FDA Panel: No Cold Medicine for Young Children

Elaine Zablocki

October 19, 2007

October 19, 2007 — A panel of government advisors recommended Friday that popular over-the-counter cold and cough medicines not be used in children who are 2 to 5 years old.

The recommendation comes on the heels of two days of meetings in which an FDA advisory panel scrutinized the safety and effectiveness of cold medicines for children.

The committee concluded that cold medicines have no effective use in children. Reports of potentially dangerous side effects led drugmakers several weeks ago to stop marketing cold and cough medicines for use in children under 2.

"The sentiment is what the sentiment is here, and that is that they shouldn’t be used," said Mary Tinetti, MD, a professor of medicine at Yale University and chairwoman of the FDA’s Nonprescription Drugs Advisory Committee.

The panel voted 13-9 to recommend that cold medicines not be used in children over 2 years old but under 6 years old.

Committee member Sean P. Hennessey, PhD, of the University of Pennsylvania School of Medicine, said the over-the-counter cold medicines should not be used in children "given that there’s no evidence of efficacy of the drugs and there’s evidence of harm of the drugs."

A similar vote for children between 6 years old and less than 12 years old failed 7-15.

There are hundreds of over-the-counter cold medicines using different cough and pain relievers alone and in varying combinations.

The FDA is considering whether to ban the marketing of the drugs for use in children.

The panel also voted to urge the FDA to ban the use of phrases like "doctor-recommended" on cough medicine packaging.

"I think from this day forward it has no credibility," said Marsha D. Rappley, MD, chairwoman of the FDA's Pediatric Advisory Committee. "And if it is used, it is to mislead people."

At the same time, the panel said drugmakers should be allowed to continue marketing cold medicines using combinations of drugs, if they can show the drugs are safe and effective in children.

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