Senator calls for FDA ban on sale of cough-cold medicines for children under six

WASHINGTON Sen. Chris Dodd, D-Conn., senior member of the Senate Committee on Health, Education, Labor, and Pensions and chair of its subcommittee on Children and Families, earlier this week called on the Food and Drug Administration to ban the marketing of children’s cough-cold formulations for children under six even as industry made the announcement they would no longer market use of those medicines to children under four years of age.

“While I’m pleased to see that the drug companies are voluntarily taking some steps to ensure the safety and well being of our children, I am disappointed that the FDA has not followed the recommendations of its own advisory panel,” stated Dodd.  “I strongly urge the FDA to take swift action to ensure the safety and efficacy of these products in young children before one more child is given a medicine that may not only be ineffective but could also be harmful.”

In a letter to FDA commissioner Andrew von Eschenbach, Dodd wrote, “Nearly a year has passed since the FDA’s Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee voted 13 to 9 against the use of over-the-counter cough and cold medications in children ages two to six. Another cold and flu season is right around the corner, yet commonly available medical products continue to be marketed and sold to the parents of young children even though they have not been shown to be effective and experts have raised serious questions about their safety.”