in soft tissues and are used in

the

> treatment of

> > lead poisoning to enhance urinary and biliary excretion of

> lead, thus

> > decreasing total lead levels in the body. 1 During the past

30

> years,

> > environmental and dietary exposures to lead have decreased

> substantially,

> > resulting in a considerable decrease in population blood

lead

> levels (BLLs)

> > 2 and a corresponding decrease in the number of patients

> requiring chelation

> > therapy. Chelating agents also increase excretion of other

> heavy metals and

> > minerals, such as zinc and, in certain cases, calcium. 1

This

> report

> > describes three deaths associated with chelation-

> therapy†" related hypocalcemia

> > that resulted in cardiac arrest. Several drugs are used in

the

> treatment of

> > lead poisoning, including edetate disodium calcium (CaEDTA),

> dimercaperol

> > (British anti-ite), D-penicillamine, and meso-2,3-

> dimercaptosuccinic

> > acid (succimer). Health-care providers who are unfamiliar

with

> chelating

> > agents and are considering this treatment for lead poisoning

> should consult

> > an expert in the chemotherapy of lead poisoning. Hospital

> pharmacies should

> > evaluate whether continued stocking of Na 2EDTA is

necessary,

> given the

> > established risk for hypocalcemia, the availability of less

> toxic

> > alternatives, and an ongoing safety review by the Food and

Drug

> > Administration (FDA). Health-care providers and pharmacists

> should ensure

> > that Na2EDTA is not administered to children during

chelation

> therapy.

> >

> > Chelating agents, especially those intended for use in

> children, should be

> > effective in reducing lead and other heavy metals from the

> body without

> > producing substantial adverse effects on levels of critical

> serum

> > electrolytes, such as calcium. The only agent recommended

for

> intravenous

> > (IV) chelation therapy for children is CaEDTA.1 However,

> hospital

> > formularies usually stock multiple chelation agents. One

such

> agent, Na2EDTA,

> > was formerly used for treatment of hypercalcemia, but its

use

> has become

> > infrequent because of concerns regarding nephrotoxicity and

> because of the

> > availability of less toxic alternatives.3 Furthermore,

Na2EDTA

> contains a

> > warning stating, " The use of this drug in any particular

> patient is

> > recommended only when the severity of the clinical condition

> justifies the

> > aggressive measures associated with this type of therapy. "

> According to the

> > package insert, Na2EDTA is " indicated in selected patients

for

> the emergency

> > treatment of hypercalcemia and for the control of

ventricular

> arrhythmias

> > associated with digitalis toxicity. " According to FDA and

CDC,

> the safety

> > and effectiveness of Na 2EDTA in pediatric patients has not

> been

> > established, and its use is not recommended because it

induces

> hypocalcemia

> > and possibly fatal tetany.1

> >

> > In 2005, the Texas Department of Health childhood lead

> poisoning surveillance

> > program reported a death attributable to chelation-

associated

> hypocalcemia

> > to CDC. Subsequently, CDC queried state and local lead-

> surveillance programs

> > regarding chelation-related fatalities; additional deaths

were

> identified in

> > Pennsylvania and Oregon.

> >

> > *Case Reports*

> > *Texas*. In February 2005, a girl aged 2 years who was

tested

> for blood lead

> > during routine health surveillance had a capillary BLL of 47

> µg/dL. A venous

> > BLL of 48 µg/dL obtained 12 days later confirmed the

elevated

> BLL. A

> > complete blood count and iron study conducted concurrently

> revealed low

> > serum iron levels and borderline anemia. On February 28,

2005,

> the girl was

> > admitted to a local medical center for combined oral and IV

> chelation

> > therapy.

> >

> > The patient's blood electrolytes at admission were within

> normal limits.

> > Initial medication orders included IV Na2EDTA and oral

> succimer (an agent

> > primarily used for treatment of lead poisoning). The

> medication order

> > subsequently was corrected by the pediatric resident to IV

> CaEDTA. At 4:00

> > p.m. on the day of admission, the patient received her first

> dose of IV

> > CaEDTA (300 mg in 100 mL normal saline at 25 mL/hr). At 4:35

> p.m., she was

> > administered 200 mg of oral succimer. Her vital signs

remained

> normal

> > throughout the night. At 4:00 a.m. the next day, a dose of

IV

> Na2EDTA

> > (instead of IV CaEDTA) was administered. An hour later, the

> patient's serum

> > calcium had decreased to 5.2 mg/dL (normal value for

pediatric

> patients:

> > 8.5-10.5 mg/dL). At 7:05 a.m., the child's mother noticed

that

> the child was

> > limp and not breathing. Bedside procedures did not restore a

> normal cardiac

> > rhythm, and a cardiac resuscitation code was called at 7:25

> a.m. The child

> > had no palpable pulse or audible heartbeat. Repeat

laboratory

> values for

> > serum drawn at 7:55 a.m. indicated that the serum calcium

> level was <5.0 mg/dL

> > despite repeated doses of calcium chloride. All attempts at

> resuscitation

> > failed, and the girl was pronounced dead at 8:12 a.m.

> >

> > An autopsy revealed no results of toxicologic significance.

A

> postmortem

> > radiologic bone survey indicated areas of sclerosis at the

> metaphyses

> > (growth arrest and recovery lines compatible with lead

> exposure). The cause

> > of death was recorded as sudden cardiac arrest resulting

from

> hypocalcemia

> > associated with chelation therapy. The hospital's child

> mortality review

> > board findings indicated that a dose of IV Na2EDTA was

> unintentionally

> > administered to the child.

> >

> > *Pennsylvania*. In August 2005, a boy aged 5 years with

autism

> died while

> > receiving IV chelation therapy with Na2EDTA in a physician's

> office. During

> > the chelation procedure, the mother noted that the child was

> limp. The

> > physician initiated resuscitation, and an emergency services

> team

> > transported the child to the hospital. At the emergency

> department (ED),

> > further resuscitation was attempted, including

administration

> of at least 1

> > and possibly 2 doses of IV calcium chloride. Subsequently,

the

> boy's

> > blood calcium

> > level was recorded in the ED as 6.9 mg/dL. The child did not

> regain

> > consciousness. The coroner examination indicated cause of

> death as diffuse,

> > acute cerebral hypoxic-ischemic injury, secondary to diffuse

> subendocardial

> > necrosis. The myocardial necrosis resulted from hypocalcemia

> associated with

> > administration of Na2EDTA. The case is under investigation

by

> the

> > Pennsylvania State Board of Medicine.

