Serevent Side Effects Lawsuit News

FDA advisers eye enhancing Glaxo asthma drug label

WASHINGTON, Nov 28 (Reuters) - U.S. regulatory advisers on Wednesday are mulling whether to beef up warnings on GlaxoSmithKline's (GSK.L: Quote, Profile , Research) asthma drug Serevent following reports of several deaths in patients taking the drug.

The U.S. Food and Drug Administration expert panel on drugs for children is discussing nine new cases of adverse events in kids taking the drug, including five deaths. Two of those deaths were attributed to patients' underlying asthma, according to FDA documents.

The panel will make a recommendation to the FDA later on Wednesday on whether to beef up the label. The FDA typically takes the advice of these advisory panels.

Serevent already contains a warning that long-acting beta agonists can sometimes trigger severe asthma attacks and death.

Serevent, a long-acting beta agonist used to ease breathing, is also included in Advair, Glaxo's biggest product with global sales of about $6.8 billion.

FDA staffers last week reported the new cases from its adverse event database, through 2007, noting that the drug, generically called salmeterol, "may have an unfavorable risk-benefit ratio" in treating asthma in kids.

Glaxo stands by the safety of the drug and has provided additional clinical information to the FDA. (Reporting by Kim Dixon; editing by Mark Porter)

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