FDA updates Arava label to include sterner liver safety warning
This article was originally published in Scrip
The US FDA is updating the black box warning on Sanofi-Aventis's rheumatoid arthritis drug Arava (leflunomide) to highlight the risk of severe liver injury in patients taking the drug. Arava already has a black box warning noting that the drug cannot be used in pregnant women due to risk of causing fetal harm. It also has a bolded warning, added in 2003, about the risk of liver injury.