Pediatricians Warn FDA on Cold Medicines

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. Cold Drug makers voluntarily pulled cold medicines targeted for babies and toddlers off the market Thursday, leaving parents to find alternatives for hacking coughs and runny little noses just as fall sniffles get in full swing. The move represented a pre-emptive strike by over-the-counter drug manufacturers - a week before government advisers were to debate the medicines' fate. But it doesn't end concern about the safety of these remedies for youngsters. (AP Photo/Paul Sakuma) (Paul Sakuma - AP)

Drug makers instead largely 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. They're also to examine whether the dizzying array of medicines that combine multiple ingredients and the sometimes hard-to-use droppers the packages include contribute to parents unwittingly overdosing their children.

Some panelists seemed reluctant Thursday to believe the claim by petitioners the medicines don't work and are dangerous, citing the volumes in which they are used.

"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 also do so for emotional reasons _ out of fear, vulnerability and caring.

Questions from panelists also touched on what alternatives parents can turn to in seeking care for their sick children.

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

Petitioner Dr. Joshua Sharfstein, Baltimore's health commissioner and a pediatrician had a simple, time-tested answer.

"Love. Liquids. That's what I recommend."