Question- What is the most common reason for withdrawing drugs from the market and for “black box” warnings by the U.S. Food and Drug Administration (FDA)?
Answer- Drug induced liver injury (DILI) is the most common reason for withdrawing drugs from the market and for “black box” warnings by the U.S. FDA. (Reuben A, et al. Acute Liver Failure Study Group. Drug-induced acute liver failure: results of a U.S. multicenter, prospective study. 2010 Hepatology 52(6):2065–2076 and Bleibel W, et al. Drug-induced liver injury: review article. 2007 Dig Dis Sci 52(10):2463–2471)
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