Doctors: Limit kids’ cold remedies

Pediatricians urged U.S. regulators to restrict over-the-counter cold medicines for children, saying the remedies used for decades don’t work and may be dangerous.

Members of the American Academy of Pediatricians asked a panel of Food and Drug Administration advisors Thursday to recommend that the agency ban marketing cold medicines for children younger than 6. Products such as Wyeth’s Dimetapp and Novartis AG’s Triaminic haven’t been shown to work on this age group and may be hazardous, doctors said.

Action by the FDA would follow a decision by drug makers last week to withdraw 14 cold medicines designed for infants in response to concern from doctors, regulators and lawmakers. The FDA said it had received 54 reports of children’s deaths linked to decongestants and 69 associated with antihistamines from 1969 to 2006, involving both prescription and over-the-counter drugs. Many involved overdoses in children younger than 2.

“If so many experts are advising against these medicines for children, then why are they so widely used?” Baltimore Health Commissioner Joshua Sharfstein asked.

The FDA’s advisory panels on nonprescription and pediatric drugs will resume their meeting today to hear from doctors, drug makers and FDA staff on the safety and effectiveness of cold and cough medicines for children. The advisors will vote on recommendations that may include restricting marketing, adding label warnings or requiring studies in children.

The FDA usually follows its panels’ recommendations, although it isn’t required to do so.

The Consumer Healthcare Products Assn., a Washington-based trade group that represents nonprescription drug makers, said the risks might be mitigated by educating parents better and adding a warning label to all pediatric cold drugs.