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FDA updates Arava label to include sterner liver safety warning

 
• By Asher Mullard

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.

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.

"The decision to add information on severe liver injury to the Boxed Warning was based on FDA's 2010 review of...

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