Letter to the Editor Published in Clinical Pharmacokinetics: Hepatotoxicity of Alogliptin
Published online on October 22, 2014
Public Citizen criticizes a recent article published in Clinical Pharmacokinetics that concluded that “no hepatotoxicity has been reported” during the development of the diabetes drug alogliptin. However, after analyzing phase 2 and 3 pre-approval trials of alogliptin and post-marketing surveillance data for the drug from Japan, the Food and Drug Administration and European Medicines Agency concluded that the drug’s potential hepatotoxicity warranted inclusion of warning language in the drug’s label.
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