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FDA Panel Asks: Are Asthma Drugs Safe?

Serevent, Symbicort, Foradil Safety Focus of Triple FDA Panel Meeting


That study, the SMART trial, was ended early when patients taking Serevent turned out to have a small but significant increase in asthma-related deaths compared to patients taking a placebo. This led to the black-box warning on all LABA-containing drugs.

In more recent years, doctors have stressed the use of either the combination inhalers or the concurrent use of both steroid and LABA inhalers. Use of LABA inhalers has gone way up, but the rate of serious asthma attacks requiring hospitalization and the rate of asthma-related deaths have both gone down.

So why sell Serevent alone? GSK says it should stay on the market because doctors may wish to used a different dose of steroid than the one in the Advair combination product, or patients may need a different steroid than the one used in Advair.

But troubling questions remain for the joint FDA panel to resolve:

  • Why, if combination products are safer, does there still seem to be a significant increase in asthma-related problems with Symbicort?
  • Do LABA drugs do something to make asthma worse in some patients, or is it just that people who have LABA problems aren't getting their inflammation under control with corticosteroids?
  • Why do LABA-related adverse events seem to be more frequent in children under age 12?
  • If single-agent LABA drugs remain on the market, what is the best way to ensure patient safety?
  • Are there subgroups of patients for whom the risks of LABA drugs outweigh their benefits?

The joint panel's 27 voting members are scheduled to vote on Dec. 11, although the final questions they'll be deciding have not been announced.

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