Dodd Asks FDA to Change OTC Cough and Cold Product Labels

A veteran senator and presidential candidate is calling on the FDA to take swift action to adopt advisory committees’ recommendations limiting the use of OTC cold and cough medicines in children younger than 6.

Agency officials have urged parents to continue following labeling directions on the products although the drugs’ efficacy and safety has not been established, Sen. Chris Dodd (D-Conn.) said in a letter to FDA Commissioner Andrew von Eschenbach.

The FDA’s Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee recently recommended that OTC cough and cold medicines not be given to children younger than 6.

There is no evidence the OTC products are effective in young children, but there are reports of injury and death in children taking the products, Dodd said.

The FDA should update labeling information immediately as it does with information from clinical trials conducted under the Best Pharmaceuticals for Children Act, Dodd said. He requested updates on the agency’s plan for acting on the advisory committees’ recommendations.

Dodd’s letter can be seen at dodd.senate.gov/index.php?q=node/4115.