The FDA withdrew approval of one new drug application and two abbreviated new drug applications for edetate disodium injection. The withdrawals were instituted because of medication errors. As noted in an FDA January 16, 2008, Public Health Advisory, children and adults died when mistakenly given edetate disodium instead of edetate calcium disodium or when edetate disodium was used for indications other than those approved by the agency. Edetate disodium is used for the treatment of hypercalcemia and for the control of ventricular arrhythmias associated with digitalis toxicity. The FDA asked Hospira, Apotex, and Bionice to voluntarily remove their products from the market, and all three pharmaceutical companies agreed in writing to the agency's request and waived their opportunity for a hearing.
SOURCE: FDA Notice
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