A sharply divided FDA advisory committee votes today on whether to restrict long-acting asthma meds. At yesterday's meeting, the expert panel split on the safety of the drugs--Advair, Symbicort, Serevent and Foradil--just as FDA officials had in advance of the gathering.
As you know, some FDA officials recommended against using the drugs, known as long-acting beta agonists, in asthma patients--especially children--because they may offer few benefits over steroid treatment. Others believe that while the meds do carry risks, so do the albuterol inhalers that probably would be used more often without the LABA drugs.
As the New York Times notes, 6 million people are treated annually with these meds, the most popular of which is Advair, made by GlaxoSmithKline; its sales may approach $8 billion this year. About half of those using LABA meds are asthma patients; the other half suffer from COPD.
Some of the advisory committee members said that they didn't have enough data to make a decision on the drugs, and the disagreement within the FDA wasn't doing them any favors, either. Safety officials think the LABA-only drugs Serevent and Foradil shouldn't be used for asthma any longer and that the LABA/steroid combos Advair and Symbicort restricted in kids 17 and younger. But the respiratory drug office thinks doctor and patient education would be a better choice. We'll see how the panel votes later today.
- read the AP story
- check out the New York Times coverage