Doctors Press FDA On Cold Meds For Kids

Concentrated Tylenol Infants' Drops Plus Cold & Cough, right, and Pedia Care Infant Drops Long-Acting Cough, left, is shown in a medicine cabinet of the home of Carol Uyeno in Palo Alto, Calif., Thursday, Oct. 11, 2007.
AP
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 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, 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.

CBS News correspondent Wyatt Andrews reports that the cold and cough medicine industry admits that 92 deaths are connected to combination cold medicines - but claims 79 of them were due to misuse or overdose.

Drug manufacturers continue to maintain that administered correctly, the medicines are safe and effective for sick children over two years of age.

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.

While the focus of the petition and the FDA is on children under 6, the joint panel of experts will be asked if there's evidence that these drugs work in children up to age 12.

The medicines are widely used, with an estimated 95 million packages sold for infant and toddler use each year.

"If these medicines are allegedly not effective or materially unsafe, how is the purchase of millions, hundreds of millions, of doses by parents explained?" asked Dr. George Goldstein, the panel's nonvoting industry representative.

Dr. Dan Levy, president of the Maryland chapter of the American Academy of Pediatrics, said parents buy the medicines for their children because they want quick results. Earlier, Levy also said parents buy the medications for emotional reasons, out of fear, vulnerability and caring.

The recently pulled medicines had recommended parents "ask a doctor" before giving them to children under 2.

"We all have a lot of friends who call up their pediatricians and the pediatricians tell them to take the drugs," said panelist Ralph D'Agostino, a Boston University public health and statistics expert.

Other doctors aren't so quick to give parents the green light. Andrews asked Baltimore pediatrician Dr. Daniel Levy for his perspective.

"How do I advise parents to dose these medications?" Levy responded. "I ask them to unscrew the top of the bottle and in one easy motion, invert it over the toilet."