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The medicines long used by parents to treat their children's coughs and colds don't work and shouldn't be used in those younger than 6, federal health advisers recommended Friday.
The over-the-counter medicines should be studied further, even after decades in which children have received billions of doses a year, the outside experts told the Food and Drug Administration. The FDA isn't required to follow the advice of its panels of outside experts but does so most of the time.
"The data that we have now is they don't seem to work," said Sean Hennessy, a University of Pennsylvania epidemiologist, one of the FDA experts gathered to examine the medicines sold to treat common cold symptoms. The recommendation applies to medicines containing one or more of the following ingredients: decongestants, antihistamines and antitussives. It doesn't apply to expectorants, though many of the medicines also contain that ingredient.
The nonbinding recommendation is likely to lead to a shake up in how the medicines - which have long escaped much scrutiny - are labeled, marketed and used. Just how and how quickly wasn't immediately clear.
"If the agency chose to restrict use in children 6 and under, that won't necessarily lead to a ban on the products. It might lead to labeling that says 'do not use,'" said Dr. John Jenkins, director of the FDA's office of new drugs.
Such labeling changes could take years to put in place, since the FDA would have to undertake a lengthy rule-making process. Jenkins suggested if the drug industry took it upon itself to make such changes, the FDA could use its enforcement discretion to allow it to do so more quickly than would be done otherwise.
In fact, the Thursday-Friday meeting came just a week after the industry pre-emptively moved to eliminate sales of the nonprescription drugs targeted at children under 2.
So what are parents to do if they chose to use the medicines, pending further action? Jenkins recommended they follow the directions when giving the medicines to their children, and use them only as directed. He also counseled they pay close attention to what ingredients the medicines contain and to ask a doctor if they have any questions.
In two separate votes Friday, the panelists said the medicines shouldn't be used in children younger than 2 or in those younger than 6. A third vote, to recommend against use in children 6 to 11, failed.
Earlier, the panelists voted unanimously to recommend the medicines be studied in children to determine whether they work. That recommendation also would require the FDA to undertake a rule-making process to reclassify the medicines, since the ingredients they include are now generally recognized as safe and effective, which doesn't require testing. Again, that process could take years, even before any studies themselves get under way.
The panel's advice dovetails with a petition filed by pediatricians that argued the over-the-counter medicines shouldn't be given to children younger than 6, an age group they called the most vulnerable to potential ill effects. The American Academy of Pediatrics and other groups back the petition.
But FDA officials and panelists agreed there's no evidence they work in older children, either. Still, panelists held off from recommending against use in those 6 and older. And some said they feared such a prohibition wouldn't eliminate use of the medicines by parents.
"They will administer adult products to their children because they work for them or feel they work for them," said the panel's patient and family representative, Amy Celento of Nutley, NJ
The drug industry says the medicines, used 3.8 billion times a year in treating cold and cough symptoms in children, do work and are safe.
"We worked very hard to present data to the panel and in some cases I felt as though they didn't listen and when you are in that position, it's tough," Linda Suydam, president of the Consumer Healthcare Products Association, the trade group that represents over-the-counter medicines, told reporters. Suydam pledged the industry would study the medicines as recommended and try harder to educate parents to avoid overdoses that in rare cases have been fatal.
Some of the drugs - which include Wyeth's Dimetapp and Robitussin, Johnson & Johnson's Pediacare and Novartis AG's Triaminic products - have never been tested in children, something flagged as long ago as 1972 by a previous FDA panel.
An FDA review found just 11 studies of children published over the last half-century. Those studies did not establish that the medicines worked in those cases, according to the agency.
For the most part, the results from tests in adults have been extrapolated to determine whether the medicines work in children. But even that evidence is "modest at best," said panel chairwoman Dr. Mary Tinetti of Yale University School of Medicine. Indeed, all but one of the 22 panelists then voted to say that extrapolation is unacceptable.
The panel also recommended drug makers provide standardized droppers with their liquid cough and cold medicines. Experts had told the panel the sometimes hard-to-use dosing devices contribute to parents unwittingly overdosing their children.
Later Friday, the panel recommended the dizzying array of medicines that combine multiple ingredients remain on the market - but only pending the results of future studies to determine whether they work.
The panel also said cold and cough medicines should not be allowed to bear "doctor-recommended" and similar statements. It wasn't immediately clear if such a prohibition would be constitutional.
One health expert told the panel that children catch five to eight colds each year. Those colds don't necessarily require treatment beyond comfort measures that don't involve drugs, said Patricia Jackson Allen, of the National Association of Pediatric Nurse Practitioners.
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