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U.S. Department of Health and Human Services

Drugs

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Information on Edetate Disodium (marketed as Endrate and generic products)

FDA has issued a public health advisory to alert patients and healthcare professionals about important 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.