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FDA to Review Cold Remedies for Kids
Some doctors say the drugs can be dangerous, particularly for the very young
By Steven Reinberg
HealthDay Reporter
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FRIDAY, March 2 (HealthDay News) -- U.S. health officials said Friday that they are reviewing the safety of children's over-the-counter cold and cough remedies.
Dr. Charles Ganley, the FDA's director of the Office of Nonprescription Products, said the agency has been "looking into the issue of safety of children's cough medicine since the middle of last year." He noted that when these medicines were originally approved, in some cases several decades ago, there was no mandate that the effectiveness, safety or dose be determined for children; rather, the guidelines were extrapolated from studies done with adults.
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"We have not established a dose that is safe for children 2 and under," Ganley said during a teleconference. "We hope to have our review done in several months and then make recommendations."
When these drugs are taken in higher-than-normal doses, they can affect the heart's electrical system, leading to arrhythmias, which are irregular heartbeats. Some medicines affect the blood vessels and, in high doses, have been associated with high blood pressure and stroke. In rare cases, children have been injured even when given recommended doses, The New York Times reported.
On Thursday, a group of prominent pediatricians and public health officials petitioned the FDA to stop drug makers from marketing cold and cough medicines for children under 6. The petition said the medicines do not work and, in rare cases, can cause serious injury.
When the FDA initially approved the drugs for pediatric use, it had determined they were safe and effective for children ages 6 to 12, Ganley said. The agency is looking at data from newer studies to see if the drugs are effective, he said.
In the Jan. 12 issue of the U.S. Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report, researchers noted that cough and cold medicines can be harmful and should be used with caution in children under 2 years of age.
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Copyright © 2007 ScoutNews, LLC. All rights reserved.
Last updated 3/2/2007
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SOURCES: Ian M. Paul, M.D., M.Sc., assistant professor of pediatrics and health evaluation sciences, Penn State College of Medicine, Hershey, Pa.,, and spokesman, American Academy of Pediatrics; Michael Marcus, M.D., director of pediatric pulmonology, allergy and immunology at the Maimonides Infants & Children's Hospital, New York City; March 2, 2007, statement, Consumer Healthcare Products Association, Washington, D.C.; U.S. Centers for Disease Control and Prevention, Atlanta; March 2, 2007, teleconference with Charles Ganley, M.D., director of the Office of Nonprescription Products, U.S. Food and Drug Administration
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