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Arava is manufactured and sold by Sanofi-Aventis. Its underlying drug, leflunomide, is designed to manage the symptoms of rheumatoid arthritis. Arava was approved by the FDA in 1998 for the treatment of rheumatoid arthritis.

While Arava has shown to be effective in managing rheumatoid arthritis symptoms, it also has been connected to an alarming number of severe liver injuries.

Patients Have Been Diagnosed with These Side Effects After Taking Arava

  • Liver injuries, including liver failure that can be fatal
  • Stevens-Johnson Syndrome (a severe and potentially fatal autoimmune disease)
  • Hypertension

In 2002, the consumer watchdog group Public Citizen, petitioned to remove Arava from U.S. markets in response to the following findings in multiple studies:

  • Arava is not as effective as alternative drugs on the market.
  • Arava is significantly less safe than existing competitive drugs.
  • Arava is linked to an alarming number of severe injuries.
  • Certain studies establishing the safety of Arava were poorly conducted.

The petition sets forth the increased risk that Arava presents over a close competitor, methotrexate. In the first three years of Arava being on the market (Sept. 1998 to Sept. 2001), there were 12 cases of leflunomide patients with liver toxicity fatalities (in comparison, two liver toxicity fatalities occurred in methotrexate patients), 38 patients who experienced hypertension (three cases occurred in methotrexate users), and 12 cases of Stevens-Johnson Syndrome (0 cases were observed in methotrexate patients). These increased occurrences were not the result of increased prescription numbers. In fact, during that time period, methotrexate prescriptions outnumbered leflunomide prescriptions by a factor of 5.5 to 1.

In 2009, the FDA conducted a review of leflunomide's connection to severe liver damage and found that an additional 14 deaths resulting from liver failure had occurred in patients taking Arava between 2002 and 2009. This led the FDA to require the addition of a boxed warning for severe liver injury in 2010.

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