FDA Mulls Limits on Kids' Cough Medicine

Some Experts Want to End Sales of Over-the-Counter Cough and Cold Medicine for Children

From the WebMD Archives

Oct. 2, 2008 -- Consumer groups and medical experts called on the FDA Thursday to pull children's cough and cold medications off the market or make them available only by prescription.

The pleas come as regulators mull a possible crackdown on over-the-counter cough and cold medicines for children, sold by the millions in pharmacies and grocery stores.

Last summer, the FDA warned consumers not to give cold medicines to children under age 2 because of serious and possible life-threatening side effects. Now officials are considering limiting sales of products intended for children up to age 6.

The FDA estimates that as many as 800 cough and cold medications are on the U.S. market. Companies sell an estimated 95 million packages of pediatric cough and cold medications each year, according to Information Resources, a market research firm.

"A lot of people don't know that the FDA has never required companies to show their products are effective," said Paul Brown, government relations manager at the National Research Center for Women and Families.

The agency's options range from stricter labeling and packaging requirements to banning companies from marketing products targeted for young children at all.

Joshua Sharfstein, MD, the Baltimore City Commissioner of Health, urged FDA officials to take off the market cough and cold medicines for children under 6. He also said the regulators should recall millions of those packages currently on store shelves. "Parents should know that there is less evidence than ever to support the use of over-the-counter cough and cold medicines for young children," he said.

The agency is also considering moving children's cold medicines from over-the-counter status to prescription-only sales.

"The cost to the health system would be enormous," Linda Suydam, president of the Consumer Healthcare Products Association, told WebMD. The group is the main trade organization for companies making cold remedies.

Lack of Data on Cold Remedies for Kids

Most available cold remedies use combinations of different active ingredients, and most have not been well-tested in young children, critics said Thursday.

At the same time, about 7,000 children under 11 go to emergency rooms each year after taking cough and cold medicines, according to the CDC. Roughly two-thirds of those occurred after children drank medication while unsupervised, the agency said.


But several experts told the FDA Thursday that cold medicines have shown little benefit for children's cold symptoms, which usually clear up on their own without medicine.

"The available data show cough and cold products to be ineffective for children with cough and cold symptoms. In the absence of evidence of efficacy, any risk associated with these drug therapies is unacceptable," said David Bromberg, MD, a pediatrician from Frederick, Md., who testified on behalf of the American Academy of Pediatrics.

Suydam told FDA officials and experts that the industry was planning dose studies of cough and cold medicines in children. She also said companies were planning public campaigns to educate parents on how to safely use the products in children.

It is likely to take years for the FDA to go through the process of changing the rules for children's cold medicines, officials said.

John K. Jenkins, MD, who directs the FDA's Office of New Drugs, said the agency is concerned that an outright ban on sales for children would drive parents to use more adult medications for their kids.

"We're very concerned that we'd see a shift in people using adult products," Jenkins told reporters. "Then you would have an even worse situation."

WebMD Health News Reviewed by Louise Chang, MD on October 02, 2008



Paul Brown, government relations manager, National Research Center for Women and Families.

Joshua Sharfstein, MD, Baltimore city commissioner, Department of Health.

Linda Suydam, Consumer Healthcare Products Association.

FDA Public Health Advisory: "Nonprescription Cough and Cold Medicine Use in Children," Aug. 15, 2007.

Schaefer, M.K. Pediatrics,Jan. 28, 2008.

David Bromberg, MD, American Academy of Pediatrics.

John K. Jenkins, MD, director, Office of New Drugs, FDA.

CDC web site.

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