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FDA updates Arava label to include sterner liver safety warning

This article was originally published in Scrip

Executive Summary

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.

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