The debate continues about cough and cold medicines in young children. Last year, a group of pediatricians petitioned the FDA to remove approval for children less than 6 years old. The industry voluntarily took these products off the market for children less than 2 years old. Then the FDA’s official advisory panel on this issue voted to recommend that the products not be used in children less than 6 years old. The FDA later acted to officially state that these products should not be used in children less than 2. As part of the FDA’s ongoing review of this issue, a public comment meeting was held last week. Although no official announcement was made, the FDA appears unwilling to act on its own advisory panel’s recommendation at this time. However, right after the meeting the industry agreed to voluntarily ban all products for use in children less than 4 years old.
There is no evidence that cough and cold medicines are effective in children less than 6 years old, and their effectiveness is questionable in children less than 12. Moreover, they have clearly caused injuries and contributed to deaths in children less than 2 years old. Since they have not been shown to be effective, and can be dangerous, there continues to be no reason to use them in young children.
FDA Consumer Update: Using Over-the-Counter Cough and Cold Products in Children October 22, 2008
