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An industry takes its medicine

The Baltimore Sun

Just in time for cold and flu season, manufacturers of popular over-the-counter cold and cough medicines have said they will stop marketing their remedies to children under age 4. It's the industry's latest response to a Baltimore-led push by health experts who note that there's no proof these drugs help young children - but plenty of evidence that they harm kids through overdoses.

The announcement this week by the Consumer Healthcare Products Association is certainly welcome news. Questions persist, however, over whether such statements are sincere, and whether they go far enough. Public hearings last week kicked off what is expected to be a lengthy review of the subject by the Food and Drug Administration.

In January, the FDA urged parents to stop giving these medications to children under age 2, a position the industry association agreed with. The problem has been follow-through. Although medications targeting children under age 2 were pulled from shelves, other products have not been consistently relabeled to warn parents against giving them to babies and toddlers. Baltimore Health Commissioner Dr. Joshua M. Sharfstein and others who have shown leadership on this issue would like the FDA to go further; the American Academy of Pediatrics has concluded that cold and cough remedies are simply not appropriate for children under age 6. As Dr. Sharfstein noted in testimony to the FDA last week, the safety risks of cold remedies are amply documented. The Maryland Poison Center reported 900 overdoses in children under 5 during a single year, 2004. Worse, at least four deaths in recent years of Baltimore children under age 4 were linked to parents giving excessive doses.

It is possible, despite the lack of evidence, that these drugs do provide some modest relief. But the fact is, colds go away on their own. Given the risk of adverse effects and the scant evidence of benefits, the FDA should not rely on the industry's voluntary and thus far imperfect response to this problem; compliance will require monitoring by watchdog groups or government agencies.

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