FDA Meets With Panel Over Safety of Enbrel, Remicade and Humira
March 4, 2003
The U.S. Food and Drug Administration (FDA) met with a panel of safety regulators Tuesday to discuss three rheumatoid arthritis medications and their link to lymphoma. In December 2002, the FDA and the National Cancer Institute in Maryland revealed that, since 1999, they had received dozens of reports of lymphoma following the administration of Abbott's Humira, Amgen's Enbrel and Johnson and Johnson's Remicade.
FDA officials, who stated that the drugs had a "probable or possible" link to the development of the disorder in these cases, are reportedly seeking advice on how to further study the issue and whether the drugs' labels should be changed. Analysts believe safety regulators will have a difficult time linking the drugs to the cancer because studies have shown patients with rheumatoid arthritis already face a higher risk of lymphoma. Enbrel, Remicade and Humira are expected to generate over $1 billion in sales in 2003.
-- Article Courtesy of InjuryBoard.com
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