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Toddlers' Cold Drugs Hurt More Than Help, Doctors Say

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The Associated Press

Published: October 19, 2007

WASHINGTON - Cold and cough medicines given to infants and toddlers work no better than dummy pills and can be dangerous, pediatricians seeking to curb their use told government health advisers Thursday.

The doctors told Food and Drug Administration advisers that over-the-counter medicines shouldn't be given to children younger than 6 because they don't help them and aren't safe. Such a prohibition would go beyond last week's drug industry move to eliminate sales of the nonprescription drugs targeted at children under 2.

The group petitioned the FDA seeking in part a government statement saying the medications shouldn't be used in older children as well. The expert advisers began a two-day meeting to consider the issue.

The FDA has yet to act, in part pending a recommendation expected late today from the joint panel of outside experts in pediatrics and nonprescription drugs, the agency's Joel Schiffenbauer said.

The medicines have been marketed for use in children for decades, with drug companies spending $50 million a year on ads in parenting magazines and elsewhere. Still, it has long been acknowledged there are little or no data from studies in the very young to show the medicines are safe and work. Worse, some studies suggest the medicines are no better than dummy pills in treating cold and cough symptoms in young children, the petitioners said.

'When a treatment is ineffective, its risks - if not zero - always will exceed its benefits,' said Michael Shannon, a Children's Hospital Boston pediatrician and Harvard Medical School professor who was one of the petitioners.

The drug industry maintains the widely used medicines are safe and work but can lead to death and injury from overdoses or misuse in infants.

'The vast majority of consumers are using these medicines properly and serious adverse events are rare,' said Linda Suydam, president of the Consumer Healthcare Products Association, which represents drug makers.

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