WASHINGTON — 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 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.
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.
The panel also recommended that drugmakers 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.
The panel also said cold and cough medicines should not be allowed to bear “doctor-recommended” and similar statements.
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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