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

[Guest guest]

Basic chemistry.

[ ] JAMA: Deaths Associated With

Hypocalcemia From Chelation Therapyâ? " 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* â?¢

> Extract<http://jama.ama-

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

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

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

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> * Deaths Associated With Hypocalcemia From Chelation

Therapyâ? " 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-

therapyâ? " 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:

â?¥] 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]

What does that mean? Are you saying that the package insert for

CaNa2EDTA is wrong when it says that it will bond with mercury

(albeit with a lower preference than for lead)?

> >

> > 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 Therapyâ? " 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* â?¢

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

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

> > â?¢ PDF <http://jama.ama-

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

> â?¢ 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>

> > â?¢ Similar articles in this

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

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

> > * Literature Track* â?¢ Add to File

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

>

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

> > â?¢ Download to Citation

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

> gca=jama;295/18/2131>

> > â?¢ 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* â?¢ Occupational and Environmental

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

> assn.org/cgi/collection/occupational_and_environmental_medicine>

> > â?¢ Adverse Effects <http://jama.ama-

> assn.org/cgi/collection/adverse_effects>

> > â?¢ Topic Collection Alerts <http://jama.ama-

> assn.org/cgi/alerts/collalert>

> > * Deaths Associated With Hypocalcemia From Chelation

> Therapyâ? " 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-

> therapyâ? " 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:

> â?¥] 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

> >

> >

> >