The Food and Drug Administration said Wednesday that it is stepping up a review of whether over-the-counter cough and cold medicines are safe for children under 6.
Two FDA advisory committees will examine the risks and benefits of these products at a meeting in the fall. The agency also issued a statement urging parents to follow the prescribing information for young children to avoid harmful reactions or potentially deadly overdoses.
The agency says it began investigating nonprescription cold medicines marketed for children last year. Pediatricians led by Baltimore Health Commissioner Joshua Sharfstein voiced similar concerns in a March 1 petition to the FDA.
Americans spend more than $284 million a year on pediatric cold remedies such as Dimetapp, made by Wyeth, and Children's NyQuil, made by Procter & Gamble Co., according to market-research firm AC Nielsen.
"Questions have been raised about the safety of these products and whether the benefits justify any potential risks from the use of these products in children, especially in children under 2 years of age," the FDA said in a statement posted on its Web site.
In 2004 and 2005, an estimated 1,519 children under age 2 were treated in emergency rooms in the United States because of harmful reactions to cough and cold medications, according to a report released in January by the Centers for Disease Control and Prevention. Three children died.
Sharfstein and his colleagues from other cities urged regulators to recommend that parents and doctors don't give over-the-counter nasal decongestants, antihistamines and expectorants to children under 6 because there's no proof that they work. The FDA should also threaten penalties if manufacturers keep advertising these products for children, the doctors said in their petition.
At their meetings on Oct. 18 and 19, the FDA's pediatric and nonprescription drugs advisory committees will consider these suggestions and the effects that they would have on the use of the products in children and the recommendations of doctors, the agency said.