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. |
