Published Online: Friday, February 1, 2008

The FDA recently made its first ruling on OTC cough and cold medicines for babies and toddlers—avoid these drugs for children under age 2 "because serious and potentially life-threatening side effects can occur."

The issue surrounding cold remedies and young children heated up last October when drug companies stopped selling versions of medicines specifically targeted to babies and toddlers. At the same time, the FDA's own scientific advisers voted that the medications are not effective in small children and should not be used in children under age 6. The public health advisory was issued because the agency is concerned that parents have not gotten the message despite all the media coverage.

Still on the table is whether the remedies are safe and effective for children under age 12. Last fall, the agency's advisers did not recommend that children aged 6 to 11 stop using the medications. The group did, however, call for additional research to determine what effects the remedies have in youngsters overall. Meanwhile, an internal FDA group has not reached a consensus regarding children aged 2 to 11 years.

This month is the deadline to send recommendations to agency leaders, according to Charles Ganley, MD, directo r of the Office of Nonprescription Products at the FDA's Center for Drug Evaluation and Research. The FDA said to expect a decision by spring.

Latest Issues