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November 18, 2005

FDA ALERT

Subject: FDA MedWatch - Long-acting Beta2-adrenergic Agonists Public Health Advisory

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA notified manufacturers of Advair Diskus, Foradil Aerolizer, and Serevent Diskus to update their existing product labels with new warnings and a Medication Guide for patients to alert health care professionals and patients that these medicines may increase the chance of severe asthma episodes, and death when those episodes occur. All of these products contain long-acting beta2-adrenergic agonists (LABA). Even though LABAs decrease the frequency of asthma episodes, these medicines may make asthma episodes more severe when they occur. A Medication Guide with information about these risks will be given to patients when a prescription for a LABA is filled or refilled.

Read the complete MedWatch 2005 Safety Summary, including links to the FDA Public Health Advisory and the FDA Drug Information Page that includes links to the Healthcare Professional and Patient Information Sheets, at:

http://www.fda.gov/medwatch/safety/2005/safety05.htm#LABA