NEW YORK (Thomson Financial) - Amgen Inc. and Wyeth Monday said they have updated the Food and Drug Administration-approved U.S. prescribing information for arthritis pain medication Enbrel to contain a boxed warning relating to the risk on infections, including tuberculosis.
The prescribing information previously included a bolded warning about the risk of infections. The information is now boxed and includes additional language regarding screening and monitoring patients for tuberculosis, including patients who had tested negative for latent tuberculosis infection.
In addition, the boxed warning states that tuberculosis has been observed in patients receiving TNF-blocking agents, including Enbrel, and that tuberculosis may be due to reactivation of latent tuberculosis infection or to new infection, the company said.
Amgen shares fell 1.5% to $43.80. Wyeth shares rose 1.7% to $40.07. Christie Rizk cr/jw COPYRIGHT Copyright Thomson Financial News Limited 2007. All rights reserved. The copying, republication or redistribution of Thomson Financial News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Financial News.
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