Panel sounds alarm on Glaxo drug
U.S. regulatory advisors recommended strengthening safety warnings on GlaxoSmithKline’s asthma drug Serevent amid new reports of deaths among children taking the drug.
A Food and Drug Administration expert panel reviewed nine new adverse-event reports on children taking the inhaled treatment, including five deaths in about a year.
At least two panelists said the data were so convincing that Serevent should be pulled from the market. The FDA said it would consider the safety of all drugs in the class, called long-acting beta agonists, at a future meeting.
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