Edetate Disodium (marketed as Endrate and generic products) - Overview
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Welcome to the Food and Drug Administration's drug safety update.
I am Pat Clarke from F-D-A's Center for Drug Evaluation and Research.
On January 16, 2008 we issued a public health advisory titled: Edetate Disodium, marketed as Endrate and generic products.
There have been cases where children and adults have died when they were mistakenly given Edetate Disodium instead of Edetate Calcium Disodium, also known as Calcium Disodium Versenate or when Edetate Disodium was used for "chelation therapies" and other uses that are not approved by the FDA.
FDA has not approved Edetate Disodium or Edetate Calcium Disodium for any other uses, such as the removal of heavy metals from the blood and the treatment of heart disease, specifically coronary artery disease, commonly referred to as "chelation therapies."
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. Because of these safety concerns, 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.
FDA is issuing this advisory to highlight important safety considerations for hospitals, pharmacies and healthcare providers until the ongoing evaluation of the risks and benefits of Edetate Disodium is complete.
FDA will determine further regulatory actions such as labeling changes or continued marketing of the drug once we complete our evaluation of the safety and efficacy of Edetate Disodium.
To hear the full public health advisory, listen to part two of this broadcast.
We urge healthcare providers and patients to report serious side effects that may be associated with the use of Disodium Edetate and Edetate Calcium Disodium to us at the FDA's MedWatch adverse event reporting program by phone at 1-800-F-D-A-ten-88 or by the Internet at F-D-A dot GOV slash M-E-D-W-A-T-C-H.
Date created: January 18, 2008