Warning widens on cold meds for kids

WASHINGTON — Over-the-counter cough and cold medications should not be used in children younger than age 6, federal advisers concluded Friday after reviewing the products' safety and effectiveness.

The Food and Drug Administration (FDA) panel voted 13-9 to recommend against use of the products for children in that age group after concluding overwhelmingly there was insufficient evidence that the long-used remedies worked in youngsters.

"The sentiment here is that they should not be used," said Mary Tinetti, of Yale University School of Medicine, who chaired the group.

The panel, however, voted 15-7 to not make the same recommendation for children ages 6 to 11. But the advisers agreed there was no evidence the products do any good for that group, either.

The votes reflected a division within the committee. While there was clear consensus that the products' effectiveness had not been demonstrated and there was serious concern about their safety for the youngest children, particularly those younger than 2, several members said many parents and pediatricians nevertheless depend on the remedies.

"Parents are using these medications to relieve what they consider symptoms, which in reality means their child is sedated and they are able to sleep," said committee member Amy Celento-Stamateris, who represented parents. "My concern is that by taking these products off the market, parents would have limited alternatives."

The vote against use by children younger than 6 and an earlier vote that the products should be banned for those younger than 2 are likely to have a significant impact on dozens of products that have been mainstays for millions of parents.

Americans spend more than $300 million a year on such products, marketed under well-known brands such as Robitussin, Dimetapp and Tylenol.

The recommendation applies to medicines containing one or more of the following ingredients: decongestants, expectorants, antihistamines and antitussives.

The committee's recommendations also apply to antihistamines used to treat allergies, although the focus of the review was on their use in cough and cold medications.

The FDA is not bound by the committee's conclusions, but the agency usually follows the advice of its advisory panels. FDA officials said they would review the complex recommendations and decide how to proceed.

Because the products have been on the market so long, formal action could take years, officials said.

No one knows how many children have had adverse reactions to the medications, but the federal Centers for Disease Control and Prevention reported earlier this year that at least 1,500 children younger than 2 had complications in 2004 and 2005.

An FDA review prepared for the meeting described dozens of cases of convulsions, heart problems, trouble breathing, neurological complications and other reactions, including at least 123 deaths.

The hearing came a week after major manufacturers of the medications voluntarily withdrew 14 products designed for children younger than 2, including well-known brands such as Dimetapp Decongestant Plus Cough Infant Drops, Tylenol Concentrated Infants' Drops Plus Cold and Robitussin Infant Cough DM Drops.

The FDA convened the hearing to evaluate doubts about the products' effectiveness and the mounting evidence that the medications can cause serious complications.

The companies' representatives maintain that the products are safe and effective when used properly but said they withdrew products for infants and toddlers because of the risk of complications when misused.

Most complications occurred in children younger than 2.

The companies support adding warnings to the labels of the dozens of products still on the market to caution parents that they should not be used for children younger than 2 or to sedate children, and promised to launch a nationwide campaign about how to use the products safely. They also said they would conduct additional studies.

"We're going to be working with the FDA, and we believe these products will stay on the market," said Linda Suydam, president of the Consumer Healthcare Products Association, which represents drugmakers.

The hearing was prompted by a petition filed by a group of health officials led by Joshua Sharfstein, Baltimore's health commissioner, after the deaths of four children in that area.

"FDA and the companies should work quickly to end marketing of cough and cold products for children under age 6," Sharfstein said.

Many of the disputed products were approved decades ago when testing requirements were less stringent.

Although many leading medical groups have long recommended against their use, the products remain popular.

The panel concluded it was inappropriate to rely on studies conducted on adults to determine the effectiveness of the products for children and called for new research to test the products in children.

"Children are not just small adults," said Jesse Joad of the University of California, Davis, Medical Center.

Some of the drugs — including Wyeth's Dimetapp and Robitussin, Johnson & Johnson's PediaCare and Novartis' Triaminic products — have never been tested in children, something flagged as long ago as 1972 by a previous FDA panel.

An FDA review found just 11 studies of children published in the past 50 years. Those studies did not establish that the medicines worked in those cases, according to the agency.

Material from The Associated Press is included in this report.