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drug_recall aravaAccording to a consumer advocacy group, over 130 reports have been filed with the FDA linking Arava and liver failure, liver damage, and numerous other complications. Arava, also known as leflunomide, is a prescription drug manufactured by Aventis Pharma to treat the physical signs of rheumatoid arthritis. Arava works by inhibiting the enzyme dihydro-orotate dehydrogenase (DHODH), a part of the immune system responsible for some of the painful symptoms of rheumatoid arthritis, including swelling, stiffness, and joint pain. Arava was originally introduced in 1998 as a safer alternative to methotrexate, but has had a death rate of up to 33 times greater and six times the number of reports of liver damage.
The relationship between Arava and liver failure is complicated by the buildup of the drug in liver tissue. Warnings currently appear on the packaging, noting that the drug can remain in body tissue for up to months at a time, meaning that damage may continue long after the patient ceases to take the medication. There is a drug elimination procedure, but without completing it, patients can show significant levels of Arava for up to two years after cessation. Because of the high number of cases demonstrating connections between the use of Arava and liver failure, doctors are now required to conduct liver tests every month to monitor the effects of the drug. Even with this testing, there is virtually no way to predict who will suffer from the side effects of Arava, and liver damage-should it occur-would be heightened due to the amount of time it takes to remove the drug from the patient''s system.
According to Dr. Sidney Wolfe, director of Public Citizen''s Health Research Group, the FDA holds responsibility for removing this dangerous drug from the market, now that the connection between Arava and liver failure is indisputable. "Before it was approved by the FDA, there was evidence that leflunomide led to liver complications, and now the dangers are even clearer," Wolfe said. "No more patients should be subjected to these risks."
When FDA medical reviewer David Graham told lawmakers during a congressional hearing on the recall of Vioxx that drugs require stricter safety evaluations, he didn''t stop there. Graham named five other drugs currently on the market that he belie...