FDA Warns Against Young Children’s Use of Cold Meds

FDA on Wednesday issued a public health advisory that warns parents not to administer over-the-counter cold and cough medications to children younger than age two without consultation with a physician, the New York Times reports (Harris, New York Times, 8/15).

The advisory states, "Questions have been raised about the safety of these products and whether the benefits justify any potential risks from the use of these products in children, especially in children under two years of age" (Stein, Washington Post, 8/16).

The current labels for such medications include a similar advisory, but many parents do not adhere to the warning, FDA said.

FDA spokesperson Susan Cruzan said, "We continue to see adverse effects associated with the medicines because people are not using them properly." In the future, FDA might consider more serious regulatory actions, such as limits on the availability of such medications, she said (New York Times, 8/15).

In 2004 and 2005, at least 1,519 children younger than age two experienced serious health problems after they took such medications, and three of those children died, according to a CDC study released in January (Larkin, Bloomberg/Philadelphia Inquirer, 8/16).

Some of the "injuries and deaths associated with these products have resulted when parents gave two different products to their child, not realizing that both contained identical medicines, resulting in an overdose," the Times reports. In rare cases, children experienced health problems when they took recommended doses of such medications.

According to the Times, the debate over the safety of OTC cold and cough medications has resulted "because the standards for drug approvals have changed sharply in the decades since many of the medicines in children's cough and cold products were approved."

Pharmaceutical companies, which never have tested such medications in children, "simply assumed that they would work in children," but such "assumptions, once common, are no longer acceptable," the Times reports (New York Times, 8/15).

A group of physicians and public health officials in March petitioned FDA to review the safety and efficacy of such medications (O'Brien/Bor, Baltimore Sun, 8/16).

In response, two FDA advisory committees, the pediatric and nonprescription drugs committees, on Oct. 18 and 19 will meet to discuss potential regulatory actions against such medications. The petition asked FDA to recommend that physicians and parents not administer such medications to children younger than age six and penalize pharmaceutical companies that promote such treatments for use in children (Bloomberg/Philadelphia Inquirer, 8/16).

However, "dramatic regulatory action against the drugs" is "unlikely," and pharmaceutical companies "have little incentive" to test such medications in children because their patents on the treatments have expired, the Times reports (New York Times, 8/15).