US FDA to restrict OTC cold and cough drugs

The US Food and Drug Administration's Nonprescription Drugs and Pediatric advisory committees, in a joint meeting, have voted to restrict or ban the sale of over-the-counter cough and cold medicines for children up to 11 years old. An outright ban for under two-year-olds was supported by 21 votes to one, with smaller majorities also supporting moves to ban the products for children aged two to six and six to 11 years old. The votes are non-binding on the FDA.

FDA c'ttee considered 123 reported deaths

The Baltimore Sun reported that the joint session of the advisory committees had recommended changing the labeling for the products from "consult a physician" to "do not use" for children aged less than six years. The Washington Post also noted that the Centers for Disease Control and Prevention (CDC) had reported this year that, during 2004 and 2005, "at least 1,500 children younger than two suffered complications." The FDA also has records of adverse events affecting children, including convulsions, heart problems, breathing difficulties, neurological complications and at least 123 deaths.