FDA reviewing kids' OTC cough meds

March 19, 2007

A petition filed by a group of pediatricians asked the FDA to bar drug manufacturers from marketing common cough/cold medicines to children under six.

A petition filed by a group of pediatricians asked the FDA to bar drug manufacturers from marketing common cough/cold medicines to children under six. It noted that while children's cold medicines were generally safe in recommended doses, many children were given more than one medicine. The petition also questioned the drugs' effectiveness in children. The agency then announced that a review of the safety of these products has been under way since the middle of last year. During a press conference, Charles J. Ganley, M.D., FDA director of the Office of Nonprescription Products, told reporters that the FDA is also looking at how the efficacy of these products was determined and how the data from adults were extrapolated to children. Meanwhile, Linda Suydam, president of the Consumer Healthcare Products Association, responded, "OTC cough and cold remedies have a long history of safety when used according to the label...The labels of all cough and cold medicines for children direct parents and caregivers to contact a physician before giving to a child under two."

 

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