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Medical News & Perspectives
February 27, 2008

Citing Serious Risks, FDA Recommends No Cold and Cough Medicines for Infants

JAMA. 2008;299(8):887-888. doi:10.1001/jama.299.8.887

Children younger than 2 years old should not be given over-the-counter cold and cough medicines, warned the US Food and Drug Administration (FDA) after 3 months of deliberations. The agency continues to contemplate whether these products should be used in children aged 2 through 11 years.

In October, the FDA began weighing the safety and efficacy of over-the-counter cold and cough medicines for children following reports of severe adverse reactions and even deaths in infants and children. At the time, the agency's Nonprescription Drugs and Pediatric Advisory Committees recommended that these products not be given to infants and children younger than 6 years, citing a lack of safety and efficacy data in these very young children. That same month, many drug companies voluntarily recalled dozens of cold and cough products that targeted children younger than 2 years.