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http://www.nlm.nih.gov/medlineplus/news/fullstory_11166.html

 

 

 

Enbrel Arthritis Drug May Worsen Heart Failure

Reuters Health

 

By Richard Woodman

 

Wednesday, January 8, 2003

 

 

 

LONDON (Reuters Health) - Physicians are being advised to " use caution " when

using Wyeth and Amgen's arthritis drug Enbrel (etanercept) in patients with

congestive heart failure because of the possibility that the therapy may worsen

their condition.

 

An updated European summary of product characteristics says: " There have been

postmarketing reports of worsening of congestive heart failure, with and without

identifiable precipitating factors, in patients taking Enbrel. "

 

Congestive heart failure (CHF) is a chronic condition in which the heart loses

its ability to pump blood efficiently. The disease causes fatigue and shortness

of breath as fluid accumulates in the lungs and tissues.

 

" Two large clinical trials evaluating the use of Enbrel in the treatment of CHF

were terminated early due to lack of efficacy. Although not conclusive, data

from one of these trials suggest a possible tendency toward worsening CHF in

those patients assigned to Enbrel treatment. "

 

The drug label says allergic reactions are not uncommon.

 

" In postmarketing experience, allergic reactions have included angioedema

(swelling in the deep layers of the skin) and urticaria (hives) as well as

serious reactions. If any serious allergic or anaphylactic reaction occurs,

Enbrel therapy should be discontinued immediately and appropriate therapy

initiated. "

 

It also notes that sepsis and serious infections have been reported and advises

that " administration of Enbrel should be discontinued if a patient develops a

serious infection. "

 

 

 

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