FDA Says Over-the-Counter Med Need Further Study
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. (Paul Sakuma/AP Photo)
WASHINGTON – Cold and cough medicines don’t work in children 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, expectorants, antihistamines and antitussives.
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.
In two separate votes, 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 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. The process could take years, even before any studies themselves get under way.
Simply relabeling the medicines to state they shouldn’t be used in some age groups could be accomplished more quickly, FDA officials said.
Indeed, the drug industry could further revise the labels on the medicines to caution against such use. 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.
Government Advisers: Don’t Use Cold Medicines in Children Under 6