The FDA is recommending an additional safety review of GlaxoSmithKline's Serevent and Advair and Novartis' Foradil in children.
An advisory panel of pediatricians is scheduled to discuss side effects of the asthma medications at a meeting on Nov. 27.
The FDA strengthened warning labels for the drugs nearly two years ago to limit use to patients who don't benefit from other medications.
“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 wrote in a report posted on its Web site.
The review didn't identify any adverse reactions unique to children but did imply that Serevent may have more risks than benefits for young users.
Global sales for Serevent and Advair rose 12% to $6.13 billion in 2006, making them the second best-selling medicines behind Pfizer's $12 billion-seller, the cholesterol drug Lipitor.