US FDA updates labeling on long-acting beta-agonists, notably GSK's Advair and Serevent and AstraZeneca's Symbicort

The US Food and Drug Administration yesterday announced that long-acting beta-agonists (LABAs), used for the treatment of asthma and chronic obstructive pulmonary disease (COPD), will now have to carry new recommendations in their drug label intended to promote their safe use in the treatment of asthma. The new recommendations do not apply to the use of LABAs for COPD therapy, but cover both single and combination drugs.

Drugs in the LABA class include GlaxoSmithKline's Advair (fluticasone/salmeterol) and Serevent (salmeterol), AstraZeneca's Symbicort (budesonide/formoterol) and Novartis and Merck & Co's Foradil (formoterol). US regulators said that they also sent letters about the labeling changes to Dainippon Sumitomo, which manufactures Brovana (arformoterol), and Mylan, which makes Perforomist (formoterol).

In February this year, the agency announced it was requiring manufacturers to revise their drug labels because of 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 the treatment of asthma (The Pharma Letter February 19).