GlaxoSmithKline's asthma drugs Serevent and Advair, the company's biggest-selling medications, may have rare and deadly side effects for children, safety officials at the U.S. Food and Drug Administration said.
Nine patients under age 16 were harmed, including five who died, while taking Serevent in the 13 months after it was approved in the U.S. for children in 2006, a safety review found. An advisory panel of pediatricians is slated to discuss side effects from Serevent and other medications on Nov. 27.
The FDA strengthened the warning labels for Serevent, Advair and Novartis AG's Foradil almost two years ago, limiting use to patients who don't benefit from other drugs. A study found patients using Serevent had a fourfold increase in asthma- related deaths, while others showed it and Foradil increased asthma exacerbations and hospitalizations in adults and children, according to the FDA staff memo Oct. 24, 2007.
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