> >

> > *Oregon*. In August 2003, a woman aged 53 years with no

> evidence of coronary

> > artery disease, intracranial disease, or injury was treated

> with 700 mg IV

> > EDTA in a naturopathic practitioner's clinic. The EDTA was

> provided by a

> > compounding laboratory (Creative Compounding, ville,

> Oregon) and was

> > administered by the practitioner to remove heavy metals from

> the body. The

> > practitioner had provided a similar treatment to the patient

> on three

> > previous occasions, once in June 2003 and twice in July 2003.

> > Approximately 10-15

> > minutes after treatment began, the patient became

unconscious.

> Cardiopulmonary

> > resuscitation was initiated, and an emergency services team

> was contacted.

> > Attempts to revive the patient en route to and in the ED

were

> unsuccessful.

> > The medical examiner determined the cause of death to be

> cardiac arrhythmia

> > resulting from hypocalcemia associated with EDTA infusion and

> > vascuolar cardiomyopathy.

> > The patient's ionized calcium level during code was 3.8

mg/dL

> (normal value

> > for adult patients: 4.5-5.3 mg/dL) after one IV injection of

> calcium

> > gluconate administered by emergency medical technicians en

> route to the

> > hospital and another IV injection of calcium chloride in the

> ED. The Oregon

> > State Naturopath Licensing Board is conducting an

> investigation to determine

> > whether Na2EDTA or CaEDTA was administered to this patient.

> >

> > The cases described in this report have been reported to

FDA.

> FDA is

> > performing a safety assessment of Na2EDTA, including a

review

> of the adverse

> > event reporting system to determine whether other deaths

> related to use of

> > chelating agents have been reported.

> >

> >

> > *Reported by:*

> > RA Beauchamp, MD, TM Willis, TG Betz, MD, J Villanacci, PhD,

> Texas Dept of

> > State Health Svcs. RD Leiker, Oregon Childhood Lead

Poisoning

> Prevention

> > Program. L Rozin, MD, Allegheny County, Pennsylvania Office

of

> the Coroner.

> > MJ Brown, ScD, DM Homa, PhD, TA Dignam, MPH, T Morta, Div of

> Emergency and

> > Environmental Health Svcs, National Center for Environmental

> Health, CDC.

> >

> >

> > *CDC Editorial Note:*

> > Both children and adults are subject to potentially lethal

> prescription errors

> > involving " look-alike, sound-alike " substitutions (i.e.,

> confusion of drugs

> > with similar names). In a 1-year study of errors in a

tertiary

> care teaching

> > hospital, 11.4% of medication errors were found to have

> resulted from use of

> > the wrong drug name, dosage form, or abbreviation.4 A review

> of medical

> > records in the Texas case described in this report revealed

> that the brand

> > names for the Na2EDTA product, Endrate® (Hospira, Inc.,

Lake

> Forest,

> > Illinois), and the CaEDTA product, Calcium Disodium Versenate

> ® (3M

> > Pharmaceuticals, St. , Minnesota), were used

> interchangeably; this

> > improper use of drug names likely resulted in the

inappropriate

> > administration of Na2 EDTA.

> >

> > Although CaEDTA and succimer were ordered for one patient

and

> the form of

> > EDTA administered to another remains under investigation,

> these drugs singly

> > or in combination probably were not responsible for the low

> calcium levels.

> > Hypercalcemia as a result of IV administration of CaEDTA has

> been

> > reported.5Succimer by itself is

> > a weak calcium binder but is not associated with a drop in

> essential

> > minerals such as calcium.6 Moreover, the reported doses of

> CaEDTA and

> > succimer in the Texas case were appropriate and within

> established safety

> > limits.

> >

> > Medical center records and coroner reports indicate that

> Na2EDTA was

> > administered in at least two of the cases. Na2EDTA is often

> part of a

> > standard hospital formulary; however, it should never be

used

> for treating

> > lead or other heavy metal poisoning in children because it

> induces

> > hypocalcemia, which can lead to tetany and death.7 The error

> that caused the

> > death in Texas most likely resulted from miscommunication

> between the

> > pharmacy and the pediatric unit.

> >

> > Chelation therapy with CaEDTA, dimercaperol, or succimer has

> been the

> > mainstay of medical management for children with BLLs

[image:

> ≥] 45

> > µg/dL.1The effectiveness of chelation therapy in improving

> renal

> > or nervous system symptoms of chronic mercury toxicity has

not

> been

> > established. Nonetheless, certain health-care practitioners

> have used

> > chelation therapy for autism in the belief that mercury or

> other heavy

> > metals are producing the symptoms.8 Other practitioners have

> recommended

> > chelation therapy for treatment of coronary artery disease,

> hoping to

> > eliminate calcified atherosclerotic plaques that can lead to

> coronary artery

> > occlusions and myocardial infarctions. These off-label uses

of

> chelation

> > therapy are not supported by accepted scientific evidence.

The

> > Institute of Medicine

> > found no scientific evidence that chelation is an effective

> therapy for

> > autism spectrum disorder.8 Because limited consistent data

> exist on the use

> > of chelation therapy to treat coronary artery disease, a

> clinical trial to

> > assess the safety and effectiveness of chelation therapy is

> being conducted

> > by the National Institutes of Health.*

> >

> > Deaths associated with lead poisoning are rare,9 and

childhood

> deaths caused

> > by cardiac arrest associated with chelation therapy have not

> been documented

> > previously.9 As BLLs among children in the United States

> continue to

> > decline,2 fewer children require chelation therapy. Primary

> care providers

> > should consult experts in the chemotherapy of lead before

> using chelation

> > drug therapy. If such an expert is not available, primary

care

> providers

> > should contact state or local childhood lead poisoning

> prevention programs or

> > the Lead Poisoning Prevention Branch of the National Center

for

> > Environmental Health, CDC.

> >

> > CDC and its state and local partners will continue to

educate

> health-care

> > providers and pharmacists to ensure that Na2EDTA is never

> administered to

> > children during chelation therapy. CDC recommends that

> hospital pharmacies

> > evaluate the need to keep Na2EDTA in their formularies. Case

> reports of

> > cardiac arrest or symptoms of hypocalcemia during chelation

> therapy should be

> > reported to the CDC Lead Poisoning Prevention Branch (770-

488-

> 3300) or to

> > MedWatch, the FDA adverse event reporting system, at

> > http://www.fda.gov/medwatch .

