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 fibrosis (IPF)] patient exposure to OFEV from marketing experience is estimated to be over 32,000 patient-years. As of October 15, 2017, 32 cases of DILI have been reported worldwide in patients treated with OFEV, including one in Canada. In 24 of the 32 cases, the outcome of the DILI events was reported. In the majority (17) of these cases, the DILI event resolved when the dose was reduced or treatment was stopped. In 6 cases, the patient had not recovered at the time of reporting. One case resulted in fatal outcome.
That document went on to state “Health Canada is working with the manufacturer to update the Canadian Product Monograph [for OFEV] with this safety information.”
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.
We will continue monitor the medical literature and the drug safety regulators for further developments regarding this drug-induced liver injury issue for OLEV.[Read article in full at original source]