Stevens-Johnson Syndrome is a auto-immune disease that is very rare and often fatal. The disease causes lesions in the mouth, eyes, and body. Arava has been linked to twelve cases of Stevens-Johnson Syndrome.
Stevens-Johnson syndrome is a complex immune disorder that arises from a mediated hypersensitivity complex to certain drugs and chemicals. The Syndrome is a from of allergic reaction and has very serious effects often leading death. The drug Arava has been linked to an unusally large number of cases, although many drugs can lead to this syndrome, lawyers believe the frequentcy of its occurance may mean the drug was not adequately tested.
Arava is used to treat rheumatoid arthritis, has also been linked to several deaths from liver failure. Rheumatoid arthritis is an auto-immune disease in which a patient's own immune system attacks their joint cartilage, about 2 million Americans suffer from the disease. The disease can be debilitating and extremely painful. Arava was created as an alternative to the main treatment for rheumatoid arthritis, the drug methotrexate which suppresses the immune system limiting joint destruction. When it was approved in 1998, the FDA itself said Arava was no more effective methotrexate.
In March 2002, a public advocacy group called Public Citizen asked the Food and Drug Administration 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 the 12 deaths. Two of the deaths were reportedly young patients in their 20's.
Since 1998, there have been over 1.5 million prescriptions written for Arava in the US. Lawyers believe the drug may be too dangerous. Studies have shown that Arava is associated with as many as six times more cases of fatal liver damage than the more widely prescribed arthritis drug methotrexate.
In Europe, the Agency for the Evaluation of Medical Products warned both doctors and patients, about the dangers of Arava in causing liver damage citing nine deaths from liver failure in patients taking Arava. Aventis Pharma, the drug maker sent a warning letter to doctors and the American College of Rheumatology also warned doctors and patients, to have monthly blood during the first six months using the drug, along with follow-up testing every two to three months.
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