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FDA urged to reverse okay of lollipop drug

A panel of scientists, torn between doctors' pleas for help and a mother's tearful story of her son's death, is trying to figure out how to get safe but potent painkillers to children about to undergo medical treatment.

No sedatives or painkillers have been proven safe for children. The only such product approved by the Food and Drug Administration is a "narcotic lollipop" called Oralet that isn't on the market.

Commissioner David Kessler on Tuesday heard doctors testify how they brew dangerous cocktails of adult drugs for children because they have no alternative. An FDA advisory committee is spending two days trying to decide how Oralet and future children's painkillers can be safely used.

Nobody knows how many children die from these painkillers because doctors are not required to report problems. Some doctors do voluntarily; the FDA discovered 133 cases where children died or were disabled or hospitalized.

Donna Schilling's 17-year-old son died after his wisdom teeth were removed. The dentist gave him a patch called Duragesic that delivered high doses of the painkiller Fentanyl through the skin.

Fentanyl is an adult drug meant for chronic pain sufferers. It was never intended for children, but many pediatricians administer it in intravenous form.

A company recently won FDA approval for Oralet, a raspberry-flavored form of the drug.

But Dr. John Ryan of Harvard University said Oralet has drug doses 12 to 25 times lower than Duragesic. Oralet is needed, he said, because it enables children to get relief without undergoing a shot, an enema or an inhalant of adult drugs.

Dr. Sidney Wolfe of the Public Citizen consumer advocacy group asked the FDA to reverse approval of Oralet. He cited evidence showing that when given various doses, children are at risk of respiratory arrest and pre-surgical vomiting.

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