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Ban cold medicines for children under 6, doctors urge

WASHINGTON - Citing deaths, hallucinations, seizures and heart-rhythm disturbances, doctors called Thursday on a joint U.S. Food and Drug Administration panel to forbid the use of over-the-counter medications for children under age 6.

If panelists agree that the multisymptom drugs should be tightly restricted, and some members said they did, the decision could have an impact on the availability of nonprescription cough and cold products for older children.

Two influential FDA advisory committees - the pediatric and nonprescription drug panels - were scheduled to vote today on the drugs' fate. Some doctors have asked the agency to reconsider rules on the remedies, saying that conclusions about the effects of such products on children were largely extrapolated from studies involving adults.

Last week, several major drugmakers withdrew 14 pediatric cough and cold medications for children up to age 2. The petitioners are pushing to expand that to children under 6.

The medicines have been marketed for use in children for decades, with drug companies spending $50-million a year on ads and consumers spending an estimated $500-million a year on the drugs.

Still, it has long been acknowledged that little or no data from studies in the very young show that the medicines are safe and work. Worse, some studies suggest the medicines are no better than dummy pills.

"When a treatment is ineffective, its risks - if not zero - always will exceed its benefits," said Dr. Michael Shannon, a Harvard Medical School professor who was among the petitioners.

The drug industry says the widely used medicines are safe and work but can lead to death and injury from overdoses or misuse in infants.

Dr. Mary Tinetti, chairwoman of the FDA panel, said petitioners reported only 123 deaths over 27 years. "Millions and millions of parents are using these," she said.

Linda Suydam, president of the Consumer Healthcare Products Association, which represents makers of over-the-counter drugs, said, "The vast majority of consumers are using these medicines properly and serious adverse events are rare."

[Last modified October 19, 2007, 01:09:32]