FDA Probing Safety of Advair and Serevent for Children

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There seem to be an alarming number of opportunities for GlaxoSmithKline pharmaceutical whistleblowers. Today the concern is all about potential fatal side effects of Advair and Serevent in children who take the drugs to treat asthma.

Five deaths, and four cases of "adverse events" were reported in children under 16 since March 2006, when GSK was granted pediatric exclusivity. Just five months earlier, in March of 2005, the FDA issued a warning that drugs containing long-acting beta agonists (such as Advair) can trigger severe asthma attacks and even possibly death.

GSK isn't worried. They said they've provided clinical data that "proves" the products are safe, and they're confident that the benefits outweigh the risk. Advair is a huge seller for GSK, with sales of $6.8M worldwide.