Arava - Leflunomide

Arava, also known as leflunomide, is a drug used to treat arthritis. Arava is manufactured by Aventis Pharmaceuticals and was approved by the FDA in September 1998. Arava works by stopping the development of immune cells that cause inflammation, swelling, stiffness, and joint pain.

Recent reports have raised concerns over Arava's safety. European health officials reported that over 200 Arava patients have suffered liver problems after taking the drug. Many of the patients suffered liver failure requiring transplantation and some have died. Recently, the drug was linked to several cases of Stevens-Johnson syndrome. United States health officials are in the process of determining what action, if any, to take in this country.

In November 2003, Aventis Pharmaceuticals and FDA updated the prescribing information for Arava. In postmarketing experience worldwide, rare, serious hepatic injury, including cases with fatal outcome, have been reported during treatment with Arava. Most cases occurred within 6 months of therapy and in a setting of multiple risk factors for hepatotoxicity. Rare postmarketing reports of severe infections, including sepsis, which may be fatal, were also received. Most of the reports were confounded by concomitant immunosuppressant therapy and/or comorbid illness, which, in addition to rheumatoid disease, may predispose patients to infection.

In January 2004, Aventis announced that five people in Japan died after using Arava. According to the pharmaceutical company, 16 patients developed interstitial pneumonia after taking the medication. Five subsequently died. Aventis is advising physicians to not prescribe Arava to patients with respiratory problems.

See your doctor if you have experienced serious side effects associated with Arava. In addition, it may be important to contact an attorney who can help you protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit.

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