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Advair Diskus, Foradil Aerolizer, and Serevent Diskus: BEWARE

Posted Jul 22 2009 10:46pm

Via the FDA:

Today, FDA requested 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 medicines belonging to the class known as “long-acting beta 2-adrenergic agonists” (LABA), which are long-acting bronchodilator medicines.

The information in FDA’s proposed changes to the product labels explains that, even though LABAs decrease the number of asthma episodes, these medicines may increase the chances of a severe asthma episode when they do occur. In one asthma medicine study, an increased number of people taking a LABA in addition to their usual asthma care died from their asthma compared to people taking a placebo in addition to their usual asthma care, although the number of asthma deaths in the study was small. The Medication Guide has information about these risks for patients and caregivers in language approved by FDA and will be given to patients when a prescription for a LABA is filled or refilled.

You may find more information at:
http://www.fda.gov/cder/drug/infopage/LABA/default.htm

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