FDA to Discuss Pediatric OTC Drugs, Warns Against Codeine Use

Rockville, MD (Aug. 16)-The US Food and Drug Administration announced it will hold a public meeting to discuss the safety and efficacy of over-the-counter (OTC) pharmaceutical products developed for the treatment of cough and cold symptoms in children. The Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee will meet Oct. 18 and 19 at The National Labor College (Silver Spring, MD) to provide advice and recommendations to the agency on FDA’s regulatory issues, according to the announcement in Federal Register 72 (158), 46091–46092 (August 16, 2007).

The meeting is in part a response to a citizen petition submitted to FDA on Mar. 1, 2007, requesting that FDA amend the OTC drug monograph for Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products in 21 CFR Part 341. The amendment would require that labeling for OTC antitussive, expectorant, nasal decongestant, antihistamine, and combination cold and cough products state that these products have not been found to be safe or effective in children under 6 years of age for the treatment of cough and cold. Moreover, the label would state that these products should not be used for the treatment of cough and cold in children under 6 years of age.

The petition also calls for FDA notification to manufacturers of these products that the terms “baby” or “infant” or product packaging displaying images of children under the age of 6 are not supported by scientific evidence and enforcement action may be applicable.

FDA also announced its concern that nursing infants may be at increased risk of morphine overdose if their mothers are taking codeine and are ultra-rapid metabolizers of codeine. The agency has reviewed all available information on this subject since a medical journal reported the death of a 13-day-old breastfed infant who died from morphine overdose.

Codeine is an ingredient in drug products used to relieve pain or treat cough. Once in the body, some of the codeine metabolizes to morphine. Some people, because of their genetic makeup, metabolize codeine much faster and more completely than others. These people, called ultra-rapid metabolizers, are more likely to have higher-than-normal levels of morphine in their blood after taking codeine. Mothers who are ultra-rapid metabolizers may have higher-than-usual levels of morphine in breast milk.

According to a separate report, FDA is requiring manufacturers of prescription products containing codeine to include the information about the risk for nursing infants in their drug labeling. In addition, the Center for Drug Evaluation and Research’s Office of New Drugs Deputy Director Sandra Kweder states that manufacturers of OTC products containing codeine will put similar information on their labels (Drug Industry Daily, Aug. 20).