Arava® Liver Injury & Hepatoxicity

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To date, over 130 reports have been filed with the FDA linking Arava to liver injury, liver failure (hepatoxicity), and numerous other complications.

What’s the problem?

Liver failure (hepatoxicity) is a side effect found amongst prescription drugs that has been linked to the use of Arava. Since Arava was approved in 1998, there have been at least 130 reports of severe liver toxicity. The actual number of reported side effects that the FDA receives is estimated to be just 5-10% of the actual number of adverse effects experienced.

The liver plays a central role in transforming and clearing chemicals and is susceptible to the toxicity from these agents. Hepatoxicity generally occurs when a large part of the liver has become damaged beyond repair. Prescription drugs can cause liver failure, and Arava has been reported to have caused 12 deaths due to liver failure. Most instances of liver failure require a liver transplant in order to avoid death. The FDA has six times more reports of Arava liver damage than in methotrexate users despite thousands more people using the older rheumatoid drug.

The relationship between Arava and liver failure is complicated by the buildup of the drug in liver tissue. Warnings currently appear on the packaging, noting that the drug can remain in body tissue for up to months at a time, meaning that damage may continue long after the patient ceases to take the medication. There is a drug elimination procedure, but without completing it, patients can show significant levels of Arava for up to two years after cessation.

Because of the high number of cases demonstrating connections between the use of Arava and liver failure, doctors are now required to conduct liver tests every month to monitor the effects of the drug. Even with this testing, there is virtually no way to predict who will suffer from the side effects of Arava, and liver damage would be heightened due to the amount of time it takes to remove the drug from the patient’s system.

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