FDA Panel : No evidence cold medicine works in Kids

WASHINGTON - A U.S. Food and Drug Administration panel said Friday, October 19th there is no evidence that popular over-the-counter cold and cough medicines work in children, and said the products shouldn't be used in children younger than age 6.

"There's overwhelming evidence they are not generally recognized as effective in (children) age 2 to 12," said panel member Thomas Newman, a professor in the epidemiology and biostatistics department at the University of California, San Francisco. While panel members said there was "modest" evidence that the drugs work in adults, they said the handful of studies conducted in children suggest the drugs don't work. The panel unanimously called for new studies in children.

The panel voted 13-9 to recommend that over-the-counter cold and cough products not be used in children younger than age six. An estimated 95 million units of over-the-counter cold and cough medicines are sold each year in the U.S. for adults and children.

While the panel overwhelmingly said the products haven't been proven to work in children 11 and younger, the panel, by a vote of 15 to 7, stopped short of recommending the products not be used at all in older children.

Amy Celento-Stamateris, the patient representative on the panel, said if there were no children's cold and cough products on the market, "there are many people who will administer (adult) products to their children because they work for them and I'd be very concerned."

In advance of the meeting, major drug companies said last week they would stop selling cold and cough products aimed at children younger than 2 years old. Some of the products include an infant version of Johnson & Johnson's (JNJ) Tylenol Plus Cold, Novartis AG's (NVS) Triaminic Infant & Toddler Thin Strips Decongestant and a Robitussin product sold by Wyeth (WYE).

Linda Suydam, president of the Consumer Healthcare Products Association, a trade group that represents makers of over-the-counter drugs, said products for children 2 to 6 years old will remain on the market.

"These products are safe and effective and parents rely on them," she said, adding that industry would conduct additional studies to show the drugs are effective in children.

A group of Maryland doctors petitioned the agency earlier this year to require the products to state that they aren't safe and effective for use in children younger than age 6, which prompted the review of children's cold and cough medicines by the FDA. The FDA said it wanted the panel's advice on whether the products were safe and effective in children 11 and younger before deciding on the petition.

FDA officials said they needed time to review the panel recommendations before deciding what to do next and said any labeling changes would have to go through a lengthy federal rule-making process. But in the meantime, John Jenkins, director of the FDA's Office of New Drugs, said the agency would "get back to the public in the near future about whether we have any recommendations about the safe and effective use of these products."

Last month, an analysis prepared for the meeting by an FDA medical reviewer said cold and cough medications in children younger than age six have been tied to "serious side effects, including death." However, the panel focused its discussions more broadly on whether the drugs worked and said safety problems seen with the drugs were small compared to overall use of the products.

Most of the active ingredients in various medicines, such as cough suppressants and nasal decongestants, have been on the market for decades and were never required to undergo testing in children. Current dosing recommendations on children's cold and cough medicines are extrapolated from adults. Generally, the dose in children ages 6 to 12 is about half the adult dose, while the dose in children ages 2 to 6 is one-quarter the adult dose. For children younger than 2, the product labels instruct parents to consult a doctor.

The FDA noted that only 11 studies of cold and cough products have been conducted on children during the last 50 years, and that most of them found the products weren't effective. However, the FDA also said many of the studies had design flaws.

The trade group's representative, Suydam, said the drugs are safe and effective when used at recommended doses and several studies have been conducted in adults showing the drugs work. She said drug makers agreed to pull products aimed at children age 2 and younger because of the potential for overdose when, for example, more than one product is used at the same time.


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Article written by Jennifer Colbert Dooren, Dow Jones NewsWires