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U.S. Department of Health and Human Services

Safety

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Advair Diskus (fluticasone propionate & salmeterol inhalation powder)

Audience: Pulmonologists, other healthcare professionals and consumers

[Posted 11/18/2005] 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.

[November 18, 2005 - Public Health Advisory - FDA]
[November 18, 2005 - Drug Information Page - FDA]