FDA Issues Chelation Therapy Warning

Stephen Barrett, M.D.
Robert S. Baratz, M.D., D.D.S., Ph.D.

The name "EDTA" is often used to refer to two separate drugs: Disodium EDTA (edetate disodium, also known as Endrate® and generic versions); and Calcium disodium EDTA (also known as Calcium Disodium Versenate and Versenate®).The FDA has issued a public health advisory to warn patients and healthcare professionals about misuse of these drugs and confusion about "EDTA." [1].

Both drugs bind to (chelate) certain molecules to speed their excretion from the body. When edetate disodium is injected into the blood stream, it binds to calcium and improper administration can cause fatal decreases in blood calcium levels. Edetate disodium is approved for only treating critically high blood calcium levels, which are rare. Even for that, it is seldom used nowadays because safer methods of reducing serum calcium are available. Calcium Disodium Versenate strongly binds to lead and is approved only for serious cases of lead poisoning. Lesser cases of lead poisoning are treated in other ways.

Several people have died when edetate sodium was used for "chelation therapy" or other uses that are not FDA-approved. A few children have died when given it by mistake. As a result, the agency is reviewing its status [2].

Both drugs have been used in chelation therapies that are falsely claimed to improve the cardiovascular system, and treat autism and various other diseases that practitioners falsely attribute to heavy metal poisoning [3]. Neither drug is approved for treating "heavy metal toxicity." The recommended administration of Calcium Disodium Versenate is intramuscular, not intravenous as used by "chelation therapists."

At least 20 deaths have been reported with use of intravenous edetate disodium for allegedly treating vascular disease. The patients were not warned about the danger and were misled to believe that this agent was safe, effective, and a "chemical roto-rooter" for treating cardiovascular disease. None of these subjects had heavy metal intoxication. Because chelation therapists generally prefer to use edetate sodium, removing it as an approved drug or restricting its use to hospitals would make it much more difficult to market "EDTA chelation therapy."

On the same day that the FDA issued its warning, Endrate's manufacturer (Hospira Inc.) initiated a voluntary recall of two lots of Endrate and announced that it would withdraw its New Drug Application and would no longer market the product. The announcement stated:

Hospira is aware of published reports of fatal medication errors associated with the off-label use of Edetate Disodium. Based on the limited indications for Endrate and the availability of alternate medical products, the product is no longer medically necessary [4].

A few months later, Bioniche, which marketed a generic version of disodium edetate, stopped selling it, which means that the drug is no longer available in the United States from a company that is legally permitted to sell it. However, most of the preparations chelation therapists use are sold by compounding pharmacies that cater to "alternative" practitioners. Some of these vendors appear to selling “house brands” of disodium edetate that lack FDA approval. We believe that all sales of sodium edetate should be stopped.

References

  1. Edetate disodium (marketed as Endrate and generic products), FDA Public Health Advisory, Jan 16, 2008.
  2. Questions and answers on edetate sodium. FDA Center for Drug Evaluation and Research, Jan 16, 2008.
  3. Barrett S, Baratz RS. Chelation therapy and insurance fraud. Quackwatch, May 11, 2000.
  4. Bloomberg News. Hospira voluntarily withdraws Endrate. Chicago Tribune, January 17, 2008.

This article was revised on September 26, 2008.

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