FDA on Asthma: Heavy Breathing

December 22nd, 2008 | Sources: MedPageToday, NY Times


It wasn’t a pretty process, but FDA officials finally agreed to proscribe Serevent and Foradil as treatments for asthma while allowing asthma sufferers to continue using Advair and Symbicort.

The 4 inhalational drugs all contain long-acting beta agonists, but only the latter 2 contain steroids as well. Advair and Serevent are made by GlaxoSmithKline. The former is, at $6.9 billion in annual sales, GSK’s biggest seller.

Symbicort is marketed by AstraZeneca and has annual revenues of about $350 million. Foradil is marketed by Novartis.

All 4 drugs are still OK for use by patients with COPD, according to the FDA.

The FDA’s decision followed a hectic week in which officials openly disagreed about the drugs’ safety after a meta-analysis they commissioned on the subject was found to have methodological flaws rendering the study worthless.

Some physicians believe that long-acting beta agonists can prevent asthma attacks if used properly. The problem is that unless they are used in conjunction with inhaled steroids, they seem to increase the risk of particularly severe attacks.

And a lot of people don’t always use the long-acting beta agonists correctly.

The long-acting drugs are not effective treatment for acute exacerbations of asthma. If people use them for this purpose instead of rescue inhalers (which contain short-acting beta agonists), they delay proper treatment which can lead to unnecessary complications.


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