ARAVA®
Arava® is the trade name used by Aventis Pharmaceuticals for leflunomide, a new class of drug prescribed for sufferers of rheumatoid arthritis (RA), a disease that affects an estimated 2 million people, 70 percent of whom are women. This condition involves inflammation in the lining of the joints and/or other internal organs and can typically affect many different joints. RA can be chronic, which means it lasts a long time, or it can be a disease of flares (active) and remissions (little to no activity).
The liver converts the active ingredient in Arava®, leflunomide, into a new chemical that inhibits the spread of diseases that affect the autoimmune system, such as rheumatoid arthritis. Although a new class of drug, Arava's success rate is no better than other drugs already prescribed to treat the symptoms of RA, therefore the risks of taking Arava® may outweigh any potential benefit.
So far the FDA has taken no action in regard to Arava® despite some 130 reports of severe liver reactions in people taking Arava®, including 12 cases in which fatalities occurred. In addition, Arava® has been linked to five deaths in Japan due to interstitial pneumonia or lung problems.
Public Citizen, a victim's advocacy group, has asked that the FDA remove Arava® from the market because of its association with liver disease and other problems, especially because another drug, methotrexate, treats the same symptoms with fewer serious reactions.
One possible such reaction is Stevens-Johnson Syndrome. This is a rare, severe, and sometimes fatal form of auto-immune disease. Symptoms include lesions in the mouth and eyes, headache, fever, fatigue, and conjunctivitis. In severe cases, the skin will blister and eventually slough off. Twelve cases of Stevens-Johnson Syndrome have been reported in Arava® patients. No such case has been associated in patients taking the alternative drug, methotrexate.
WHAT TO DO NEXT
Liver tests are necessary while taking Arava® to monitor for elevated liver enzymes. If you have elevated enzymes, or have symptoms similar to Stevens-Johnson Syndrome (such as lesions, headache and fever) you should consult a physician and contact the attorneys at Van Laningham & Associates. We are currently investigating these cases and will evaluate your case at no charge.
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