Arava News

March 29, 2002

Arava News: Rheumatoid arthritis drug Arava (leflunomide) is linked to at least 12 liver failure deaths.

Public Citizen filed a petition to the FDA urging them to review the unexpected deaths and serious illnesses that have been attributed to the use of Arava (leflunomide). Former FDA scientific adviser Dr. David Yocum supports Public Citizen's petition because "here we have 12 deaths, and these patients died very quickly. All I can say is, this needs to be reviewed."

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. Last August, 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. Yocum said he has never supported taking a drug off the market, "but it's kind of scary, what we see." (MSNbc, 3-29-02)

March 28, 2002

Public Citizen asks FDA to immediately ban Arava.
Consumer advocacy group Public Citizen urged regulators to immediately ban Aventis' rheumatoid arthritis drug Arava (leflunomide) due to the link to 12 fatal cases of liver failure. Public Citizen finds the risks of Arava to outweigh its benefits that have proven to be no more effective or beneficial than older, commonly used treatments.

The FDA has received 130 reports of severe liver problems in Arava patients since the drug's 1998 U.S. debut. Reports of lymphoma and drug induced hypertension in Arava patients, as well as blood and gastrointestinal reactions leading to hospitalizations have been found, according to Public Citizen. Director of Arizona Arthritis Center and former scientific adviser to the FDA, Dr. David Yocum, also agrees that Arava should be pulled from the market. Yocum has treated a patient on Arava that died from liver failure, and he finds Public Citizen's data to be "idiosyncratic and unpredictable".

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. (Reuters, 3-28-02)

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March 28, 2002

Rheumatoid arthritis drug Arava may cause liver damage.
Public Citizen wants rheumatoid arthritis drug Arava banned because of the dozens of serious liver injuries and 12 deaths linked to the drug's use. After the 1998 FDA approval, the FDA did state that Arava worked no better than the older drug, competitor methotrexate, but it know provided patients with different options. The FDA has now received at least 130 reports of severe liver toxicity linked to Arava use, and this includes 56 hospitalizations and 12 deaths. The FDA has six times more reports of liver damage among Arava users than methotrexate users, despite methotrexate being prescribed 5.5 times more than Arava. (Yahoo, 3-28-02)

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