> >

> >

> > *Acknowledgments*

> > This report is based, in part, on contributions by M

> Markowitz, MD, Albert

> > Einstein College of Medicine, New York, New York; SI Fisch,

> MD, Valley

> > Baptist Hospital, Harlingen, Texas; and E Strimlan,

Allegheny

> County,

> > Pennsylvania Office of the Coroner.

> >

> > *REFERENCES:* 9 available

> >

> > *Additional information is available at

> > http://nccam.nih.gov/news/2002/chelation/pressrelease.htm

> > .

> >

> >

> >

> >

> >

> >

> > --

> > Rima Regas

> > Mom to Leah, age 8 (AS, DSI and APD)

> > http://www.sensoryintegrationhelp.com

> >

> >

> >

[Guest guest]

EDTA is a very good chelator of lead. I'm not aware of any studies

comparing the two, but there certainly may be. I do know that the

answer as to which one is best for lead depends on the doctor to

which you talk.

However, as far as I'm aware doctors are not using EDTA to pull

mercury. THey are using it beofer they use a mercury cheltor like

DMSA or DMPS or ALA. Many docs believe that lead has to come out

before mercury will. So, they use EDTA for awhile in hopes of

getting the lead out so the mercury will be easier to extract. I

think it is pretty well known that, while EDTA can pull some

mercury, it does not have the affinity for mercury that th eother

chelators do.

Ruth

> >

> > This was not a rumor. The doctor used the wrong form of EDTA.

His

> heart stopped as a result of low calcium.

> >

> > The coroner examination indicated cause of death as diffuse,

acute

> cerebral hypoxic-ischemic injury, secondary to diffuse

> subendocardial necrosis. The myocardial necrosis resulted from

> hypocalcemia associated with administration of Na2EDTA.

> >

> > A case of a stupid MD not knowing enough chemistry in order to

> know how to chelate. EDTA is a dinosaur lead chelator. DMSA is far

> better, and unlike any form of EDTA, it will chelate mercury.

> > [ ] JAMA: Deaths Associated With

> Hypocalcemia From Chelation Therapy†" Texas, Pennsylvania, and

> Oregon, 2003-2005

> >

> >

> > I just got this... http://jama.ama-

> assn.org/cgi/content/full/295/18/2131

> >

> > --

> > Rima Regas

> > Mom to Leah, age 8 (AS, DSI and APD)

> > http://www.sensoryintegrationhelp.com

> >

> > ---

> >

> > From the Centers for Disease Control and Prevention:

Morbidity

> and

> > Mortality Weekly Report * Article Options* •

> > Extract<http://jama.ama-

> assn.org/cgi/content/extract/295/18/2131>

> > • PDF <http://jama.ama-assn.org/cgi/reprint/295/18/2131>

> • Send to a

> > Friend<http://jama.ama-assn.org/cgi/mailafriend?

> url=http://jama.ama-

>

assn.org/cgi/content/full/295/18/2131 & title=Deaths+Associated+With+Hy

> pocalcemia+From+Chelation+Therapy--Texas%2C+Pennsylvania%

> 2C+and+Oregon%2C+2003-2005>

> > • Similar articles in this

> > journal<http://jama.ama-assn.org/cgi/search?

> qbe=jama;295/18/2131 & journalcode=jama & minscore=50>

> > * Literature Track* • Add to File

> > Drawer<http://jama.ama-assn.org/cgi/folders?

> action=addtofolder & wherefrom=JOURNALS & wrapped_id=jama;295/18/2131>

> > • Download to Citation

> > Manager<http://jama.ama-assn.org/cgi/citmgr?

> gca=jama;295/18/2131>

> > • Contact me when this article is

> > cited<http://jama.ama-assn.org/cgi/alerts/ctalert?

>

alertType=citedby & addAlert=cited_by & saveAlert=no & cited_by_criteria_re

> sid=jama;295/18/2131 & return_type=article & return_url=%2Fcgi%

2Fcontent%

> 2Ffull%2F295%2F18%2F2131>

> > * Topic Collections* • Occupational and Environmental

> > Medicine<http://jama.ama-

> assn.org/cgi/collection/occupational_and_environmental_medicine>

> > • Adverse Effects <http://jama.ama-

> assn.org/cgi/collection/adverse_effects>

> > • Topic Collection Alerts <http://jama.ama-

> assn.org/cgi/alerts/collalert>

> > * Deaths Associated With Hypocalcemia From Chelation

> Therapy†" Texas,

> > Pennsylvania, and Oregon, 2003-2005 *

> >

> > *JAMA.* 2006;295:2131-2133.

> >

> > *MMWR. 2006;55:204-207*

> >

> > Chelating agents bind lead in soft tissues and are used in

the

> treatment of

> > lead poisoning to enhance urinary and biliary excretion of

> lead, thus

> > decreasing total lead levels in the body. 1 During the past

30

> years,

> > environmental and dietary exposures to lead have decreased

> substantially,

> > resulting in a considerable decrease in population blood

lead

> levels (BLLs)

> > 2 and a corresponding decrease in the number of patients

> requiring chelation

> > therapy. Chelating agents also increase excretion of other

> heavy metals and

> > minerals, such as zinc and, in certain cases, calcium. 1

This

> report

> > describes three deaths associated with chelation-

> therapy†" related hypocalcemia

> > that resulted in cardiac arrest. Several drugs are used in

the

> treatment of

> > lead poisoning, including edetate disodium calcium (CaEDTA),

> dimercaperol

> > (British anti-ite), D-penicillamine, and meso-2,3-

> dimercaptosuccinic

> > acid (succimer). Health-care providers who are unfamiliar

with

> chelating

> > agents and are considering this treatment for lead poisoning

> should consult

> > an expert in the chemotherapy of lead poisoning. Hospital

> pharmacies should

> > evaluate whether continued stocking of Na 2EDTA is

necessary,

> given the

> > established risk for hypocalcemia, the availability of less

> toxic

> > alternatives, and an ongoing safety review by the Food and

Drug

> > Administration (FDA). Health-care providers and pharmacists

> should ensure

> > that Na2EDTA is not administered to children during

chelation

> therapy.

