WASHINGTON The Food and Drug Administration will be conducting a meeting of its pediatric advisory committee to discuss the safety of a number of drugs, including the influenza medications Tamiflu and Relenza and the asthma drugs Serevent and Advair, according to online reports.
The asthma medications already carry a black-box warning about a risk of asthma-related deaths, but none of the side effects has been specified to children. 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, the active ingredient in Advair and Serevent, may have an unfavorable risk-benefit ratio in the treatment of pediatric asthma."
FDA safety reviewers also suggested that both Tamiflu and Relenza should get label updates with information about neuropsychiatric events, such as hallucinations, reported occasionally among users; Tamiflu already has a label precaution about this potential side effect.
Roche, which manufactures Tamiflu, and GlaxoSmithKline, which makes Relenza as well as Advair and Serevent, both agree that the labeling on the drugs is fine the way it is, but are “open” to considering suggestions made by the FDA.