Reports of liver injuries stemming from the pulmonary fibrosis therapy Ofev (nintedanib), including a fatality, have prompted Health Canada to issue a safety warning about it to medical professionals.
The regulatory agency said 32 cases of Ofev-induced liver injuries due have been reported across the world since its approval in 2014. The majority have occurred in the first three months of treatment, and were resolved with lower doses of Ofev or discontinuation of the treatment.
Health Canada is working with Boehringer Ingelheim, Ofev’s manufacturer, to update the product’s label to warn that it can cause liver injuries. It is also working with the company on recommendations about when healthcare practitioners should check patients’ liver function.