> >

> > Chelating agents, especially those intended for use in

> children, should be

> > effective in reducing lead and other heavy metals from the

> body without

> > producing substantial adverse effects on levels of critical

> serum

> > electrolytes, such as calcium. The only agent recommended

for

> intravenous

> > (IV) chelation therapy for children is CaEDTA.1 However,

> hospital

> > formularies usually stock multiple chelation agents. One

such

> agent, Na2EDTA,

> > was formerly used for treatment of hypercalcemia, but its

use

> has become

> > infrequent because of concerns regarding nephrotoxicity and

> because of the

> > availability of less toxic alternatives.3 Furthermore,

Na2EDTA

> contains a

> > warning stating, " The use of this drug in any particular

> patient is

> > recommended only when the severity of the clinical condition

> justifies the

> > aggressive measures associated with this type of therapy. "

> According to the

> > package insert, Na2EDTA is " indicated in selected patients

for

> the emergency

> > treatment of hypercalcemia and for the control of

ventricular

> arrhythmias

> > associated with digitalis toxicity. " According to FDA and

CDC,

> the safety

> > and effectiveness of Na 2EDTA in pediatric patients has not

> been

> > established, and its use is not recommended because it

induces

> hypocalcemia

> > and possibly fatal tetany.1

> >

> > In 2005, the Texas Department of Health childhood lead

> poisoning surveillance

> > program reported a death attributable to chelation-

associated

> hypocalcemia

> > to CDC. Subsequently, CDC queried state and local lead-

> surveillance programs

> > regarding chelation-related fatalities; additional deaths

were

> identified in

> > Pennsylvania and Oregon.

> >

> > *Case Reports*

> > *Texas*. In February 2005, a girl aged 2 years who was

tested

> for blood lead

> > during routine health surveillance had a capillary BLL of 47

> µg/dL. A venous

> > BLL of 48 µg/dL obtained 12 days later confirmed the

elevated

> BLL. A

> > complete blood count and iron study conducted concurrently

> revealed low

> > serum iron levels and borderline anemia. On February 28,

2005,

> the girl was

> > admitted to a local medical center for combined oral and IV

> chelation

> > therapy.

> >

> > The patient's blood electrolytes at admission were within

> normal limits.

> > Initial medication orders included IV Na2EDTA and oral

> succimer (an agent

> > primarily used for treatment of lead poisoning). The

> medication order

> > subsequently was corrected by the pediatric resident to IV

> CaEDTA. At 4:00

> > p.m. on the day of admission, the patient received her first

> dose of IV

> > CaEDTA (300 mg in 100 mL normal saline at 25 mL/hr). At 4:35

> p.m., she was

> > administered 200 mg of oral succimer. Her vital signs

remained

> normal

> > throughout the night. At 4:00 a.m. the next day, a dose of

IV

> Na2EDTA

> > (instead of IV CaEDTA) was administered. An hour later, the

> patient's serum

> > calcium had decreased to 5.2 mg/dL (normal value for

pediatric

> patients:

> > 8.5-10.5 mg/dL). At 7:05 a.m., the child's mother noticed

that

> the child was

> > limp and not breathing. Bedside procedures did not restore a

> normal cardiac

> > rhythm, and a cardiac resuscitation code was called at 7:25

> a.m. The child

> > had no palpable pulse or audible heartbeat. Repeat

laboratory

> values for

> > serum drawn at 7:55 a.m. indicated that the serum calcium

> level was <5.0 mg/dL

> > despite repeated doses of calcium chloride. All attempts at

> resuscitation

> > failed, and the girl was pronounced dead at 8:12 a.m.

> >

> > An autopsy revealed no results of toxicologic significance.

A

> postmortem

> > radiologic bone survey indicated areas of sclerosis at the

> metaphyses

> > (growth arrest and recovery lines compatible with lead

> exposure). The cause

> > of death was recorded as sudden cardiac arrest resulting

from

> hypocalcemia

> > associated with chelation therapy. The hospital's child

> mortality review

> > board findings indicated that a dose of IV Na2EDTA was

> unintentionally

> > administered to the child.

> >

> > *Pennsylvania*. In August 2005, a boy aged 5 years with

autism

> died while

> > receiving IV chelation therapy with Na2EDTA in a physician's

> office. During

> > the chelation procedure, the mother noted that the child was

> limp. The

> > physician initiated resuscitation, and an emergency services

> team

> > transported the child to the hospital. At the emergency

> department (ED),

> > further resuscitation was attempted, including

administration

> of at least 1

> > and possibly 2 doses of IV calcium chloride. Subsequently,

the

> boy's

> > blood calcium

> > level was recorded in the ED as 6.9 mg/dL. The child did not

> regain

> > consciousness. The coroner examination indicated cause of

> death as diffuse,

> > acute cerebral hypoxic-ischemic injury, secondary to diffuse

> subendocardial

> > necrosis. The myocardial necrosis resulted from hypocalcemia

> associated with

> > administration of Na2EDTA. The case is under investigation

by

> the

> > Pennsylvania State Board of Medicine.

> >

> > *Oregon*. In August 2003, a woman aged 53 years with no

> evidence of coronary

> > artery disease, intracranial disease, or injury was treated

> with 700 mg IV

> > EDTA in a naturopathic practitioner's clinic. The EDTA was

> provided by a

> > compounding laboratory (Creative Compounding, ville,

> Oregon) and was

> > administered by the practitioner to remove heavy metals from

> the body. The

> > practitioner had provided a similar treatment to the patient

> on three

> > previous occasions, once in June 2003 and twice in July 2003.

> > Approximately 10-15

> > minutes after treatment began, the patient became

unconscious.

> Cardiopulmonary

> > resuscitation was initiated, and an emergency services team

> was contacted.

> > Attempts to revive the patient en route to and in the ED

were

> unsuccessful.

> > The medical examiner determined the cause of death to be

> cardiac arrhythmia

> > resulting from hypocalcemia associated with EDTA infusion and

> > vascuolar cardiomyopathy.

> > The patient's ionized calcium level during code was 3.8

mg/dL

> (normal value

> > for adult patients: 4.5-5.3 mg/dL) after one IV injection of

> calcium

> > gluconate administered by emergency medical technicians en

> route to the

> > hospital and another IV injection of calcium chloride in the

> ED. The Oregon

> > State Naturopath Licensing Board is conducting an

> investigation to determine

> > whether Na2EDTA or CaEDTA was administered to this patient.

> >

> > The cases described in this report have been reported to

FDA.

> FDA is

> > performing a safety assessment of Na2EDTA, including a

review

> of the adverse

> > event reporting system to determine whether other deaths

> related to use of

> > chelating agents have been reported.

