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FDA Panel Set to Issue Opinions On Safety of 16 Drugs in Children
WASHINGTON – A food and Drug Administration panel is set to meet today to discuss the safety review of 16 drugs, including flu drug Tamiflu in pediatric patients.
The pediatric advisory committee will evaluate new and updated reports by the FDA staff that includes information on the drugs’ safety compiled over a year. The panel will then make recommendations that could include label changes or further investigation of adverse events.
The FDA isn’t required to follow the panel’s suggestions, but it usually does.
Although the panel today is to issue a opinion on Tamiflu’s label, on Tuesday the drug’s manufacturer, Roche Holding AG, said it would follow the FDA staff’s recommendation in the report and update the label to warn patients of potential abnormal behavior during treatment, including delirium and hallucinations.
In its report, the staff said the label should be changed following a review that found 103 cases of “neuropsychiatric adverse events,” including the death of a fourteen-year-old boy who fell after climbing on his condominium balcony’s railing. According to the documents posted on the FDA Web site ahead of today’s meeting, eight drugs under review didn’t raise any safety concerns. They include cholesterol-lowering medications Lipitor from Pfizer Inc. and Zocor from Merck & Co., Eli Lilly & Co.’s cancer drug Gemzar, and Johnson & Johnson’s Ditropan to treat bladder instability.
The other eight drugs either presented new unlabeled safety concerns or “other attributes,” including labeled but “serious adverse events of interest” and past safety concerns, the FDA said.
Included in this group are Pfizer’s Zyvox, GlaxoSmithKline PLC’s Zofran and Avandia, Forest Laboratories Inc.’s Celexa, Novartis AG’s Trileptal, Wyeth’s Rapamune and Abbott Laboratories’ Norvir.
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