Arava manufactured by Aventis Pharmaceuticals gained FDA approval on September 11, 1998. Since it’s approval Arava has been prescribed to more 2 million people who have Rheumatoid Arthritis. 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 the 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 seriously damage the liver.
Arava Linked With SJS
In addition Arava has been linked with Stevens Johnson Syndrome (SJS). Stevens Johnson Syndrome (SJS) is a type of skin disease that can cause rash, skin peeling, and sores on the mucous membranes. Stevens Johnson Syndrome (SJS) is an immune-complex–mediated hypersensitivity disorder that may be caused by many drugs, viral infections, and malignancies. Often, the drugs causing the onset of Stevens Johnson Syndrome (SJS), did not have warnings placed on their labels until recently.
Patients unknowingly took these drugs and many developed the potentially fatal Stevens Johnson Syndrome (SJS). With Stevens Johnson Syndrome (SJS), a person has blistering of mucous membranes, typically in the mouth, eyes, and vagina, and patchy areas of rash.