Reuters Health Information (2003-11-21): Aventis warns of liver side effects of Arava drug
Aventis warns of liver side effects of Arava drug
Last Updated: 2003-11-21 15:38:37 -0400 (Reuters Health)
PARIS (Reuters) - France's largest pharmaceuticals company Aventis SA has warned doctors that the use of its rheumatoid arthritis drug Arava (leflunomide) could, in rare cases, seriously damage the liver.
The once-a-day drug is available in 70 countries and was launched in the United States in 1998 and in Europe in 1999.
"In postmarketing experience worldwide, rare, serious hepatic injury, including cases with fatal outcome, have been reported during treatment with Arava," Aventis said in a letter to healthcare professionals in October.
The letter is posted on the Web site of the U.S. Food and Drug Administration.
Aventis said it had updated the prescribing information and monitoring recommendations with the new information.
"The overall safety profile and postmarketing experience with Arava otherwise remain consistent with safety and efficacy demonstrated in our extensive clinical-trial program," Aventis said.