7-Jun-10 8:00 AM  CST  

New FDA Warnings on Asthma Medications Now in Effect 

The FDA’s new warnings for the use of long-acting beta-agonist (LABA) asthma medications officially went into effect last week.

Manufacturers of LABAs are now required to attach additional warning labels and recommendations regarding the use of LABAs in asthma and chronic obstructive pulmonary disease (COPD) patients. The agency is also adopting a risk evaluation and minimization strategy (REMS) to ensure that only patients who truly need LABAs should be allowed to use them. Under the new FDA guidelines:

• Single-ingredient LABAs should only be used in combination with an asthma controller medication; they should not be used alone.
• LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications.
• LABAs should be used for the shortest amount time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved. Patients should then be maintained on an asthma controller medication.
• Children who need a LABA in addition to their inhaled corticosteroid to control asthma should use a combination product containing both a corticosteroid and a LABA.

The FDA began looking into the safety of LABAs after the release of the Salmeterol Multi-center Asthma Research Trial (SMART) by GlaxoSmithKline, which manufactures salmeterol, back in 2003. According to the trial results, patients receiving salmeterol were at an increased risk for asthma-related death compared to patients receiving a placebo. After years of researching and data analysis, the FDA made its final recommendations on the usage of LABAs in February of this year. The agency also ordered LABA manufacturers to conduct studies on the risk associated with LABAs when used in combination with an asthma controller medication.

LABAs are prescribed to treat moderate to severe persistent asthma and COPD. They are usually available by themselves or in a combination with corticosteroids, which treat lung inflammation. The most commonly-prescribed single-ingredient LABAs include Serevent (salmeterol), manufactured by GlaxoSmithKline, and Foradil (formoterol fumarate), manufactured by Novartis. The most commonly-prescribed combination corticosteroid and LABA medications include GlaxoSmithKline’s Advair (fluticasone propionate) and AstraZeneca's Symbicort (budesonide and formoterol).

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Source: NPTANews

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