Cold and cough medicines given to infants and toddlers work no better than dummy pills and can be dangerous, according to pediatricians who are seeking to curb the use of these meds. Instead, one doctor on hand for a closely watched two-day FDA advisory committee meeting, which continues today, recommends something more basic for treating the common cold - love and liquids.

The docs told the FDA panel yesterday that the OTC meds shouldn’t be given to children younger than 6 because they don’t help them and aren’t safe, the Associated Press reports. Such a prohibition would go beyond last week’s 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 saying the meds shouldn’t be used in older children as well. The FDA hasn’t yet acted, and is waiting on a recommendation expected later today from the advisory committee, the AP writes.

The meds have been marketed for use in children for decades, with drugmakers spending $50 million a year on heart-tugging ads in parenting magazines and elsewhere. But it’s long been acknowledged there are little or no data from studies in the very young to show the meds are safe and work. And some studies suggest the meds are no better than dummy pills in treating cold and cough symptoms in young children, the docs say.

“When a treatment is ineffective, its risks, if not zero, always will exceed its benefits,” says Michael Shannon, a Children’s Hospital Boston pediatrician and Harvard Medical School professor who was another of the petitioners.

The drug industry, meanwhile, maintains the widely used meds 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,” says Linda Suydam, president of the Consumer Healthcare Products Association, which reps OTC drugmakers.

The meeting opened a week after drugmakers pulled from sale oral cough and cold meds for children under 2. The labels on those meds had recommended parents “ask a doctor” before giving them to children that young - advice that 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,” says panelist Ralph D’Agostino, a Boston University public health and statistics expert.

The drug industry now says simply that the meds shouldn’t be used in that age group. The petitioners, including Baltimore city health officials, 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 Triaminic products, have never been tested in children, which a previous FDA panel noted as long ago as 1972. “Studies in children are few and sparse,” says Lolita Lopez, an FDA pediatrician, noting a review found just 11 published over the last half-century and those studies didn’t establish the meds work. Instead, drugmakers 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 advisory panel will be asked if there’s evidence the meds 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 yesterday to believe the claim by petitioners the meds 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 George Goldstein, the panel’s nonvoting industry rep. (Our two cents: George, maybe industry marketing helped).

Dan Levy, president of the Maryland chapter of the American Academy of Pediatrics, says parents buy the meds for their children because they want quick results, and they 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 Ruth Parker, an Emory University School of Medicine professor.

Petitioner Dr. Joshua Sharfstein, Baltimore’s health commissioner and a pediatrician offered a simple, time-tested answer: “Love. Liquids. That’s what I recommend.”

Source: The Associated Press