FDA committee urges stronger warnings on asthma drugs for children.

FDA's Pediatric Advisory Committee's Nov. 28 urged that stronger label warnings focused on children be added to the packaging for GlaxoSmithKline's Serevent and Advair, two widely used asthma drugs, "The Washington Post" reported.

After a 2005 panel investigation focused mainly on the drugs' use by adults, FDA added a strong black box warning on both medications that they "may increase the risk of asthma-related death."

FDA drug safety reviewers had questioned whether the asthma drugs are appropriate for use in pediatric patient, according to a report in "The Wall Street Journal."

While the FDA staff memo said the review was limited by the small number and incomplete nature of some potential side-effect reports, the staffers still "conclude that salmeterol may have an unfavorable risk-benefit ratio in the treatment of pediatric asthma." They wrote that there was evidence inhaled steroid therapy, sometimes taken to protect against possible danger linked to salmeterol, was "not protective" in young people taking a similar drug, Novartis's Foradil. The reviewers suggested a more in-depth safety review of salmeterol that would also include Foradil.

FDA staffers found five deaths among nine adverse event reports in children during its 13-month review period of Serevent. Three of the nine cases were associated with overdoses of Serevent, the FDA documents said.

Glaxo said it believed Serevent and Advair were appropriately labeled to reflect the safety profile of the products. The drugs already carry a strong black box label warning about a risk of asthma-related death, which the drug company believes is sufficient.

The company also said "salmeterol continues to exhibit a favorable safety profile in pediatric subjects and the safety profile is similar to that seen in adults."