Agency medical staffers aren’t so sure and they’re recommending a more in-depth safety review of Serevent and Advair, according to documents posted on the FDA website in advance of a pediatric advisory committee meeting this coming week. These are Glaxo’s biggest-selling meds, by the way.

Although FDA staffers didn’t identify side effects unique to kids, they did find five deaths among nine adverse-event reports in children during a 13-month review Serevent. Three of the nine cases were associated with overdoses. Both meds, which contain the active ingredient salmeterol, already carry a Black Box warning about a risk of asthma-related death.

“There is no available pediatric data to indicate that the increased risk of asthma death and life-threatening exacerbations observed in adults does not also apply to children,” the FDA reviewers wrote in the briefing documents. “We conclude that salmetrol (Serevent) may have an unfavorable risk-benefit ratio in the treatment of pediatric asthma. We recommend a more thoroughgoing, formal risk-benefit analysis in the treatment of pediatric asthma.”

Advair, by the way, is a combination of the salmeterol and a steroid. Last year, the combined revenue for the two meds hit $6 billion. Glaxo believes the meds are appropriately labeled to reflect the safety profile of the products. The company also told The Wall Street Journal that “salmeterol continues to exhibit a favorable safety profile in pediatric subjects and the safety profile is similar to that seen in adults.”