[NVIC] Chelation Therapy Under Attack

[Guest guest]

E-NEWS FROM THE NATIONAL VACCINE INFORMATION CENTER

Vienna, Virginia http://www.nvic.org

* * * * * * * * * * * * * * * * * * * * * * *

UNITED WAY/COMBINED FEDERAL CAMPAIGN

#8122

* * * * * * * * * * * * * * * * * * * * * * *

" Protecting the health and informed consent rights of children since 1982. "

============================================================================

==============

BL Fisher Note:

This article in MMWR details the inappropriate use of Na2EDTA chelation

therapy for adults in children and the subsequent death of the children. It

is well known that children undergoing chelation therapy should receive

CaEDTA and not Na2EDTA.

The death of these children was caused by incompetent physicians and not

chelation therapy itself. Nevertheless, this article gives fair warning to

doctors and the public that the days of chelation therapy in the US are

coming to an end.

CDC officials, who maintain autism is a genetic disorder and irreversible,

cannot tolerate the existence of children whose autistic behaviors have

disappeared after chelation therapy removes vaccine-related mercury and

other toxins from their bodies.

Prediction: CDC and FDA officials will move to ban chelation therapy in the

U.S. and parents of autistic children will be forced to seek chelation

therapy outside U.S. borders.

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5508a3.htm

March 3, 2006 / 55(08);204-207

Deaths Associated with Hypocalcemia from Chelation Therapy --- Texas,

Pennsylvania, and Oregon, 2003--2005

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 Na2EDTA 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 Na2EDTA 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.

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 Na2EDTA.

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

(5). Succimer 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 >45 µg/dL (1). The

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

CDC. Preventing lead poisoning in young children: a statement by the Centers

for Disease Control. Atlanta, GA: CDC; 1985.

CDC. Blood lead levels---United States, 1999--2002. MMWR 2005;54:513--6.

Wedeen RP, Batuman V, Landy E. The safety of the EDTA lead-mobilization

test. Environ Res 1983;30:58--62.

Lesar TS, Briceland L, Stein DS. Factors related to errors in medication

prescribing. JAMA 1997;277:312--7.

Chisolm, JJ Jr. The use of chelating agents in the treatment of acute and

chronic lead intoxication in childhood. J Pediatri 1968;73:1--38.

Aposhian HV, Aposhian MM. meso-2,3-dimercaptosuccinic acid: chemical,

pharmacological and toxicological properties of an orally effective metal

chelating agent. Annu Rev Pharmacol Toxicol 1990;20:279--306.

Agency for Toxic Substances and Disease Registry. Toxicological profile for

lead. Atlanta, GA: US Department Health and Human Services, Agency for Toxic

Substances and Disease Registry; 1999.

Institute of Medicine. Immunization safety review: vaccines and autism.

Washington, DC: National Academies Press; 2004.

Kaufmann RB, Staes CJ, Matte TD. Deaths related to lead poisoning in the

United States, 1979--1998. Environ Res 2003;91:78--84.

* Additional information is available at

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

=============================================

News@... is a free service of the National Vaccine Information

Center and is supported through membership donations. Learn more about

vaccines, diseases and how to protect your informed consent rights

http://www.nvic.org

Become a member and support NVIC's work

https://www.nvic.org/making%20cash%20donations.htm

To sign up for a free e-mail subscription http://www.nvic.org/emaillist.htm

[Guest guest]

-

The people at the CDC are worse then the Nazi scientist that were in

Germany!

Donna

-- In Vaccinations , Sheri Nakken <snakken@...> wrote:

>

> E-NEWS FROM THE NATIONAL VACCINE INFORMATION CENTER

> Vienna, Virginia http://www.nvic.org

>

> * * * * * * * * * * * * * * * * * * * * * * *

> UNITED WAY/COMBINED FEDERAL CAMPAIGN

> #8122

> * * * * * * * * * * * * * * * * * * * * * * *

>

> " Protecting the health and informed consent rights of children

since 1982. "

>

>

=====================================================================

=======

> ==============

> BL Fisher Note:

>

> This article in MMWR details the inappropriate use of Na2EDTA

chelation

> therapy for adults in children and the subsequent death of the

children. It

> is well known that children undergoing chelation therapy should

receive

> CaEDTA and not Na2EDTA.

