Arava May Cause Liver Problems
May 15, 2001
The European Medicines Evaluation Agency (EMEA) reported recently that an alarming number of people who take the arthritis drug Arava are becoming afflicted with various liver maladies. The EMEA cited 296 cases of adverse liver reactions in Arava patients. Arava, also known as leflunomide, is manufactured by Aventis Pharmaceuticals. The EMEA said that of the 296 reported cases, "129 were considered as serious, including two cases of liver cirrhosis and 15 cases of liver failure, nine with a fatal outcome." The EMEA continued, saying that "although confounding factors were present in many cases, a causal relationship to leflunomide cannot be excluded."
Health agencies have known about Arava's ability to negatively impact the liver in patients who have preexisting poor liver health. However, these new reports of liver problems appear to have surprised the European health agency. Arava reduces arthritis pain by impeding the development of immune cells that are the cause of rheumatoid arthritis. The EMEA says that most liver problems associated with Arava occurred within 6 months of taking the drug.
Arava'a manufacturer is sending notification of the new findings to doctors throughout Europe. At this time it is unclear whether Aventis will do the same in the United States. Arava was approved by the FDA for use in the United States in September 1998. Since that time approximately 200,000 Americans have taken Arava. A spokesman for Aventis stressed that authorities have not confirmed the connection between Arava and liver problems. The company notes that many of the reports came from Arava patients who had a history of liver problems. However, the spokesman reiterated the need for patients on Arava to be screened closely before taking the medication and to partake in frequent liver testing while on Arava.
-- Article Courtesy of InjuryBoard.com
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