FDA: Cold medicines too risky for tots
Updated: 2008-01-17 17:01
WASHINGTON - Parents may be left with only love and lots of liquid to give their sniffling babies and toddlers now that the government is declaring over-the-counter cough and cold medicines too risky for tots.
The Food and Drug Administration was issuing that warning Thursday to parents of children under 2.
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Pedia Care Infant Drops Long-Acting Cough and Concentrated Tylenol Infants' Drops Plus Cold & Cough are shown in a medicine cabinet at the home of Carol Uyeno in Palo Alto, Calif., in this Oct. 11, 2007 file photo. Parents should not give babies and toddlers over-the-counter cough and cold medicines — they're too risky for tots so small, the government will declare Thursday. [Agencies] |
It's a move expected for months: Drug companies last October quit selling dozens of versions of nonprescription cold remedies targeted specifically to babies and toddlers. That month, the FDA's scientific advisers also voted that the drugs don't work in small children and shouldn't be used in preschoolers, either — anyone under age 6.
The FDA still hasn't decided if OTC decongestants, antihistamines and cough suppressants are appropriate for older children, officials told The Associated Press. Expect a decision on that by spring, the deadline necessary to notify manufacturers before they begin production for next fall's cold season.
For now, FDA's first official ruling focuses on youngsters under 2, warning that "serious and potentially life-threatening side effects can occur."
FDA is worried that parents haven't gotten that message despite all the publicity last fall. They may still have infant-targeted drugs at home, or they may buy drugs meant for older children to give to tots instead, said Dr. Charles Ganley, FDA's nonprescription drugs chief.
"We still have a concern," Ganley said. "It falls out of people's consciousness. We're still in the middle of cold season right now."
Ganley was particularly struck by recent surveys that suggest many parents don't believe OTC remedies could pose a problem, especially if they've given them to an older child without harm.
Thursday's move is a good first step, said Dr. Joshua Sharfstein, Baltimore's health commissioner. He petitioned the FDA last year to end use of nonprescription cold remedies by children under 6, a move backed by the American Academy of Pediatrics.
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