The Wall Street Journal-20080117-FDA Warns Cold Drugs Are Too Risky for Babies
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FDA Warns Cold Drugs Are Too Risky for Babies
Associated Press
WASHINGTON -- Parents shouldn't give babies and toddlers over-the- counter cough and cold medicines because they are too risky for children so small, the government will declare today.
The Food and Drug Administration still hasn't decided if the remedies are appropriate for older children to continue using, officials told the
Expect a decision on that by spring, the deadline necessary to notify manufacturers before they begin production for next fall's cold season.
The FDA is issuing a public health advisory today to warn parents to avoid these drugs for children under age 2 "because serious and potentially life-threatening side effects can occur."
It isn't the first warning about cold remedies and tots: Drug companies last October quit selling dozens of versions targeted to babies and toddlers. That same month, the FDA's own scientific advisers voted that the drugs don't work in small children and shouldn't be used in anyone under age 6.
Today's advisory marks the government's first official ruling on the issue: Don't give the drugs to children under 2. And it comes now because the FDA is worried that parents haven't gotten that message despite 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 Charles Ganley, the FDA's nonprescription drugs chief.
Dr. Ganley said he is concerned by recent surveys that suggest many parents don't believe over-the-counter cold remedies could pose a problem, especially if they have used them with an older child who seemed to get better.
