A voluntary market recall of medicines labeled for use in infants was recently announced by The Consumer Healthcare Products Association, a trade group representing Wyeth, Novartis, and Johnson & Johnson, the manufacturers of popular over the counter cold and cough medications Dimetapp, Robitussin, Pediacare, and Triaminic. This preceeded an FDA panel’s recommendation that over-the-counter medicines should not be used with children under the age of 6 due to ineffectiveness. The medications have never been tested in children, though the components themselves have been deemed safe, but no dosing standards were approved for children by the FDA. As of now the recall involves only medications for children under the age of 2, though The American College of Chest Physicians decided in 2005 that most active ingredients are no more effective than placebo and recommend not using the medications in children under the age of 14.
Specific Ingredients To Avoid in Children's Cold Medication
Steps are being taken to address concerns about safety. Hydrocodone is a narcotic used in some cough remedies that has not been approved for the treatment of cold and cough in children. The FDA stated on Oct. 1 that they will take legal action against any companies marketing such medications for use in children. In June of 2006 the FDA took enforcement action to stop the manufacture of carbinoxamine-containing medications that had not been approved by the agency. Many of the medications were inappropriately labeled for use in infants and young children. Though manufacturers were required to cease production, some products might still be in distribution. Even earlier, in 1997, the American Academy of Pediatrics issued a policy statement advising education for parents regarding the ineffectiveness and risk of using medications containing codeine and dextromethorphan in young children.
