E-NEWS FROM THE NATIONAL VACCINE INFORMATION CENTER
Vienna, Virginia http://www.nvic.org
* * * * * * * * * * * * * * * * * * * * * * *
UNITED WAY/COMBINED FEDERAL CAMPAIGN
* * * * * * * * * * * * * * * * * * * * * * *
"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.
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-Lewisite), 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.
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
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, Wilsonville, 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
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. Paul, 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
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.
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
News@nvic.org 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
Become a member and support NVIC's work
To sign up for a free e-mail subscription http://www.nvic.org/emaillist.htm
To unsubscribe from this list, please go to
http://nvic.org/emaillistunsub.htm or send an email to
email@example.com and type UNSUBSCRIBE in the body of the email.
NVIC is funded through individual membership donations and does not receive
government funding. Barbara Loe Fisher, President and Co-founder.
NOTE: This is not an interactive e-mail list. Please do not respond to