> >

> >

> > *Reported by:*

> > RA Beauchamp, MD, TM Willis, TG Betz, MD, J Villanacci, PhD,

> Texas Dept of

> > State Health Svcs. RD Leiker, Oregon Childhood Lead

Poisoning

> Prevention

> > Program. L Rozin, MD, Allegheny County, Pennsylvania Office

of

> the Coroner.

> > MJ Brown, ScD, DM Homa, PhD, TA Dignam, MPH, T Morta, Div of

> Emergency and

> > Environmental Health Svcs, National Center for Environmental

> Health, CDC.

> >

> >

> > *CDC Editorial Note:*

> > Both children and adults are subject to potentially lethal

> prescription errors

> > involving " look-alike, sound-alike " substitutions (i.e.,

> confusion of drugs

> > with similar names). In a 1-year study of errors in a

tertiary

> care teaching

> > hospital, 11.4% of medication errors were found to have

> resulted from use of

> > the wrong drug name, dosage form, or abbreviation.4 A review

> of medical

> > records in the Texas case described in this report revealed

> that the brand

> > names for the Na2EDTA product, Endrate® (Hospira, Inc.,

Lake

> Forest,

> > Illinois), and the CaEDTA product, Calcium Disodium Versenate

> ® (3M

> > Pharmaceuticals, St. , Minnesota), were used

> interchangeably; this

> > improper use of drug names likely resulted in the

inappropriate

> > administration of Na2 EDTA.

> >

> > Although CaEDTA and succimer were ordered for one patient

and

> the form of

> > EDTA administered to another remains under investigation,

> these drugs singly

> > or in combination probably were not responsible for the low

> calcium levels.

> > Hypercalcemia as a result of IV administration of CaEDTA has

> been

> > reported.5Succimer by itself is

> > a weak calcium binder but is not associated with a drop in

> essential

> > minerals such as calcium.6 Moreover, the reported doses of

> CaEDTA and

> > succimer in the Texas case were appropriate and within

> established safety

> > limits.

> >

> > Medical center records and coroner reports indicate that

> Na2EDTA was

> > administered in at least two of the cases. Na2EDTA is often

> part of a

> > standard hospital formulary; however, it should never be

used

> for treating

> > lead or other heavy metal poisoning in children because it

> induces

> > hypocalcemia, which can lead to tetany and death.7 The error

> that caused the

> > death in Texas most likely resulted from miscommunication

> between the

> > pharmacy and the pediatric unit.

> >

> > Chelation therapy with CaEDTA, dimercaperol, or succimer has

> been the

> > mainstay of medical management for children with BLLs

[image:

> ≥] 45

> > µg/dL.1The effectiveness of chelation therapy in improving

> renal

> > or nervous system symptoms of chronic mercury toxicity has

not

> been

> > established. Nonetheless, certain health-care practitioners

> have used

> > chelation therapy for autism in the belief that mercury or

> other heavy

> > metals are producing the symptoms.8 Other practitioners have

> recommended

> > chelation therapy for treatment of coronary artery disease,

> hoping to

> > eliminate calcified atherosclerotic plaques that can lead to

> coronary artery

> > occlusions and myocardial infarctions. These off-label uses

of

> chelation

> > therapy are not supported by accepted scientific evidence.

The

> > Institute of Medicine

> > found no scientific evidence that chelation is an effective

> therapy for

> > autism spectrum disorder.8 Because limited consistent data

> exist on the use

> > of chelation therapy to treat coronary artery disease, a

> clinical trial to

> > assess the safety and effectiveness of chelation therapy is

> being conducted

> > by the National Institutes of Health.*

> >

> > Deaths associated with lead poisoning are rare,9 and

childhood

> deaths caused

> > by cardiac arrest associated with chelation therapy have not

> been documented

> > previously.9 As BLLs among children in the United States

> continue to

> > decline,2 fewer children require chelation therapy. Primary

> care providers

> > should consult experts in the chemotherapy of lead before

> using chelation

> > drug therapy. If such an expert is not available, primary

care

> providers

> > should contact state or local childhood lead poisoning

> prevention programs or

> > the Lead Poisoning Prevention Branch of the National Center

for

> > Environmental Health, CDC.

> >

> > CDC and its state and local partners will continue to

educate

> health-care

> > providers and pharmacists to ensure that Na2EDTA is never

> administered to

> > children during chelation therapy. CDC recommends that

> hospital pharmacies

> > evaluate the need to keep Na2EDTA in their formularies. Case

> reports of

> > cardiac arrest or symptoms of hypocalcemia during chelation

> therapy should be

> > reported to the CDC Lead Poisoning Prevention Branch (770-

488-

> 3300) or to

> > MedWatch, the FDA adverse event reporting system, at

> > http://www.fda.gov/medwatch .

> >

> >

> > *Acknowledgments*

> > This report is based, in part, on contributions by M

> Markowitz, MD, Albert

> > Einstein College of Medicine, New York, New York; SI Fisch,

> MD, Valley

> > Baptist Hospital, Harlingen, Texas; and E Strimlan,

Allegheny

> County,

> > Pennsylvania Office of the Coroner.

> >

> > *REFERENCES:* 9 available

> >

> > *Additional information is available at

> > http://nccam.nih.gov/news/2002/chelation/pressrelease.htm

> > .

> >

> >

> >

> >

> >

> >

> > --

> > Rima Regas

> > Mom to Leah, age 8 (AS, DSI and APD)

> > http://www.sensoryintegrationhelp.com

> >

> >

> >

[Guest guest]

Exactly. The other reason some doctors are using EDTA is because

DMSA was ineffective, or there are indications of high lead but not

mercury. (Both true in our case)

I believe there are some studies comparing the efficacy of the two

drugs in the context of acute lead poisoning cited in the PDR, which

I don't have handy.

Darren

> > >

> > > This was not a rumor. The doctor used the wrong form of EDTA.

> His

> > heart stopped as a result of low calcium.

> > >

> > > The coroner examination indicated cause of death as diffuse,

> acute

> > cerebral hypoxic-ischemic injury, secondary to diffuse

> > subendocardial necrosis. The myocardial necrosis resulted from

> > hypocalcemia associated with administration of Na2EDTA.

> > >

> > > A case of a stupid MD not knowing enough chemistry in order to

> > know how to chelate. EDTA is a dinosaur lead chelator. DMSA is

far

> > better, and unlike any form of EDTA, it will chelate mercury.