>

> The death of these children was caused by incompetent physicians

and not

> chelation therapy itself. Nevertheless, this article gives fair

warning to

> doctors and the public that the days of chelation therapy in the

US are

> coming to an end.

>

> CDC officials, who maintain autism is a genetic disorder and

irreversible,

> cannot tolerate the existence of children whose autistic behaviors

have

> disappeared after chelation therapy removes vaccine-related

mercury and

> other toxins from their bodies.

>

> Prediction: CDC and FDA officials will move to ban chelation

therapy in the

> U.S. and parents of autistic children will be forced to seek

chelation

> therapy outside U.S. borders.

>

>

>

> http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5508a3.htm

> March 3, 2006 / 55(08);204-207

>

> Deaths Associated with Hypocalcemia from Chelation Therapy ---

Texas,

> Pennsylvania, and Oregon, 2003--2005

>

> 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

Na2EDTA 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 Na2EDTA 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.

>

> 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 Na2EDTA.

>

> 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

> (5). Succimer 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 >45 µg/dL

(1). The

> 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

>

> CDC. Preventing lead poisoning in young children: a statement by

the Centers

> for Disease Control. Atlanta, GA: CDC; 1985.

> CDC. Blood lead levels---United States, 1999--2002. MMWR

2005;54:513--6.

> Wedeen RP, Batuman V, Landy E. The safety of the EDTA lead-

mobilization

> test. Environ Res 1983;30:58--62.

> Lesar TS, Briceland L, Stein DS. Factors related to errors in

medication

> prescribing. JAMA 1997;277:312--7.

> Chisolm, JJ Jr. The use of chelating agents in the treatment of

acute and

> chronic lead intoxication in childhood. J Pediatri 1968;73:1--38.

> Aposhian HV, Aposhian MM. meso-2,3-dimercaptosuccinic acid:

chemical,

> pharmacological and toxicological properties of an orally

effective metal

> chelating agent. Annu Rev Pharmacol Toxicol 1990;20:279--306.

> Agency for Toxic Substances and Disease Registry. Toxicological

profile for

> lead. Atlanta, GA: US Department Health and Human Services, Agency

for Toxic

> Substances and Disease Registry; 1999.

> Institute of Medicine. Immunization safety review: vaccines and

autism.

> Washington, DC: National Academies Press; 2004.

> Kaufmann RB, Staes CJ, Matte TD. Deaths related to lead poisoning

in the

> United States, 1979--1998. Environ Res 2003;91:78--84.

>

> * Additional information is available at

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

>

>

>

> =============================================

> News@... is a free service of the National Vaccine Information

> Center and is supported through membership donations. Learn more

about

> vaccines, diseases and how to protect your informed consent rights

> http://www.nvic.org

>

> Become a member and support NVIC's work

> https://www.nvic.org/making%20cash%20donations.htm

>

> To sign up for a free e-mail subscription

http://www.nvic.org/emaillist.htm

>

>

[Guest guest]

I know several people, on of whom is quite close to me (you have to be careful

since this isn't really legal) who are making incredible progress with

chelation. From non-verbal to speaking in sentences. And they want to take

that away from these children because if it works then they have to admit that

something they're doing is wrong. And we all know that THAT ain't going

anywhere!

Sheri B.

Donna <donna.arnold@...> wrote:

-

The people at the CDC are worse then the Nazi scientist that were in

Germany!

Donna

-- In Vaccinations , Sheri Nakken <snakken@...> wrote:

>

> E-NEWS FROM THE NATIONAL VACCINE INFORMATION CENTER

> Vienna, Virginia http://www.nvic.org

>

> * * * * * * * * * * * * * * * * * * * * * * *

> UNITED WAY/COMBINED FEDERAL CAMPAIGN

> #8122

> * * * * * * * * * * * * * * * * * * * * * * *

>

> " Protecting the health and informed consent rights of children

since 1982. "

>

>

=====================================================================

=======

> ==============

> BL Fisher Note:

>

> This article in MMWR details the inappropriate use of Na2EDTA

chelation

> therapy for adults in children and the subsequent death of the

children. It

> is well known that children undergoing chelation therapy should

receive

> CaEDTA and not Na2EDTA.

