FDA's Office of Pediatric Therapeutics (OPT) maintains a Safety Reporting page with information on products that have been tied to safety problems that specifically relate to children. This page lists products that have been the subject of an adverse event report presented to FDA’s Pediatric Advisory Committee, a group of outside experts that advises the agency on pediatric treatments, research and labeling. (An adverse event is any undesirable experience associated with a medical product.) The committee’s recommendation is also given if further actions were necessary to ensure safe use of the product in children.
View the OPT Safety Reporting page
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