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Safety Requirements for Advair and Other Asthma Medications Changed

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Rockville, MDThe FDA has announced that it is changing the safety requirements for asthma medications, including Advair. The affected medications are Long-Acting Beta-Agonists (LABAs) sold as single-ingredient products (Serevent and Foradil) and as an ingredient in products that contain inhaled corticosteroids (Advair and Symbicort). These medications are used to treat asthma and chronic obstructive pulmonary disease (COPD).

According to an FDA news release on 2/18/10, "These changes are based on FDA's analysis of studies showing an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations in pediatric and adult patients as well as death in some patients using LABAs for treatment of asthma."

The FDA recommends that LABAs be used in combination with an asthma controller medication; LABAs that are single-ingredient should not be used alone; LABAs should only be used long-term in patients whose asthma is not controlled on asthma controller medications; LABAs should be used for the shortest time possible to gain control of asthma symptoms, at which point the LABA should be discontinued if possible; and children who use a LABA should use a combination product that contains an inhaled corticosteroid and a LABA.

The FDA also now requires a Risk Evaluation and Mitigation Strategy (REMS) for LABAs that will include a revised patient Medication Guide and has told manufacturers that additional clinical trials must be held to evaluate the safety of LABAs.

However, some critics argue that the FDA's new safety requirements for LABAs are not only incorrect but also dangerous for people with asthma. Matthew Mintz, a doctor and blogger on wrote on 2/19/10 that the FDA misinterpreted the data it used to determine that the new safety requirements were necessary. According to Mintz, the data that is available suggests that the FDA's safety requirements are not a good idea.

Mintz says that what makes these recommendations dangerous is that some patients will simply stop taking their medications and will suffer because of it, potentially causing more harm than the LABAs themselves. Mintz notes that the FDA's own advisory committee voted 27 to 0 that Advair was safe but the FDA still went ahead with its new safety requirements.



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