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Drug Makers Withdraw Cough, Cold Meds for Infants
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Page: << Prev | 1 | 2 Last month, U.S. health experts urged the federal Food and Drug Administration to consider banning the sale of over-the-counter cough and cold medicines for young children. The recommendation, from FDA safety officials, would apply to decongestant use in children under 2, and antihistamines in those younger than 6, according to FDA documents.
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.
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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 involved children younger than 2.
Dr. Daniel Rauch, director of New York University Medical Center's Pediatric Hospitalist Program, said the manufacturers' decision to withdraw the drugs "confirms multiple years of evidence that these medications don't work and are potentially dangerous. When parents think these medications will work, and they don't, the natural response is to give an infant more medication, leading to potentially dangerous side effects. Kids get sick, and parents need to realize it will pass."
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.
More information
To learn more about the voluntary withdrawal, visit the Consumer Healthcare Products Association.
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Copyright © 2007 ScoutNews, LLC. All rights reserved.
Last updated 10/11/2007
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SOURCES: Oct. 11, 2007, prepared statement, Consumer Healthcare Products
Association, Washington, D.C.; Catherine Tom-Revzon, Pharm.D, clinical pharmacy manager, Children's Hospital at Montefiore, New York City; Daniel Rauch, M.D., FAAP, director of the Pediatric Hospitalist Program, New York University Medical Center, and associate professor of pediatrics, New York University School of Medicine, New York City; Sept. 28, 2007, U.S. Department of Health and Human Services report; The New York Times; Associated Press
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