FDA Panel to Review Safety of Children's Cold Medicines

Joe Saunders

Attorney
(866) 735-1102 Ext 340

0 CommentsPrint ArticleSubscribe

The FDA will convene a panel to review the safety and efficacy of over the counter children's cold medicines. A group of doctors are pushing the FDA to put a warning on these over the counter products that they have not been proven safe and effective for children under six years of age. The petition was filed with the FDA earlier this year after a Centers for Disease Control and Prevention study of emergency-room records showed more than 1,500 reports of health problems and three deaths in children under age two were linked to cold and cough products in 2004 and 2005.

Most of the active ingredients in various medicines such as cough suppressants and nasal decongestants have been on the market for decades and were never required to undergo testing in children. Current dosing recommendations for children are extrapolated from adult doses.

For more information on this subject matter, please refer to the section on Drugs, Medical Devices, and Implants.