Drug-Induced Liver Injury Warning Added To OFEV Label In Canada As Done Earlier In US

This Relatively New Idiopathic Pulmonary Fibrosis (IPF) Pill Is Clearly On The Radar Of Drug Safety Regulators   (Posted by Tom Lamb at DrugInjuryWatch.com)   OFEV (nintedanib) capsules were approved by the FDA in 2014 for treatment of idiopathic pulmonary fibrosis (IPF). Boehringer Ingelheim Pharmaceuticals, Inc. is the drug company responsible for OFEV in the US. On January 11, 2018 Health Canada issued a Dear Healthcare Professional Letter communication titled "OFEV (nintedanib) – Risk of Drug-Induced Liver Injury and the Need for Regular Monitoring of Liver Function". From the Background Information section of that new Health Canada document we get this overview of the safety issue: OFEV (nintedanib) is used to treat idiopathic pulmonary fibrosis (IPF). Cases of [drug-induced liver injury (DILI)] have been observed with OFEV treatment in the post-marketing setting since the product was launched in 2014. The overall cumulative [idiopathic pulmonary…

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