The U.S. Food and Drug Administration staff posted documents containing concerns about rare and potentially fatal side effects of Advair and Serevent when used by children.
Used to treat asthma, GlaxoSmithKline stated that they are confident that the benefits of Advair and Serevent outweight any risks. Nine cases of adverse event in children under 16 were reported, including 5 deaths, since GSK was granted pediatric exclusivity in March 2006 according to papers posted on the FDA website.
Advair, GSK's biggest product with sales of $6.8M worldwide, contains servent, a long-acting beta agonist that is used to ease breathing. The company stated that it had provided clinical data that it believes proves the safety of both products.
"GSK has submitted a thorough safety review of salmeterol-containing products in pediatrics. The overall assessment of the data confirms the favorable safety and efficacy profile of Serevent and Advair when used according to the product labels," a spokeswoman said. "GSK believes the product labels reflect the available safety information for children four years of age and older."
In November 2005 the FDA issued a warning that drug containing long-acting beta agonists can sometimes trigger severe asthma attacks and even possibly death.
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