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Risk of Serious Liver Injury for Patients Taking Arava Prompts a New Boxed Warning
by admin on: March 18th, 2011

Arava, also known by the generic name Leflunomide, is a drug indicated to treat adults diagnosed with rheumatoid arthritis. This product may reduce the signs and symptoms of arthritis and may block the structural damage that can occur???as demonstrated by x-ray erosions???and may improve the physical functioning of the joints. This drug, when previously approved by the U.S. Food and Drug Administration (FDA), was contraindicated in patients who were pregnant, and women having childbearing potential but who were not using reliable contraception.

In 2003, a bolded warning was added to the drug label for Arava (Leflunomide), stating this drug could result in severe liver injury, although in 2010; FDA came to a decision that this warning should be added to the box of this product. The reason for this additional warning is that the number of adverse reports the FDA received regarding the use of this drug had reached a critical mass, whereby the FDA felt stronger warnings needed to be included. For example, during the 2010 review of the adverse reports for Arava, between August 2002 and May 2009, there were 49 cases of patients suffering severe liver injury. Of these 49 cases, 14 cases resulted in fatal liver failure. Further drilling down the data from these cases revealed that the patients who had the greatest risk for severe liver injury were patients who were already taking other drugs known to result in liver injury and patients who presented with pre-existing forms of liver disease.

It is hoped that the increased level of awareness for Arava will reduce the number of adverse events associated with the use of the product. Health care professionals should be extra cautious when prescribing this drug, and patients should be aware of the potential for adverse effects as well as symptoms associated with liver disease, should they be placed on this medication.

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