Concentrated Tylenol Infants' Drops Plus Cold & Cough, Pedia Care Infant Drops Long-Acting Cough
Paul Sakuma  /  AP file
Over-the-counter cold medicines have never been tested in children. The Food and Drug Administration is meeting to decide whether they should be used for children 5 and younger.
updated 10/18/2007 8:04:40 PM ET 2007-10-19T00:04:40

Cold and cough medicines given to infants and toddlers work no better than dummy pills and can be dangerous, pediatricians seeking to curb their use told government health advisers Thursday.

The doctors told the Food and Drug Administration advisers that the over-the-counter medicines should not be given to children younger than 6 years old because they do not help them, and they are not safe. Such a prohibition would go beyond last week's drug industry move to eliminate sales of the nonprescription drugs targeted at children under 2.

The group petitioned the FDA, seeking in part a government statement that medications should not be used in older children as well. The expert advisers began a two-day meeting to consider the issue. The FDA has yet to act, 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 medicines have been marketed for use in children for decades, with drug companies spending $50 million (euro35 million) a year on heart-tugging ads in parenting magazines and elsewhere. Still, it has long been acknowledged that little or no data exists from studies in the very young to show whether the medicines 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.

Risks outweigh benefits
"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, another of the petitioners.

The drug industry, meanwhile, maintains the widely used medicines are safe and work but can lead to death and injury from overdoses or misuse in infants. It estimates children receive 3.8 billion doses of the medicines a year.

"The vast majority of consumers are using these medicines properly and serious adverse events are rare," said Linda Suydam, president of the Consumer Healthcare Products Association, which represents makers of over-the-counter drugs.

The meeting opened a week after drug makers pulled from sale oral cough and cold medicines for children under 2. The labels on those medicines had recommended parents "ask a doctor" before giving them to children that young. That advice seemingly did little to rein in their use.

"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.

The drug industry now says simply that the medicines should not be used in that age group. The petitioners are pushing to expand that to those under 6.

Some of the drugs, which include Wyeth's Dimetapp and Robitussin, Johnson & Johnson's Pediacare and Novartis AG's Triaminic products, never have been tested in children, which a previous FDA panel noted as long ago as 1972.

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"Studies in children are few and sparse," said Lolita Lopez, an FDA pediatrician, noting a review found just 11 published over the last half-century. Those studies did not establish that the medicines worked, Lopez said.

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 is evidence that the drugs work in children up to age 12. They also are 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 do not 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 do so for emotional reasons out of fear, vulnerability and caring.

Questions from panelists also touched on alternatives that 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."

The Associated Press and Reuters contributed to this report


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