Warning of bacterial sepsis and tuberculosis added to etanercept prescribing information

May 5, 2008

FDA alerts clinicians to serious infections associated with the use of Enbrel

The manufacturers of etanercept (Enbrel, Amgen/Wyeth), in coordination with the Food & Drug Administration, have updated the product’s prescribing information to warn healthcare professionals of the potential for serious infections while receiving the therapy. Both bacterial sepsis and tuberculosis are among the serious infections reported. The update will include information from global clinical studies and the rate of occurrence of tuberculosis while being treated with the therapy. Clinicians are advised to screen patients for latent tuberculosis prior to initiating therapy and monitor for signs of infection during treatment. Etanercept should be discontinued in patients who develop a serious infection. The Dear Healthcare Professional Letter can be accessed on the FDA Web site.

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