Pediatricians press FDA on safety of cold medicines for children under 6

WASHINGTON — Cold and cough medicines recently pulled from sale for infants and toddlers shouldn't be given to children as old as 5, either, pediatricians told government health advisers Thursday.

The expert advisers to the Food and Drug Administration began a two-day meeting to consider a petition from the pediatricians that seeks in part a government statement saying the over-the-counter medicines shouldn't be used in children under 6 because they don't help them and aren't safe.

The FDA has yet to act on the petition, in part pending a recommendation expected late Friday from the joint panel of outside experts in pediatrics and nonprescription drugs, said the agency's Dr. Joel Schiffenbauer.

The meeting opens a week after drug makers pulled from sale oral cough and cold medicines for children under 2. The drug industry maintains the widely used medicines are safe and work but can lead to overdoses when misused in infants.

However the petitioners, including Baltimore city health officials, argue that the medicines not only don't work in children up to age 6 but that they can be dangerous as well.

"Are there safe and effective therapies for the common cold?" asked panelist Dr. Ruth Parker, an Emory University School of Medicine professor.

"Love. Liquids. That's what I recommend," said petitioner Dr. Joshua Sharfstein, Baltimore's health commissioner and a pediatrician.

While the medicines have been marketed for use in children for decades — ad spending now is roughly $50 million a year — it has long been acknowledged there is negligible or no data from studies in the very young to show they are safe and work. Worse, some studies suggest the medicines are no better than dummy pills in treating cold and cough symptoms in young children, the petitioners said.

"When a treatment is ineffective, its risks — if not zero — always will exceed its benefits," said Dr. Michael Shannon, a Children's Hospital Boston pediatrician and Harvard Medical School professor who was another of the petitioners.

The drugs — they include some Dimetapp, Pediacare, Robitussin and Triaminic products — have never been tested in children, which a previous FDA panel noted as long ago as 1972. Drug makers instead have used extrapolated data from studies in adults to come up with dosing recommendations based on a child's age or size.