> > > [ ] JAMA: Deaths Associated With

> > Hypocalcemia From Chelation Therapy†" Texas, Pennsylvania, and

> > Oregon, 2003-2005

> > >

> > >

> > > I just got this... http://jama.ama-

> > assn.org/cgi/content/full/295/18/2131

> > >

> > > --

> > > Rima Regas

> > > Mom to Leah, age 8 (AS, DSI and APD)

> > > http://www.sensoryintegrationhelp.com

> > >

> > > ---

> > >

> > > From the Centers for Disease Control and Prevention:

> Morbidity

> > and

> > > Mortality Weekly Report * Article Options* •

> > > Extract<http://jama.ama-

> > assn.org/cgi/content/extract/295/18/2131>

> > > • PDF <http://jama.ama-

assn.org/cgi/reprint/295/18/2131>

> > • Send to a

> > > Friend<http://jama.ama-assn.org/cgi/mailafriend?

> > url=http://jama.ama-

> >

>

assn.org/cgi/content/full/295/18/2131 & title=Deaths+Associated+With+Hy

> > pocalcemia+From+Chelation+Therapy--Texas%2C+Pennsylvania%

> > 2C+and+Oregon%2C+2003-2005>

> > > • Similar articles in this

> > > journal<http://jama.ama-assn.org/cgi/search?

> > qbe=jama;295/18/2131 & journalcode=jama & minscore=50>

> > > * Literature Track* • Add to File

> > > Drawer<http://jama.ama-assn.org/cgi/folders?

> >

action=addtofolder & wherefrom=JOURNALS & wrapped_id=jama;295/18/2131>

> > > • Download to Citation

> > > Manager<http://jama.ama-assn.org/cgi/citmgr?

> > gca=jama;295/18/2131>

> > > • Contact me when this article is

> > > cited<http://jama.ama-assn.org/cgi/alerts/ctalert?

> >

>

alertType=citedby & addAlert=cited_by & saveAlert=no & cited_by_criteria_re

> > sid=jama;295/18/2131 & return_type=article & return_url=%2Fcgi%

> 2Fcontent%

> > 2Ffull%2F295%2F18%2F2131>

> > > * Topic Collections* • Occupational and Environmental

> > > Medicine<http://jama.ama-

> > assn.org/cgi/collection/occupational_and_environmental_medicine>

> > > • Adverse Effects <http://jama.ama-

> > assn.org/cgi/collection/adverse_effects>

> > > • Topic Collection Alerts <http://jama.ama-

> > assn.org/cgi/alerts/collalert>

> > > * Deaths Associated With Hypocalcemia From Chelation

> > Therapy†" Texas,

> > > Pennsylvania, and Oregon, 2003-2005 *

> > >

> > > *JAMA.* 2006;295:2131-2133.

> > >

> > > *MMWR. 2006;55:204-207*

> > >

> > > Chelating agents bind lead in soft tissues and are used in

> the

> > treatment of

> > > lead poisoning to enhance urinary and biliary excretion of

> > lead, thus

> > > decreasing total lead levels in the body. 1 During the

past

> 30

> > years,

> > > environmental and dietary exposures to lead have decreased

> > substantially,

> > > resulting in a considerable decrease in population blood

> lead

> > levels (BLLs)

> > > 2 and a corresponding decrease in the number of patients

> > requiring chelation

> > > therapy. Chelating agents also increase excretion of other

> > heavy metals and

> > > minerals, such as zinc and, in certain cases, calcium. 1

> This

> > report

> > > describes three deaths associated with chelation-

> > therapy†" related hypocalcemia

> > > that resulted in cardiac arrest. Several drugs are used in

> the

> > treatment of

> > > lead poisoning, including edetate disodium calcium

(CaEDTA),

> > dimercaperol

> > > (British anti-ite), D-penicillamine, and meso-2,3-

> > dimercaptosuccinic

> > > acid (succimer). Health-care providers who are unfamiliar

> with

> > chelating

> > > agents and are considering this treatment for lead

poisoning

> > should consult

> > > an expert in the chemotherapy of lead poisoning. Hospital

> > pharmacies should

> > > evaluate whether continued stocking of Na 2EDTA is

> necessary,

> > given the

> > > established risk for hypocalcemia, the availability of

less

> > toxic

> > > alternatives, and an ongoing safety review by the Food and

> Drug

> > > Administration (FDA). Health-care providers and

pharmacists

> > should ensure

> > > that Na2EDTA is not administered to children during

> chelation

> > therapy.

> > >

> > > Chelating agents, especially those intended for use in

> > children, should be

> > > effective in reducing lead and other heavy metals from the

> > body without

> > > producing substantial adverse effects on levels of

critical

> > serum

> > > electrolytes, such as calcium. The only agent recommended

> for

> > intravenous

> > > (IV) chelation therapy for children is CaEDTA.1 However,

> > hospital

> > > formularies usually stock multiple chelation agents. One

> such

> > agent, Na2EDTA,

> > > was formerly used for treatment of hypercalcemia, but its

> use

> > has become

> > > infrequent because of concerns regarding nephrotoxicity

and

> > because of the

> > > availability of less toxic alternatives.3 Furthermore,

> Na2EDTA

> > contains a

> > > warning stating, " The use of this drug in any particular

> > patient is

> > > recommended only when the severity of the clinical

condition

> > justifies the

> > > aggressive measures associated with this type of therapy. "

> > According to the

> > > package insert, Na2EDTA is " indicated in selected patients

> for

> > the emergency

> > > treatment of hypercalcemia and for the control of

> ventricular

> > arrhythmias

> > > associated with digitalis toxicity. " According to FDA and

> CDC,

> > the safety

> > > and effectiveness of Na 2EDTA in pediatric patients has

not

> > been

> > > established, and its use is not recommended because it

> induces

> > hypocalcemia

> > > and possibly fatal tetany.1

> > >

> > > In 2005, the Texas Department of Health childhood lead

> > poisoning surveillance

> > > program reported a death attributable to chelation-

> associated

> > hypocalcemia

> > > to CDC. Subsequently, CDC queried state and local lead-

> > surveillance programs

> > > regarding chelation-related fatalities; additional deaths

> were

> > identified in

> > > Pennsylvania and Oregon.

