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FDA to Review Children's Cold and Cough Drugs

2007-03-07

The Food and Drug Administration will review over-the-counter cold and cough medications for children, with particular attention to use in children younger than 2 years, the New York Times reports.

Popular cold and cough remedies can cause cardiac problems when used at higher than recommended doses. Rarely, complications have been noted at standard doses. According to a recent CDC survey, some 1500 children were treated during 2004-2005 for adverse effects related to these drugs, including hypertension, arrhythmias, and stroke; three deaths in infants aged younger than 6 months were identified.

The Times reports that pediatricians and public health officials filed a petition yesterday asking the agency to stop manufacturers from marketing these products for children under age 6.

"We have no data on these agents of what's a safe and effective dose in children," the director of the FDA's office of nonprescription drugs told the newspaper.

New York Times

Drugs