FDA Experts Urge Ban on Cold Medicines for Young Children

SATURDAY, Sept. 29 (HealthDay News) -- U.S. health experts on Friday urged the federal Food and Drug Administration to consider banning the sale of over-the-counter cough and cold medicines for young children.

The recommendation, from FDA safety officials, would apply to decongestant use in children under 2, and antihistamines in those younger than 6, according to agency documents released Friday, theAssociated Pressreported.

The products include approximately 800 popular medicines that are sold in the United States under names like Toddler's Dimetapp, Triaminic Infant and Little Colds,The New York Timesreported.

A group of outside experts advising the FDA will consider the recommendation during a meeting on Oct. 18 and 19, and will then offer an opinion to the full agency.

In the safety review released Friday, the FDA experts recommended that all infant cough and cold products be removed from the market. They also recommended that the sizes of the droppers, cups and syringes packaged with products be standardized to reduce the possibility of confusion and overdose, theTimessaid.

An FDA review of records filed with the agency between 1969 and September 2006 found 54 reports of deaths in children associated with decongestant medicines made with pseudoephedrine, phenylephrine or ephedrine. It also found 69 reports of deaths associated with antihistamine medicines containing diphenhydramine, brompheniramine or chlorpheniramine, theAPsaid.

Most of the deaths were children younger than 2.

The Consumer Healthcare Products Association, which represents makers of over-the-counter medicines, backs the recommendation that the cold and cough treatments not be used in children younger than 2. As for antihistamines, the group recommends adding a warning that the drugs not be used to sedate young children, theAPsaid.

Also Friday, FDA officials announced a crackdown on drug companies that make unapproved prescription drugs containing the narcotic hydrocodone, which is used as a cough suppressant and pain killer.

Hydrocodone is one of the strongest drugs used to treat pain or to suppress cough. It's also widely abused and, if improperly used, can lead to illness and death. Overdoses of hydrocodone can cause breathing problems or cardiac arrest and can impair motor skills and judgment, U.S. Food and Drug Administration officials said.

"The FDA is announcing an action to stop the illegal marketing of any unapproved drug product containing hydrocodone," Deborah M. Autor, director of the agency's Office of Compliance, Center for Drug Evaluation and Research, said during a Friday teleconference.

Some pain-relief products containing hydrocodone, such as Vicodin, are FDA-approved. But most of the drugs with hydrocodone now marketed to suppress coughs have not been approved, officials said.