>

> The death of these children was caused by incompetent physicians

and not

> chelation therapy itself. Nevertheless, this article gives fair

warning to

> doctors and the public that the days of chelation therapy in the

US are

> coming to an end.

>

> CDC officials, who maintain autism is a genetic disorder and

irreversible,

> cannot tolerate the existence of children whose autistic behaviors

have

> disappeared after chelation therapy removes vaccine-related

mercury and

> other toxins from their bodies.

>

> Prediction: CDC and FDA officials will move to ban chelation

therapy in the

> U.S. and parents of autistic children will be forced to seek

chelation

> therapy outside U.S. borders.

>

>

>

> http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5508a3.htm

> March 3, 2006 / 55(08);204-207

>

> Deaths Associated with Hypocalcemia from Chelation Therapy ---

Texas,

> Pennsylvania, and Oregon, 2003--2005

>

> 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

Na2EDTA 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 Na2EDTA 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.

>

> 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 Na2EDTA.

>

> 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

> (5). Succimer 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 >45 µg/dL

(1). The

> 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

>

> CDC. Preventing lead poisoning in young children: a statement by

the Centers

> for Disease Control. Atlanta, GA: CDC; 1985.

> CDC. Blood lead levels---United States, 1999--2002. MMWR

2005;54:513--6.

> Wedeen RP, Batuman V, Landy E. The safety of the EDTA lead-

mobilization

> test. Environ Res 1983;30:58--62.

> Lesar TS, Briceland L, Stein DS. Factors related to errors in

medication

> prescribing. JAMA 1997;277:312--7.

> Chisolm, JJ Jr. The use of chelating agents in the treatment of

acute and

> chronic lead intoxication in childhood. J Pediatri 1968;73:1--38.

> Aposhian HV, Aposhian MM. meso-2,3-dimercaptosuccinic acid:

chemical,

> pharmacological and toxicological properties of an orally

effective metal

> chelating agent. Annu Rev Pharmacol Toxicol 1990;20:279--306.

> Agency for Toxic Substances and Disease Registry. Toxicological

profile for

> lead. Atlanta, GA: US Department Health and Human Services, Agency

for Toxic

> Substances and Disease Registry; 1999.

> Institute of Medicine. Immunization safety review: vaccines and

autism.

> Washington, DC: National Academies Press; 2004.

> Kaufmann RB, Staes CJ, Matte TD. Deaths related to lead poisoning

in the

> United States, 1979--1998. Environ Res 2003;91:78--84.

>

> * Additional information is available at

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

>

>

>

> =============================================

> News@... is a free service of the National Vaccine Information

> Center and is supported through membership donations. Learn more

about

> vaccines, diseases and how to protect your informed consent rights

> http://www.nvic.org

>

> Become a member and support NVIC's work

> https://www.nvic.org/making%20cash%20donations.htm

>

> To sign up for a free e-mail subscription

http://www.nvic.org/emaillist.htm

>

>

[Guest guest]

What will happen to poor Phamra if all the kids get better??? I

hate Pharma, they are the slime of the earth!

The vast majority of children with autism spectrum disorder can be

treated to achieve significant improvements in communication and

socialization. For two years now, DAN!™ has featured live

demonstrations or video records of recovered children. The Autism

Research Institute knows of 1000 cases of recovery.

http://www.danconference.com/springLetter.htm

Thats 1000 kids in two years, I know it takes months and even years

to reverse the damage Pharma has caused! This also does not include

the ones who are healed by using someone else besides a DAN Dr.