> > >

> > > *Case Reports*

> > > *Texas*. In February 2005, a girl aged 2 years who was

> tested

> > for blood lead

> > > during routine health surveillance had a capillary BLL of

47

> > µg/dL. A venous

> > > BLL of 48 µg/dL obtained 12 days later confirmed the

> elevated

> > BLL. A

> > > complete blood count and iron study conducted concurrently

> > revealed low

> > > serum iron levels and borderline anemia. On February 28,

> 2005,

> > the girl was

> > > admitted to a local medical center for combined oral and

IV

> > chelation

> > > therapy.

> > >

> > > The patient's blood electrolytes at admission were within

> > normal limits.

> > > Initial medication orders included IV Na2EDTA and oral

> > succimer (an agent

> > > primarily used for treatment of lead poisoning). The

> > medication order

> > > subsequently was corrected by the pediatric resident to IV

> > CaEDTA. At 4:00

> > > p.m. on the day of admission, the patient received her

first

> > dose of IV

> > > CaEDTA (300 mg in 100 mL normal saline at 25 mL/hr). At

4:35

> > p.m., she was

> > > administered 200 mg of oral succimer. Her vital signs

> remained

> > normal

> > > throughout the night. At 4:00 a.m. the next day, a dose of

> IV

> > Na2EDTA

> > > (instead of IV CaEDTA) was administered. An hour later,

the

> > patient's serum

> > > calcium had decreased to 5.2 mg/dL (normal value for

> pediatric

> > patients:

> > > 8.5-10.5 mg/dL). At 7:05 a.m., the child's mother noticed

> that

> > the child was

> > > limp and not breathing. Bedside procedures did not restore

a

> > normal cardiac

> > > rhythm, and a cardiac resuscitation code was called at

7:25

> > a.m. The child

> > > had no palpable pulse or audible heartbeat. Repeat

> laboratory

> > values for

> > > serum drawn at 7:55 a.m. indicated that the serum calcium

> > level was <5.0 mg/dL

> > > despite repeated doses of calcium chloride. All attempts

at

> > resuscitation

> > > failed, and the girl was pronounced dead at 8:12 a.m.

> > >

> > > An autopsy revealed no results of toxicologic

significance.

> A

> > postmortem

> > > radiologic bone survey indicated areas of sclerosis at the

> > metaphyses

> > > (growth arrest and recovery lines compatible with lead

> > exposure). The cause

> > > of death was recorded as sudden cardiac arrest resulting

> from

> > hypocalcemia

> > > associated with chelation therapy. The hospital's child

> > mortality review

> > > board findings indicated that a dose of IV Na2EDTA was

> > unintentionally

> > > administered to the child.

> > >

> > > *Pennsylvania*. In August 2005, a boy aged 5 years with

> autism

> > died while

> > > receiving IV chelation therapy with Na2EDTA in a

physician's

> > office. During

> > > the chelation procedure, the mother noted that the child

was

> > limp. The

> > > physician initiated resuscitation, and an emergency

services

> > team

> > > transported the child to the hospital. At the emergency

> > department (ED),

> > > further resuscitation was attempted, including

> administration

> > of at least 1

> > > and possibly 2 doses of IV calcium chloride. Subsequently,

> the

> > boy's

> > > blood calcium

> > > level was recorded in the ED as 6.9 mg/dL. The child did

not

> > regain

> > > consciousness. The coroner examination indicated cause of

> > death as diffuse,

> > > acute cerebral hypoxic-ischemic injury, secondary to

diffuse

> > subendocardial

> > > necrosis. The myocardial necrosis resulted from

hypocalcemia

> > associated with

> > > administration of Na2EDTA. The case is under investigation

> by

> > the

> > > Pennsylvania State Board of Medicine.

> > >

> > > *Oregon*. In August 2003, a woman aged 53 years with no

> > evidence of coronary

> > > artery disease, intracranial disease, or injury was

treated

> > with 700 mg IV

> > > EDTA in a naturopathic practitioner's clinic. The EDTA was

> > provided by a

> > > compounding laboratory (Creative Compounding, ville,

> > Oregon) and was

> > > administered by the practitioner to remove heavy metals

from

> > the body. The

> > > practitioner had provided a similar treatment to the

patient

> > on three

> > > previous occasions, once in June 2003 and twice in July

2003.

> > > Approximately 10-15

> > > minutes after treatment began, the patient became

> unconscious.

> > Cardiopulmonary

> > > resuscitation was initiated, and an emergency services

team

> > was contacted.

> > > Attempts to revive the patient en route to and in the ED

> were

> > unsuccessful.

> > > The medical examiner determined the cause of death to be

> > cardiac arrhythmia

> > > resulting from hypocalcemia associated with EDTA infusion

and

> > > vascuolar cardiomyopathy.

> > > The patient's ionized calcium level during code was 3.8

> mg/dL

> > (normal value

> > > for adult patients: 4.5-5.3 mg/dL) after one IV injection

of

> > calcium

> > > gluconate administered by emergency medical technicians en

> > route to the

> > > hospital and another IV injection of calcium chloride in

the

> > ED. The Oregon

> > > State Naturopath Licensing Board is conducting an

> > investigation to determine

> > > whether Na2EDTA or CaEDTA was administered to this patient.

> > >

> > > The cases described in this report have been reported to

> FDA.

> > FDA is

> > > performing a safety assessment of Na2EDTA, including a

> review

> > of the adverse

> > > event reporting system to determine whether other deaths

> > related to use of

> > > chelating agents have been reported.

> > >

> > >

> > > *Reported by:*

> > > RA Beauchamp, MD, TM Willis, TG Betz, MD, J Villanacci,

PhD,

> > Texas Dept of

> > > State Health Svcs. RD Leiker, Oregon Childhood Lead

> Poisoning

> > Prevention

> > > Program. L Rozin, MD, Allegheny County, Pennsylvania

Office

> of

> > the Coroner.

> > > MJ Brown, ScD, DM Homa, PhD, TA Dignam, MPH, T Morta, Div

of

> > Emergency and

> > > Environmental Health Svcs, National Center for

Environmental

> > Health, CDC.

