Manufacturer: Sanofi Aventis
Date approved: September 10, 1998
Status: Prescription Only with Black Box Warning
Approved uses: Rheumatoid Arthritis
Off-Label uses: Other types of arthritis
• Severe Liver Damage
• Fatal Liver Failure
• Liver Transplants
Related topics: Unsafe Drugs, Rheumatoid Arthritis
Arava and Severe Liver Damage
Arava is a a disease-modifying anti-rheumatic drug, or DMARD, used to treat rheumatoid arthritis. In July 2010, a “Black Box” warning was added to Arava because of reports indicating severe liver damage resulting in liver transplants or even death.
A Black Box warning is the strictest warning the U.S. Food and Drug Administration can give to a medication. Arava received the warning after 49 reports of severe liver damage, 14 of which resulted in death, were reported between August 2002 and May 2009. Although liver damage has been listed as side effect of the medication since 2003, the Black Box warning will require additional information to be provided to the patient.
Patients with pre-existing liver disease or patients who are taking other medications known to cause liver damage are more at risk of developing severe liver damage while take Arava. Those who have experienced a liver transplant or have passed away due to liver failure are encouraged to submit their case for a FREE legal consult with a LegalView Arava attorney.