PharmTech Followup: Pediatric Cough and Cold Medicines

Rockville, MD (Oct. 16)-During the past several months, Pharmaceutical Technology has been covering the US Food and Drug Administration’s rulemaking on over-the-counter (OTC) cough and cold medications for children. In January 2008, the agency issued a Public Health Advisory recommending that these drugs not be used to treat infants and children under the age of 2 because serious and potentially life-threatening side effects can occur. Wyeth (Madison, NJ), Prestige Brands (Irvington, NY), Johnson & Johnson (New Brunswick, NJ), and Novartis (Basel) voluntarily withdrew related medications for children under age 2 in October 2007. (See "Public Comment on Cough and Cold Meds for Kids.")

On Oct. 2, 2008, FDA held a public meeting to discuss cough and cold medications for pediatric use before it finalizes a proposed rule to revise the pediatric labeling contained in the "Final Monograph for Cough, Cold, Allergy, Bronchodilator, and Anti-asthmatic Drug Products for Over-the-Counter Human Use."

Last week, the president of the Consumer HealthCare Products Association (CPHA), Linda Suydam, issued a statement saying that “children’s over-the-counter (OTC) cough and cold medicines are safe and effective when used as directed” and that “research shows that dosing errors and accidental ingestions-not the safety of the ingredients themselves when properly dosed-are the leading causes of rare adverse events in young children.”

The statement went on to report that the “leading manufacturers of these medicines are voluntarily transitioning the labeling on oral OTC pediatric cough and cold medicines to state ‘do not use’ in children under four years of age.” For products containing certain antihistamines, manufacturers are voluntarily adding new language that warns parents not to use antihistamine products to sedate or make a child sleepy, said Suydam. The changes will take place throughout the 2008–2009 cough and cold season. Additional dosing device changes and packaging may be coming as well to help reduce dosing errors with these medications, according to the CPHA statement.

FDA responded to CPHA's statement on Oct. 8, 2008, with its own statement on OTC pediatric cough and cold medications. "Although this new labeling is inconsistent with the current monograph, FDA will not object, under the circumstances presented here, to the new label modification stating 'do not use in children under 4,' which reflects a more restrictive use of the drugs in children. The steps that are being taken by CHPA will not affect the availability of the medicines, but this voluntary action will result in a transition period where the instructions for use of some OTC cough and cold medicines in children will be different from others."

The agency says it will continue to work with the Centers for Disease Control and Prevention to monitor the ongoing use of cough and cold medications for children and to develop educational materials for parents and consumers. FDA also plans to continue to reach out to the scientific community to obtain up-to-date information and scientific data about the effects of these products in children, with future regulatory steps in mind.