Arava
On March 28, 2002, the consumer advocacy group Public Citizen petitioned the FDA for the removal of Arava from the market. The petition of the FDA states that, from when it was first marketed in late September 1998 through September 2001, Arava has been associated with at least 130 severe hepatic reactions including 56 hospitalizations and 22 deaths, two of whom were patients in their twenties.
Arava (leflunomide) is a prescription drug manufactured by Aventis Pharma for the treatment of rheumatoid arthritis. Since its approval by the U.S. FDA on September 10, 1998, it is estimated that 1.5 million prescriptions for Arava have been filled in the United States.
Public Citizen's analysis of available Arava data "found not only many cases of severe drug-induced hepatotoxicity, but also large numbers of lymphomas as well as other hematologic, gastrointestinal, and skin reactions serious enough to cause hospitalizations and deaths, and a large number of cases of hypertension."
Another danger of the drug is that it remains in the body tissues for an extremely long time. Warning already on its packaging suggests that byproducts could remain in the body for months, so that even if patients stopped taking the drug after an adverse reaction started, the damage could continue to affect patients for months.
Arava has also been linked to Stevens-Johnson Syndrome.
Links with informations about Arava:
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