Hepatotoxicity: 35 Drug Products Require New Warnings

Peter Wetherall

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The FDA recently posted a list of 35 drugs that required safety labeling changes. Readers know recent blogs discuss several unsafe drugs, such as Reglan, and the inadequacies in the warning labels. The FDA identified several drugs that had to have "boxed" warnings (the strongest warning). One of the boxed warnings applied to Tykerb (also known as lapatinib) which causes Hepatotoxicity. A boxed warning also applied to a well known drug, Strattera. This boxed warning will strong warn against the risk of suicide if given to children. See a complete listing of the 35 drugs