There have been many reports suggesting Arava being responsible for severe liver damages. These revelations led public interest group Public Citizen to submit a petition to the U.S. Food and Drug Administration (FDA) on March 28, 2002. This petition requested recall of Arava which belongs to a class of drugs known as disease modifying anti-rheumatic drug or DMARD.

The petition led several law groups such as the Kahn Gauthier Law Group to investigate possible lawsuits against Aventis Pharmaceuticals Inc. Aventis is manufacturer of Arava. Many reports suggested that a large number of patients have suffered liver damage due to use of Arava.

Arava was approved by the U.S. Food and Drug Administration FDA on September 11, 1998 for the treatment of active rheumatoid arthritis in adults. It is manufactured by Aventis pharmaceuticals. Rheumatoid arthritis is a chronic autoimmune disease. In this disease patient can suffer deformity or permanent disability. Most of rheumatoid arthritis patients are women.

Arava is brand name for leflunomide. It is used for treatment of rheumatoid arthritis. It reduces damage on bone joints and improves physical functioning. It reduces signs and symptoms of rheumatoid arthritis. It also improves physical function and prevents the development of structural damage to the joints. It blocks the certain enzymes, which causes abnormal tissue development or growth. Through this it checks arthritis.

FDA also asked Aventis to add a black box warning on the arthritis drug Arava regarding liver damages after many reports suggested so. It also notified patients and healthcare professionals about it. This warning was the result of a FDA review of the side effects of Arava reported between August 2002 and May 2009. FDA drug reviewers said that Arava could produce itching, yellow eyes or skin, dark urine, loss of appetite or light-colored stools as symptoms of liver damage.

The FDA identified almost 49 cases of severe liver injury arising from use of Arava, including 14 fatalities. The most commonly reported side-effect was jaundice, but some patients also reported blood-clotting problems such as encephalopathy and coagulopathy. The FDA had determined that those patients who had pre-existing liver problems and those who were taking other drugs which causes increased riskĀ of liver injury were at most risk.

These events led to several lawsuits against Aventis pharmaceuticals related to side effects of Arava. Possibilities of a class action suit against Arava side effects are also likely. This is being touted as a better option to save many patients, who had suffered from Arava side effects and are interested in filing a suit against Aventis, from hassles of legal proceedings. A class action can be beneficial, for all the similar cases, as all of them will get same compensation as the representative case of the class. It will save time as well as money. All the plaintiffs would also be able to avail expertise of many attorneys representing cases in the class. It will also save from possibility of contrary verdicts. As number of lawsuits against Arava is rising, a class action lawsuit is possible in near future.