Arava (leflunomide) is a prescription arthritis medication designed to treat rheumatoid arthritis. Classified as a disease-modifying anti-inflammatory drug, Arava prevents painful inflammation by inhibiting the formation of the cells that cause it. But while the drug has been known to work wonders in some patients, Arava is known to cause serious side effects and even death.
What’s the problem?
On March 28, 2002, the consumer advocacy group Public Citizen petitioned the FDA for the removal of Arava. The petition 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.”
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 drug-induced hypertension.”
Public Citizen’s petition followed the February 2001 European Agency for the Evaluation of Medical Products warning issued to doctors and patients citing nine liver failure deaths in Arava patients. Two months following, Arava manufacturer Aventis Pharmaceuticals issued a warning letter to physicians. The American College of Rheumatology then published a warning to doctors and patients urging a monthly blood test be performed in an Arava patient’s first six months with follow up tests every two to three months after.
The resulting deaths and serious Arava side effects associated to the rheumatoid arthritis drug appears to have had warning that may have prevented these incidents from occurring. In February 2001, the European Medicines Evaluation Agency warned of severe liver reactions with some fatal outcomes occurring in Arava patients. The agency said a total of 296 liver reactions had been reported by that time with 129 cases considered serious and nine having a fatal outcome.