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Some Toddler Deaths From Cold Drugs Linked to Abuse (Update1)

By Rob Waters

Dec. 18 (Bloomberg) -- Some of the 103 children who died after taking over-the-counter cough medicines may have been deliberately given overdoses to sedate or even kill them, expert reviewers found in a study of deaths the past four decades.

The children who died after taking the drugs ranged in age from 28 days to 10 years, with 75 percent younger than 2. In 26 cases, the panel of reviewers determined that a child was given the medication with “nontherapeutic intent.” Ten died in day- care facilities, the study found.

Experts advising the U.S. Food and Drug Administration urged in October 2007 that non-prescription cold and cough medicines not be given to children younger than 6. Drugmakers voluntarily withdrew infant formulas and in October this year changed the labels on the medicines to warn against their use in children younger than 4. Those measures, while important, won’t protect children whose caregivers administer overdoses to sedate or quiet them, said Richard Dart, the lead author of the study, published today in the Annals of Emergency Medicine.

“The whole discussion has been portrayed as innocent parents giving their kids medicine and their child is dead,” Dart said in a telephone interview today. “We’re not saying the confused parent who gives an overdose accidentally isn’t important. It is, and we should protect them. But we shouldn’t forget that a significant portion of these cases is not going to be addressed” by the label changes.

Missing Cases

Dart said the number of children who died from cold medications were probably much higher than analyses based on death reports from the mid-1960s to 2007. The reports were drawn from poison control agencies, the FDA and drug companies.

“Undoubtedly we missed a large number of other deaths,” he said. Dart is the director of the Rocky Mountain Poison and Drug Center in Denver.

The research was supported by funding from McNeil Consumer Healthcare, a unit of New Brunswick, New Jersey-based Johnson & Johnson that makes over-the-counter cold medicines. McNeil was among the companies that withdrew several products aimed at infants last year.

Dart began the investigation after he looked into the death several years ago of two children who died after their father, a taxi driver, gave them cold medicine to quiet them so he could sleep. The study listed 10 deaths as suspected homicides.

Another 10 deaths in day-care centers may have been due to poorly trained child-care workers using the medication to control behavior. In some cases, he said, children drank the medication out of a glass, instead of a small dropper.

“Presumably these centers are not trying to kill their own clients,” Dart said. “They’re doing stupid things out of ignorance. These are over-the-counter products and I think people don’t recognize the risks.”

Dart and his colleagues recommended in their study that the directions on non-prescription cold and cough medicines “clearly advise against use of these products for sedation.”

To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net.

Last Updated: December 18, 2008 20:50 EST