FDA reconsiders Glaxo asthma meds

The FDA is taking a second look at the safety of three asthma drugs used in kids: GlaxoSmithKline's Serevent and Advair, and Novartis' Foradil.

Here's the story: Serevent and Advair contain the active ingredient salmetrol. This so-called beta agonist help prevent asthma attacks in most kids, but ironically enough, can cause severe attacks in a small number of children--attacks so severe, they can be fatal. Between 1994 and 2007, the agency received 23 reports of deaths possibly caused by Serevent; 14 of those reports involved an actual worsening of asthma symptoms. Between 1999 and 2007, FDA reports show, 15 Advair patients died.

Last year, the agency added a black-box warning of asthma-related death to the drugs' labeling. Now, FDA staff is recommending a formal review of the data on salmetrol. The agency also wants to include Foradil in that review; formoterol, its active ingredient, is also a beta agonist. An advisory committee is meeting Nov. 28 to discuss.

- see the meeting notice from the FDA
- read the adverse event report on Salmetrol
- check out the MarketWatch article

Related Articles:
GSK fights claim it manipulated asthma trial data. Report
Advair fails to hit goal in COPD trial. Report
GSK nixed on Advair application. Report

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