FDA Public Health Advisory: Edetate Disodium
(Marketed as Endrate and Generic Products)

FDA Center for Drug Evaluation and Research
January 16, 2008

FDA is issuing this public health advisory to alert patients and healthcare professionals aboutimportant safety information concerning the drug Edetate Disodium. There have been cases where children and adults have died when they were mistakenly given Edetate Disodium instead of Edetate Calcium Disodium (Calcium Disodium Versenate) or when Edetate Disodium was used for "chelation therapies" and other uses that are not approved by the FDA. As a result, FDA is reviewing the benefit/risk profile of Edetate Disodium to determine if the benefits for its intended use continue to outweigh the serious risks.

These two drugs have very similar names and are commonly referred to only as “EDTA.” As a result, the two products are easily mistaken for each other when prescribing, dispensing, and administering them. Edetate Disodium and Edetate Calcium Disodium work by binding with heavy metals or minerals in the body allowing them to be passed out of the body through the urine.

The FDA originally approved the two drugs for very specific and very different purposes as described below.

Over time, a number of uses that are not FDA approved for these products have evolved in clinical settings. Among these uses are the removal of other heavy metals from the blood and the treatment of heart disease (coronary artery disease), commonly referred to “chelation therapies.”

On March 3, 2006, the Centers for Disease Control and Prevention published an article in the Morbidity and Mortality Weekly Report documenting the deaths of people given Edetate Disodium instead of Edetate Calcium Disodium. FDA was informed early in 2007 of an additional child’s death as a result of a mix-up between the two drugs. Because of the potential for these medication errors to be fatal, the CDC recommended that hospitals evaluate their need to keep Edetate Disodium stocked in their pharmacies. FDA supports this recommendation as a means of reducing the risk of confusing the two drugs.

FDA is issuing this advisory to highlight the following important safety considerations until the ongoing evaluation of the risks and benefits of Edetate Disodium is complete.

FDA will determine further regulatory actions once we complete our evaluation of the safety and efficacy of Edetate Disodium.

The FDA asks healthcare professionals and patients to report serious side effects that may be associated with the use of Disodium Edetate and Edetate Calcium Disodium to the FDA through the MedWatch program by phone (1-800-FDA-1088) or by the Internet at http://www.fda.gov/medwatch. Adverse reactions or quality problems experienced with the use of this Product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This information reflects FDA’s current analysis of data available concerning this drug.
FDA intends to update this when additional information or analyses become available.

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This article was posted on January 17, 2008.

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