Debate Continues Over the Safety of Cold and Cough Medicines for Children

Abstract

IN THE WAKE OF CALLS FOR THE US Food and Drug Administration (FDA) to discourage the use of cold and cough medicines for children younger than 6 years, the makers of such products have agreed to change the products’ labels, the second labeling change in about a year. In October, the Consumer Healthcare Products Association (CHPA), a group that represents the manufacturers of over-the-counter cold and cough products, announced that its members would voluntarily revise the labels of children’s cold and cough medicines to indicate that the products should not be used in children younger than 4 years. The group also added a warning to the label of products containing antihistamines that they should not be used to sedate children. The announcement came within days of an October 2 hearing hosted by the FDA in which many physicians, public health officials, and consumer advocates urged the agency to take action to prevent the marketing of these medicines to children, particularly those younger than 6 years. The agency supported the industry’s proposal to relabel the products. The agency said it will continue its review of the safety of cold and cough medicines for children of all ages. Although the FDA has been criticized for the pace of its review of these products, John Jenkins, MD, director of the FDA’s Office of New Drugs, said the agency is concerned that removal of all children’s cold and cough products from the market could have unintended negative consequences, such as the possibility that some parents might give their children adult cold and cough products instead.