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Biotech / Medical : Regeneron Pharmaceuticals
REGN 657.80+1.7%Nov 7 9:30 AM EST

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To: Miljenko Zuanic who wrote (743)2/12/2003 7:13:16 PM
From: keokalani'nui  Read Replies (2) of 3557
 
Combining Anakinra and Etanercept Raises Infection Risk

By Richard Woodman

LONDON (Reuters Health) Feb 06 - The European Medicines Evaluation Agency has warned of an increased risk of serious infection and neutropenia in patients treated concurrently with the arthritis drugs anakinra (Kineret; Amgen) and etanercept (Enbrel; Wyeth and Amgen).

In a statement, it said results of a clinical trial sponsored by Amgen showed that 7% of rheumatoid arthritis patients who received both medications at the same time had developed serious infections. Two percent of patients also developed neutropenia.

A special warning has now been added to the label of both drugs saying that concurrent administration is not recommended because of the increased risk.

The purpose of the trial, which involved 242 patients, was to compare the efficacy and safety of Enbrel 25 mg biweekly alone with Enbrel plus Kineret 100 mg daily.

The incidence of infection and of neutropenia was higher in the combination arm and there was no therapeutic advantage, the EMEA said.

Last month, the EMEA advised physicians to "use caution" when prescribing Enbrel in patients with congestive heart failure because of the possibility that the therapy might worsen their condition.
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