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New Boxed Warning on Enbrel® Label Regarding Infections
Source: The Food and Drug Administration Enbrel®, an injectable medicine used for the treatment of rheumatoid arthritis in adults and children, has a new boxed warning to include risks of serious infections, such as tuberculosis, leading to hospitalization or death. The medicine is also used to treat psoriatic arthritis, ankylosing spondylitis, and psoriasis. The adverse reactions section of the Enbrel® label has also been updated to include information regarding global clinical studies and the rate of occurrence of tuberculosis in patients treated with Enbrel®. Health care professionals should screen patients for latent tuberculosis infection before beginning Enbrel®. Patients should be educated about the symptoms of infection and closely monitored for signs and symptoms of infection during and after treatment with the drug. Patients who develop an infection should be evaluated for appropriate antimicrobial treatment and, in patients who develop a serious infection, Enbrel® should be discontinued. Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's "Dear Healthcare Professional Letter" regarding this issue at: |
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