WASHINGTON The Food and Drug Administration Pediatric Advisory Committee has recommended that the agency strengthen the boxed warning for asthma drug Serevent to reflect the risks of the product in children.
Andrew Mosholder, a medical officer with the FDA’s Division of Drug Risk Evaluation, told the committee that agency drug safety staff became concerned with the use of the product in children when a review of adverse event data revealed five patient deaths in children younger than 16.
The committee requested the FDA move to a more prominent position in relation to the labeling of the drug and they also, recommended the drug only be used as a second-line treatment. A statement regarding the drug’s risk in black patients was also requested.
In addition, the committee wanted labeling to include information that characterized the risk of the product relative to other risks, such as driving a vehicle or playing sports, so doctors could consider the information when prescribing the medicine.
GlaxoSmithKline, the manufacturer of the drug, said there is no new safety information that changes the risk-benefit evaluation of Serevent or warrants another review at this time.