Guest guest Posted May 13, 1999 Report Share Posted May 13, 1999 Thank you so much for sharing this article. I am using Enbrel and will take a copy to my rheumy next week. Hugs, Jani >From: " Jolly " <denisej@...> > > >> >> Arthritis drug linked to serious infection >> >> NEW YORK, May 12 (Reuters Health) -- The recently approved arthritis drug, >> etanercept (Enbrel), may increase the chance of potentially >life-threatening >> infections in some patients with rheumatoid arthritis, according to a >> warning issued Wednesday by the Food and Drug Administration (FDA). >> >> The drug, a genetically engineered protein, was approved for the treatment >> of moderate to severe, active rheumatoid arthritis (RA). The FDA notes >that >> the drug ``can significantly reduce pain and swollen joints in people >> disabled with RA.'' But it is also known to suppress tumor necrosis >factor, >> an important infection-fighting protein produced by immune system cells. >> >> Of an estimated 25,000 people given the drug, 30 have developed serious >> infections and 6 have died. Although people with rheumatoid arthritis are >> prone to infections, and many of the patients had a history of chronic >> infections, the deaths occurred within 2 to 16 weeks after starting >> treatment with Enbrel. >> >> This suggests that ``significant concerns remain that Enbrel may >contribute >> to the occurrence of serious infections,'' according to a statement issued >> by the FDA. >> >> The drug's manufacturer, Immunex Corporation (Nasdaq:IMNX - news) of >> Seattle, Washington, along with Wyeth-Ayerst Laboratories in Philadelphia, >> Pennsylvania, is sending a letter to physicians to alert them of the >> potential risks. >> >> Etanercept was approved in November of 1998 for treatment of rheumatoid >> arthritis, an autoimmune disease that usually strikes between the ages of >36 >> and 50 and is characterized by painful inflammation and joint destruction. >> >> At that time, the drug was considered inappropriate for patients with >> sepsis, a widespread blood infection, or those who developed a serious >> infection. >> >> ``Because of new information obtained from adverse reaction reports to FDA >> and Immunex, the warning related to sepsis has been expanded to include >> patients with any active infection, including chronic or localized >> infections,'' according to the FDA. >> >> The agency suggests that doctors use caution in prescribing the drug to >> patients who are free of infection, but have a history of recurrent >> infections, or who have underlying conditions, such as diabetes, that >> increase their infection risk. >> >> >> >> ------------------------------------------------------------------------- - >-- >> ---- >> >> >> > > >------------------------------------------------------------------------ >Where do some of the Internet's largest email lists reside? > >At ONElist - the most scalable and reliable service on the Internet. Quote Link to comment Share on other sites More sharing options...
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