Canada’s medicines regulator has issued a safety warning related to Boehringer Ingelheim’s idiopathic pulmonary fibrosis (IPF) therapy Ofev (nintedanib).
Health Canada’s notification to healthcare professionals warns that drug-induced liver injuries (DILIs), including one fatality, have been reported in patients treated with the drug.
Worldwide, the regulator says that over 30 cases of DILI have been reported, and in most cases, the event was resolved when the dose was reduced or treatment was stopped.
The label for the therapy will be updated to include details of the adverse events and recommendations for practitioners to monitor liver transaminases and bilirubin levels before, during and after treatment.
Boehringer’s therapy was approved in the USA in late 2014, and in the EU in early 2015. In 2016, the product generated sales of 600 million euros ($730 million) for the privately held firm, double the revenue from the previous year.