FDA Warns Against Giving Cough Medicine to Toddlers

The Food and Drug Administration, concerned about the number of children being accidentally overdosed on over-the-counter cough and cold medicines, yesterday warned parents never to give children younger than age 2 such products without a doctor's approval.

The warning came as the agency announced plans to convene a panel of experts Oct. 18 to review the use of popular cold medicines in children because of mounting concerns about whether the remedies are being used safely.

The FDA began investigating the issue after public health authorities raised questions about the products, citing reports of hundreds of overdoses that resulted in a handful of deaths. Doctors petitioned the FDA in March to review the situation.

"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 2 years of age," the agency said in an advisory.

The FDA's decision was welcomed by those concerned about the medications.

"The fact that they are doing this is illustrative that this is a real problem that is on their radar screen," said Baltimore Health Commissioner Joshua M. Sharfstein, who was among those petitioning the agency.

Sharfstein noted that over-the-counter cold and cough medications have never been proven to be effective in children, and parents can easily inadvertently administer the medications in doses that can cause heart problems and other dangerous side effects.

"There's no good evidence of the efficacy of these products, and there are significant safety concerns about their misuse," he said.

Current labels already warn parents not to use the medications on children younger than age 2, indicating that stronger action is needed, such are possibly barring direct marketing of the products for use in young children, Sharfstein said.