FDA Says Serevent Risk-Benefit Profile for Use in Kids Is Unfavorable

The FDA is recommending to the Pediatric Advisory Committee that a thorough risk-benefit analysis for GlaxoSmithKline’s (GSK) asthma treatment Serevent is warranted as the product may have an unfavorable risk-benefit profile for use in children. The committee will meet Nov. 28 to discuss the product.

Serevent (salmeterol xinafoate), a long-acting beta agonist (LABA), has two pediatric asthma indications: the prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease and the prevention of exercise-induced bronchospasm in patients 4 years of age and older.

Data from clinical trials conducted in adults showed an increased mortality risk for patients on the drug. There is no reason to discount those findings when considering their application to children, the FDA said.

“Recommendation for a study in children may be warranted but may not be feasible because of the difficulties in enrolling a sufficient number of patients to assess infrequent but severe asthma events, thus making results unavailable for many years,” the FDA said.

Further, the agency said it has not been shown that concomitant use of inhaled corticosteroids (ICSs) protects against severe asthma outcomes associated with LABA therapy. In fact, there is evidence that ICSs are not protective in children taking Novartis’ LABA Foradil (formoterol fumarate) and that data are relevant to a new risk-benefit analysis of Serevent, the FDA said.

The increased mortality risk associated with Serevent led the FDA to issue a public health advisory requesting physician labeling for LABAs be updated with warnings for asthma-related death. GSK previously criticized the FDA for issuing the advisory.