> > >

> > >

> > > *CDC Editorial Note:*

> > > Both children and adults are subject to potentially lethal

> > prescription errors

> > > involving " look-alike, sound-alike " substitutions (i.e.,

> > confusion of drugs

> > > with similar names). In a 1-year study of errors in a

> tertiary

> > care teaching

> > > hospital, 11.4% of medication errors were found to have

> > resulted from use of

> > > the wrong drug name, dosage form, or abbreviation.4 A

review

> > of medical

> > > records in the Texas case described in this report

revealed

> > that the brand

> > > names for the Na2EDTA product, Endrate® (Hospira, Inc.,

> Lake

> > Forest,

> > > Illinois), and the CaEDTA product, Calcium Disodium

Versenate

> > ® (3M

> > > Pharmaceuticals, St. , Minnesota), were used

> > interchangeably; this

> > > improper use of drug names likely resulted in the

> inappropriate

> > > administration of Na2 EDTA.

> > >

> > > Although CaEDTA and succimer were ordered for one patient

> and

> > the form of

> > > EDTA administered to another remains under investigation,

> > these drugs singly

> > > or in combination probably were not responsible for the

low

> > calcium levels.

> > > Hypercalcemia as a result of IV administration of CaEDTA

has

> > been

> > > reported.5Succimer by itself is

> > > a weak calcium binder but is not associated with a drop in

> > essential

> > > minerals such as calcium.6 Moreover, the reported doses of

> > CaEDTA and

> > > succimer in the Texas case were appropriate and within

> > established safety

> > > limits.

> > >

> > > Medical center records and coroner reports indicate that

> > Na2EDTA was

> > > administered in at least two of the cases. Na2EDTA is

often

> > part of a

> > > standard hospital formulary; however, it should never be

> used

> > for treating

> > > lead or other heavy metal poisoning in children because it

> > induces

> > > hypocalcemia, which can lead to tetany and death.7 The

error

> > that caused the

> > > death in Texas most likely resulted from miscommunication

> > between the

> > > pharmacy and the pediatric unit.

> > >

> > > Chelation therapy with CaEDTA, dimercaperol, or succimer

has

> > been the

> > > mainstay of medical management for children with BLLs

> [image:

> > ≥] 45

> > > µg/dL.1The effectiveness of chelation therapy in

improving

> > renal

> > > or nervous system symptoms of chronic mercury toxicity has

> not

> > been

> > > established. Nonetheless, certain health-care

practitioners

> > have used

> > > chelation therapy for autism in the belief that mercury or

> > other heavy

> > > metals are producing the symptoms.8 Other practitioners

have

> > recommended

> > > chelation therapy for treatment of coronary artery

disease,

> > hoping to

> > > eliminate calcified atherosclerotic plaques that can lead

to

> > coronary artery

> > > occlusions and myocardial infarctions. These off-label

uses

> of

> > chelation

> > > therapy are not supported by accepted scientific evidence.

> The

> > > Institute of Medicine

> > > found no scientific evidence that chelation is an

effective

> > therapy for

> > > autism spectrum disorder.8 Because limited consistent data

> > exist on the use

> > > of chelation therapy to treat coronary artery disease, a

> > clinical trial to

> > > assess the safety and effectiveness of chelation therapy

is

> > being conducted

> > > by the National Institutes of Health.*

> > >

> > > Deaths associated with lead poisoning are rare,9 and

> childhood

> > deaths caused

> > > by cardiac arrest associated with chelation therapy have

not

> > been documented

> > > previously.9 As BLLs among children in the United States

> > continue to

> > > decline,2 fewer children require chelation therapy.

Primary

> > care providers

> > > should consult experts in the chemotherapy of lead before

> > using chelation

> > > drug therapy. If such an expert is not available, primary

> care

> > providers

> > > should contact state or local childhood lead poisoning

> > prevention programs or

> > > the Lead Poisoning Prevention Branch of the National

Center

> for

> > > Environmental Health, CDC.

> > >

> > > CDC and its state and local partners will continue to

> educate

> > health-care

> > > providers and pharmacists to ensure that Na2EDTA is never

> > administered to

> > > children during chelation therapy. CDC recommends that

> > hospital pharmacies

> > > evaluate the need to keep Na2EDTA in their formularies.

Case

> > reports of

> > > cardiac arrest or symptoms of hypocalcemia during

chelation

> > therapy should be

> > > reported to the CDC Lead Poisoning Prevention Branch (770-

> 488-

> > 3300) or to

> > > MedWatch, the FDA adverse event reporting system, at

> > > http://www.fda.gov/medwatch .

> > >

> > >

> > > *Acknowledgments*

> > > This report is based, in part, on contributions by M

> > Markowitz, MD, Albert

> > > Einstein College of Medicine, New York, New York; SI

Fisch,

> > MD, Valley

> > > Baptist Hospital, Harlingen, Texas; and E Strimlan,

> Allegheny

> > County,

> > > Pennsylvania Office of the Coroner.

> > >

> > > *REFERENCES:* 9 available

> > >

> > > *Additional information is available at

> > > http://nccam.nih.gov/news/2002/chelation/pressrelease.htm

> > > .

> > >

> > >

> > >

> > >

> > >

> > >

> > > --

> > > Rima Regas

> > > Mom to Leah, age 8 (AS, DSI and APD)

> > > http://www.sensoryintegrationhelp.com

> > >

> > >

> > >

[Guest guest]

> Exactly. The other reason some doctors are using EDTA is because

> DMSA was ineffective,

This is not correct.

They use EDTA solely because they are famiilar with it. It is used for other

things (vascular

disease) quite a bit so if you go find a 'chelation doctor' you usually end up

with an EDTA

doctor.

DMSA is more effective for lead than EDTA is.

DMSA has no risks of perturbing calcium or zinc balance, unlike EDTA.

EDTA is not effective for the treatment of mercury poisoning (as was well known

and

stated in textbooks in the 1970's before DMSA or DMPS was available) even though

it does

modestly increase urine mercury levels.

If you're seeing a doctor who uses EDTA for autistic children you're seeing the

wrong kind

of doctor. You should let them stick to vascular disease and find one who knows

how to

handle autism.

The only exception to this is when there is a lot of lead, not much sign of

mercury AND

there have repeatedly been problems with the use of DMSA so that it can't be

used any

more. In that case EDTA by mouth every 8 hours is appropriate.

Andy

[Guest guest]

>

> EDTA is a very good chelator of lead. I'm not aware of any studies

> comparing the two, but there certainly may be. I do know that the

> answer as to which one is best for lead depends on the doctor to

> which you talk.

>

The answer you get may change, the truth does not.

People seem not to get that and to put their children at tremendous risk of

permanent

serious further harm by not understanding that external reality is neither

changed by a

doctor's opinion nor is it accurately reflected in may doctor's opinions.

Andy