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Children’s Cough and Cold Products Recalled By Asal Sadatrafiei Early last week, several companies voluntarily pulled their cough and cold products off the market. This news came just as San Francisco Supervisor Michela Alioto-Pier was proposing a bill to place warnings next to these same products on the shelf. The proposed warnings would advise consumers not to use these products in children under two years of age. This warning would complement the explicit language found on the product advising against use in children under two years of age and to seek consultation with a health-care provider. Dr. William Soller, Executive Director of the UCSF Center for Consumer Self-Care and Health Sciences Professor of Clinical Pharmacy, explains that the packages depicted images of infants whereas the labels clearly state the products should not be used in children under two years of age. This “label gap” may have led to some of the adverse effects, including a few fatalities, which were reported to the Food and Drug Administration (FDA). The FDA held a Public Health Advisory Meeting late last week from October 17 to 18 to address issues raised by a Citizen Petition. The petition was authored by 16 health professionals and submitted to the FDA in March 2007. The Nonprescription Drugs Advisory Committee met to discuss the safety and efficacy of these products in children. The committee of experts voted 21-1 that use for kids under 2 should not be recommended for over-the-counter cough and cold products that contain antihistamines, decongestants or antitussives. However, the votes were more divided on the issue of use in children 2-6 years old (13-9). Further, the committee rejected limitation of use of these products in 6-12 year olds by a vote of 15 to 7, even though the committee had agreed there was no evidence that the products do any good for this group of children. The final recommendation from the committee includes the restriction of antihistamine, decongestant or antitussive-containing medications to children above 6 years of age. Also, the committee called for more safety and efficacy studies in children 2 to 6 years old. These recommendations do not translate into formal actions quite yet. Given the recent media attention on FDA decisions, it will be interesting to follow this issue and the agency’s resolution. Asal Sadatrafiei is a fourth-year pharmacy student.
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