FDA to revise criteria for child cold medications

August 26, 2008

The US Food and Drug Administration (FDA) announced it would revise criteria for over-the-counter cough and cold medications for children, according to The Washington Post.

The US Food and Drug Administration (FDA) announced it would revise criteria for over-the-counter cough and cold medications for children, according to The Washington Post.

The FDA will hold a hearing on October 2 to investigate the issue further, such as what studies need to be conducted to evaluate the medications, whether the treatments should be available without a prescription, and how doses should be determined.

In October, a joint meeting of the FDA's Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee was held to review safety and efficacy concerns of child OTC cough and cold products. The committees recommended against the use of these products in children under the age of 6, due to a lack of proven effectiveness and the need for pediatric clinical trials.