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Re: Fw: Enbrel & Infection Potential REPLY

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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.

>>

>>

>>

>> -------------------------------------------------------------------------

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>>

>>

>>

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