FDA reevaluating pediatric cough and cold remedies
FDA reevaluating pediatric cough and cold remedies
On August 22, 2008, the Food and Drug Administration (FDA) announced plans to revise standards for over-the-counter (OTC) cough and cold medications for children. Many of these nonprescription cough and cold drug products are marketed under the OTC Drug Review, which established a monograph describing the conditions under which certain OTC ingredients are generally recognized as safe and effective. The FDA will hold a public hearing on October 2, 2008 to address a series of questions including: What types of studies should be done to evaluate the products? Should the products remain available without a prescription? How should the doses be determined? Should products that combine different ingredients remain available?
The FDA announcement is the latest response to a petition filed in March 2007 by a group of pediatricians asking the FDA to restrict the use of the products, citing a lack of evidence that they work and mounting evidence they can cause hallucinations, seizures, trouble breathing, heart problems and other complications, including occasionally deaths.
Manufacturers of the cough and cold products are not planning on voluntarily removing the products from the market, as these agent provide relief to old children when used according to product labeling.
Source: The Food and Drug Administration and the Chicago Tribune