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Experts Say Drugs Are Ineffective, Potentially Risky for Children
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Reviewed By Louise Chang, MD
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.
FDA Action Uncertain
FDA officials say they're unsure how long the agency would take to issue public recommendations based on this week's meetings.
A decision to restrict or ban the use of cough and cold medicines in children could take years, says John Jenkins, MD, director of the FDA's Office of New Drugs.
"Our advice remains in general be cautious and aware of over-the-counter medications. When you are using them, follow the directions carefully," Jenkins says.
Jenkins also says parents should take care not to use more than one product containing the same ingredient. Such combinations have been blamed for some drug overdoses in children.
Despite experts' conclusions that cough and cold medicines have never been proven effective in pediatric patients, industry representatives maintain that studies showing some evidence of effectiveness are out there.
"These products are safe and effective, and parents have depended on them for decades," says Linda Suydam, president of the Consumer Health Care Products Association, the trade group representing over-the-counter drugmakers.
"We believe these products will remain on the market," she says
Suydam's group estimates that 95 million packages of cough and cold medicine are sold in the U.S. each year for a total of $311 million.
SOURCES: Mary Tinetti, MD, professor of medicine, Yale University; chairwoman, Nonprescription Drugs Advisory Committee, FDA. Sean P. Hennessey, PhD, assistant professor of epidemiology, University of Pennsylvania School of Medicine. Marsha D. Rappley, MD, chairwoman, Pediatric Advisory Committee, FDA. John Jenkins, MD, director, FDA Office of New Drugs. Linda Suydam, president, Consumer Health Care Products Association.
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