Statement on Food and Drug Administration Announcement on
Over-the-Counter Cough and Cold Medications for Children
Dr. Joshua M. Sharfstein, Commissioner of Health, released the following statement in response to FDA's announcement of a new rulemaking on over-the-counter cough and cold medications for young children:
“The FDA's announcement today is a significant step towards removing unproven and unsafe over-the-counter cough and cold medications for young children from the market. By re-opening the relevant regulation, FDA will hold these products to a modern scientific standard of safety and effectiveness. It is clear that these products cannot meet such a standard today. FDA should move swiftly through this process to protect children.”
“Leading professional organizations, including the American Academy of Pediatrics and the National Association of Pediatric Nurse Practitioners, advise against use of cough-and-cold medications for young children. Manufacturers should respect these professional authorities, recognize the significance of FDA's action today, and voluntarily stop marketing these products to parents of young children as safe, effective, and ‘pediatrician recommended.’”
“As the cold season approaches, parents should save their money and talk to their doctors and nurses about how to make their children comfortable with a cough or cold.”
[Press Release] [FDA's Announcement] [Health Department Original Research on Over-the-Counter Cough and Cold
Medications Published Since the October 2007 FDA Advisory Statement] |
