An FDA advisory panel is scheduled to consider the recommendation during a meeting on Oct. 18 and 19, and will then offer an opinion to the full agency. The FDA typically follows the recommendations of its advisory boards but is not required to do so.
In the safety review released Sept. 28, the FDA experts recommended that all infant cough and cold products be removed from the market. They also recommended that the sizes of the droppers, cups and syringes packaged with products be standardized to reduce the possibility of confusion and overdose, The New York Times reported.
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, the Associated Press reported.
Most of the deaths were children younger than 2.
The Consumer Healthcare Products Association, which represents makers of over-the-counter medicines, said it and its member companies have put forth recommendations to the FDA to strengthen the labels on all oral OTC children's cough and cold medicines from "ask a doctor" before using to "do not use" in children under 2 years of age.
To learn more about the voluntary withdrawal, visit the Consumer Healthcare Products Association.
SOURCES: Oct. 11, 2007, prepar
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