Arava is a prescription drug for rheumatoid arthritis that has recently been linked to 130 cases of severe liver problems (hepatoxicity) and up to 22 deaths since it has been on the market. Arava is manufactured by Aventis Pharmaceuticals and is also known as leflunomide.
What’s the problem?
Manufactured by Aventis Pharmaceuticals, Arava gained FDA approval on September 11, 1998. Since it’s approval, Arava has been prescribed to more 2 million people who have rheumatoid arthritis. A profitable drug for Aventis, Arava made $225 million in worldwide sales in 2001 alone.
The approval of Arava has been controversial due to the reported dangers associated to the drug and its inability to treat rheumatoid arthritis sufferers any better than previous methods. The death rate is 33 times higher when using Arava than when using methotrexate. In addition to the deaths and high number of liver problems linked to Arava, the life-threatening autoimmune disease Stevens-Johnson syndrome has been reported in Arava users.
In March 2002, the public advocacy group, Public Citizen asked the FDA to withdraw Arava. The group cited reports already made to the FDA about Arava’s association with about 130 cases of severe liver toxicity, which included 56 hospitalizations and 12 deaths. Two of the deaths were reportedly young patients in there 20’s. In 2002, worldwide sales of Arava totaled close to $322 million. On November 21, 2003, the FDA warned doctors that the use of Arava could, in rare cases, seriously damage the liver.
From Arava’s arrival on the market, there have been studies showing the adverse effects that can occur in Arava patients. In addition, Arava is not viewed as having any superiority over other rheumatoid arthritis prescriptions – it simply provided patients “more options.”