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Divided FDA Panel Votes To Ban Children's Cold Drugs

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By GARDINER HARRIS, The New York Times

Published: October 20, 2007

SILVER SPRING, Md. - A Food and Drug Administration panel of advisers voted Friday to ban scores of popular over-the-counter cough and cold products intended for children under the age of 6 because they have not been proved to work and can cause injuries.

If put into practice, the vote could transform pharmacy shelves and change the way many parents cope with the myriad colds caught by young children every year. The vote comes a week after major manufacturers agreed to withdraw more than a dozen cough and cold products labeled for use in infants and babies.

But there are reasons to suspect that further changes, if they come, will not be immediate.

The panel voted unanimously to ban these products for use in children younger than 2, but its vote to ban them in children aged 2 to 5 was 13-9. The FDA usually follows the advice of its independent expert panels, but the closer the vote the more likely the agency is to ignore the advice.

Also, there are limits to the FDA's powers to regulate over-the-counter products that previously had been determined to be 'generally recognized as safe and effective,' as pediatric cough and cold products have.

'You may all vote that they should go away today but under administrative procedures that may not happen,' warned Charles J. Ganley, director of FDA's office of non-prescription products.

The FDA only has the power to immediately recall products that it determines represent an immediate hazard to public health.

Still, the committee's vote will force difficult choices for the makers of these products. If they continue to market products for children under age 6 and a child is injured, the committee's vote could open the maker to considerable liability.

Manufacturers contend that their products are safe and effective, that many of the problems associated with the medicines come from unintentional overdoses and that an educational campaign could solve most problems.

The panel voted overwhelmingly that there is no evidence that these medicines have any effect and that more studies must be done. Despite deciding this, however, nine panel members shied away from an outright ban in young children, arguing that doctors and parents needed to have something to give ill children.

Amy J. Celento-Stamateris, a patient representative on the panel from Nutley, N.J., said she was worried that if the panel voted to remove all pediatric products from the market, parents would end up giving to their children products intended for adults, raising fears of overdoses.

'My concern is that by taking these medications off the market, parents have limited alternatives,' Celento-Stamateris said. 'I'm not going to name names among my acquaintances, but people do use these medications to make their children get some sleep.'

Studies have not only failed to prove that the drugs are effective, but a growing number of reports show that they have dangers.

Daniel A. Mannello of Largo told the committee that the pediatrician for his son, Dennis, suggested that he be given Dimetapp as an infant, and the medicine caused scarring in the boy's brain that has led to chronic seizures. Dennis, now 9, is facing brain surgery to relieve the debilitating condition. Dimetapp has since been reformulated.

'Please do the right thing and remove these drugs from the shelves immediately,' Mannello said.

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