Cold drug ban for children is advised

SILVER SPRING, Md. - A Food and Drug Administration panel of advisers voted yesterday 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 shown 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 was taken a week after major manufacturers agreed to withdraw more than a dozen cough and cold products labeled for use for 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 under 2, but its vote to ban them in children ages 2 to 5 was 13 to 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 had previously been "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 Dr. Charles J. Ganley, director of the FDA's office of nonprescription products.

The FDA has the power only to 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 the age of 6 and such 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 of their use 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. But most panel members said that if the drugs have not been shown to be effective in young children, they should not be available.

"Products for children under 2 were withdrawn from the market and the world didn't come to an end," said Dr. Sean P. Hennessy, a panel member from the University of Pennsylvania School of Medicine.

The panel also voted unanimously that no product should be allowed to market itself as "doctor recommended," a pitch many on the panel said was egregious because most pediatric groups do not recommend the drugs for use in young children.

The panel cited a growing number of studies that have found that popular cough and cold drugs work no better than placebos in ameliorating the effects of the common cold in children. And they said it was time to throw out the assumption that drugs that help adults will work just as well in children.

"Children are not just small adults," said Dr. Jesse Joad, a panel member and pediatrician from the University of California, Davis Medical Center.

Children's cough and cold medicines were approved in the early 1970s when regulators generally assumed that adult drugs were always helpful in children. Since then dozens of drugs first tested only in adults have been found to be entirely ineffective, and sometimes even dangerous, in children.

Whether drug makers will follow through on these recommendations to undertake large studies is far from clear. Nearly all of the medicines commonly used in over-the-counter remedies long ago lost patent protection, so any money that manufacturers spent on studying these drugs would also benefit competitors who spent nothing.

Manufacturers say their medicines are effective and safe when used as directed and they have promised to undertake an educational campaign to reduce medication errors.

The panel's vote is a reminder that many of the drugs Americans commonly use have never been examined closely and may not work. Standards for clinical trials have changed dramatically over the past 30 years, but thousands of drugs presently sold were approved under older, less stringent standards.

There are about 800 pediatric cough and cold products sold in the United States that use one or more of 39 different drugs. Parents spend about $500 million every year buying nearly 95 million boxes containing 3.8 billion doses.

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, Fla., told the committee that his son's pediatrician 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 condition. Dimetapp has since been reformulated.

"Please do the right thing and remove these drugs from the shelves immediately," he said.