October 2008

FDA experts want to ban OTC cold drugs for kids under six

Last year, citing concerns over safety and effectiveness, several experts from the US Food and Drug Administration recommended that the agency ban all over-the-counter, multi-symptom cough and cold medicines for children under six. Although their advice managed to stay under the public radar, a few more progressive medical experts have praised the advice.

Ken Haller, MD, associate professor of pediatrics at Saint Louis University, said recently that the regulatory action is long overdue.

"Cough and cold medicines were first approved many years ago under the assumption that children's bodies worked like adult ones, but on a smaller scale," Dr. Haller explained to parents. "They were never tested for safety and effectiveness in children. There are a lot of side effects associated with these medicines."

While infant cough and cold medications were pulled off shelves last year, nearly 800 over-the-counter cough and cold medications are still available for children over two years-old -- a decision with which Haller disagrees.

"I feel strongly that they should all be taken off the market," he stated.

"Numerous studies have shown that these do not make children with colds and sore throats feel better any quicker than doing nothing. And over the years, thousands of children have been hospitalized and scores of children have died as a result of taking these drugs because of their side effects and the fact that many of these drugs contain multiple active ingredients, which add up to a harmful dose."

In the first two years of life, it's normal for children to get an average of six significant upper respiratory infections per year. "Parents often feel powerless when their kids are sick and are desperate to help them feel better," Haller said. "But drugs are not the answer for every illness. Not only will these over-the-counter medicines not help your child feel better, but they can be very dangerous, too."

SOURCE: Saint Louis University Medical Center, Sept. 8, 2008.