An FDA review of records filed with the agency between 1969 and September 2006 found 54 reports of deaths in children associated with decongestant medicines made with pseudoephedrine, phenylephrine or ephedrine. It also found 69 reports of deaths associated with antihistamine medicines containing diphenhydramine, brompheniramine or chlorpheniramine.
Most of the deaths involved children younger than 2.
On Sept. 28, the FDA announced that the makers of almost 200 unapproved prescription medicines containing the ingredient hydrocodone must cease making these products for children under 6 by Oct. 31.
Hydrocodone, a narcotic, is commonly used to ease pain and cough. According to the Times, many of the children's hydrocodone products currently on the market have been around for decades but never received approval from the modern-day FDA.
For more on cold remedies for children, visit the American Academy of Pediatrics.
SOURCES: Catherine Tom-Revzon, Pharm.D, clinical pharmacy manager, Children's Hospital at Montefiore, New York City; Michael Shannon, M.D., M.P.H., chief, Division of Emergency Medicine, Children's Hospital, Boston; Oct. 18, 2007, statement, Consumer Healthcare Products Association, Washington, D.C.; Sept. 28, 2007, The New York Times; Associated Press
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