Donna

> >

> > E-NEWS FROM THE NATIONAL VACCINE INFORMATION CENTER

> > Vienna, Virginia http://www.nvic.org

> >

> > * * * * * * * * * * * * * * * * * * * * * * *

> > UNITED WAY/COMBINED FEDERAL CAMPAIGN

> > #8122

> > * * * * * * * * * * * * * * * * * * * * * * *

> >

> > " Protecting the health and informed consent rights of children

> since 1982. "

> >

> >

>

=====================================================================

> =======

> > ==============

> > BL Fisher Note:

> >

> > This article in MMWR details the inappropriate use of Na2EDTA

> chelation

> > therapy for adults in children and the subsequent death of the

> children. It

> > is well known that children undergoing chelation therapy should

> receive

> > CaEDTA and not Na2EDTA.

> >

> > The death of these children was caused by incompetent physicians

> and not

> > chelation therapy itself. Nevertheless, this article gives fair

> warning to

> > doctors and the public that the days of chelation therapy in the

> US are

> > coming to an end.

> >

> > CDC officials, who maintain autism is a genetic disorder and

> irreversible,

> > cannot tolerate the existence of children whose autistic

behaviors

> have

> > disappeared after chelation therapy removes vaccine-related

> mercury and

> > other toxins from their bodies.

> >

> > Prediction: CDC and FDA officials will move to ban chelation

> therapy in the

> > U.S. and parents of autistic children will be forced to seek

> chelation

> > therapy outside U.S. borders.

> >

> >

> >

> > http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5508a3.htm

> > March 3, 2006 / 55(08);204-207

> >

> > Deaths Associated with Hypocalcemia from Chelation Therapy ---

> Texas,

> > Pennsylvania, and Oregon, 2003--2005

> >

> > 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

> Na2EDTA 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 Na2EDTA 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.

> >

> > 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 Na2EDTA.

> >

> > 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

> > (5). Succimer 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 >45 µg/dL

> (1). The

> > 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

> >

> > CDC. Preventing lead poisoning in young children: a statement by

> the Centers

> > for Disease Control. Atlanta, GA: CDC; 1985.

> > CDC. Blood lead levels---United States, 1999--2002. MMWR

> 2005;54:513--6.

> > Wedeen RP, Batuman V, Landy E. The safety of the EDTA lead-

> mobilization

> > test. Environ Res 1983;30:58--62.

> > Lesar TS, Briceland L, Stein DS. Factors related to errors in

> medication

> > prescribing. JAMA 1997;277:312--7.

> > Chisolm, JJ Jr. The use of chelating agents in the treatment of

> acute and

> > chronic lead intoxication in childhood. J Pediatri 1968;73:1--38.

> > Aposhian HV, Aposhian MM. meso-2,3-dimercaptosuccinic acid:

> chemical,

> > pharmacological and toxicological properties of an orally

> effective metal

> > chelating agent. Annu Rev Pharmacol Toxicol 1990;20:279--306.

> > Agency for Toxic Substances and Disease Registry. Toxicological

> profile for

> > lead. Atlanta, GA: US Department Health and Human Services,

Agency

> for Toxic

> > Substances and Disease Registry; 1999.

> > Institute of Medicine. Immunization safety review: vaccines and

> autism.

> > Washington, DC: National Academies Press; 2004.

> > Kaufmann RB, Staes CJ, Matte TD. Deaths related to lead

poisoning

> in the

> > United States, 1979--1998. Environ Res 2003;91:78--84.

> >

> > * Additional information is available at

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

> >

> >

> >

> > =============================================

> > News@ is a free service of the National Vaccine Information

> > Center and is supported through membership donations. Learn

more

> about

> > vaccines, diseases and how to protect your informed consent

rights

> > http://www.nvic.org

> >

> > Become a member and support NVIC's work

> > https://www.nvic.org/making%20cash%20donations.htm

> >

> > To sign up for a free e-mail subscription

> http://www.nvic.org/emaillist.htm

> >

> >

[Guest guest]

what will happen if someone has an autistic child who was cured into a

talking normal child, will they jail the parents from it, and take the

child and re-vaccinate him to make him autistic again???

[Guest guest]

Doubt that would happen (but who knows?). They could very well take him if they

found out she was chelating.

Sheri B.

---------------------------------

Bring photos to life! New PhotoMail makes sharing a breeze.