Healio
Healio
February 18, 2010
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FDA recommends label change for certain long-acting beta agonists

Certain long-acting beta agonists will now carry labels advising that these products should always be used in combination with another against asthma controller medication, FDA officials announced today.

The FDA said in a press release that the recommendations apply to single-agent drugs Serevent (Glaxo Group Limited) and Foradil (Novartis) as well as combination medications Advair (GlaxoSmithKline) and Symbicort (AstraZeneca).

In the statement, the FDA advised:

  • Long-acting beta agonists (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 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.
  • Pediatric and adolescent patients who require LABA in addition to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA to ensure compliance with both medications.

The FDA based the changes on data from three clinical trials: the Salmeterol Multi-Center Asthma Research Trial (SMART), the Salmeterol Nationwide Surveillance study (SNS) and a meta-analysis conducted by the FDA in 2008. Results from the three trials linked the use of LABAs with potential worsening asthma symptoms, hospitalization in both children and adults and death in some patients with asthma.

Despite the new safety warnings, the FDA noted that appropriate use of LABAs can be beneficial in the treatment of asthma.

“We will collaborate with our Safe Use partners to evaluate whether prescribing patterns adjust to the new recommendations for this class of asthma drugs. If prescribing patterns don’t adjust, we will determine the reason and consider additional steps to support safe prescribing,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a press release.

FDA officials are asking for more studies to further evaluate the safety of these drugs.