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FDA: Asthma Drugs Serevent, Symbicort and Foradil Subject of Hearing

The FDA has informed that three popular asthma medicines may increase risks of hospitalization and death in some asthma patients.

The safety of the drugs - Serevent, manufactured by GlaxoSmithKline P.L.C.; Symbicort, made by AstraZeneca P.L.C.; and Foradil, from Novartis AG - will be reviewed by outside medical advisers to the FDA at a two-day hearing next week in Rockville, Md.

A fourth drug, Advair made by GlaxoSmithKline, had no increased risk of respiratory complications, FDA staff said. Advair has about $4 billion in annual sales and is Glaxo's biggest product.

Medical experts will consider the potential risks of all LABAs, including Advair, at the two-day hearing Wednesday and Thursday, will hear presentations by the drugmakers, and will make recommendations. The drugs already carry strong warnings, but the findings next week could lead to more specific instructions for patients.

Souurce here.

Full post as published by A Georgia Lawyer on December 08, 2008 (boomark / email).