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FDA to Review Cold Remedies for Kids


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Paul noted that these medications are often marketed for very young children. "The FDA needs to say what the place is for these medicines," he said. "The American Academy of Pediatrics and the American Academy of Chest Physicians have come out and said that some of these medications shouldn't be made available to children."

Popular medicines like Toddlers Dimetapp, Infant Triaminic and Little Colds, which are marketed for use in children as young as 2, should not be given to children younger than 6 under any circumstances, the petition filed Thursday with the FDA said, according to the Times.

The Consumer Healthcare Products Association, which represents the non-prescription over-the-counter drug industry, believes these medicines are safe and effective.

Text Continues Below



"These medicines have been found safe and effective by the FDA and are the same medicines that families have safely relied upon for decades to help relieve cough and cold symptoms and make their children feel better," Linda A. Suydam, president of the Consumer Healthcare Products Association, said in a prepared statement.

"Current FDA assessment of the safety and efficacy of approved children's over-the-counter antitussives, expectorants, nasal decongestants, antihistamines, and combination cough cold products is based on scientific studies in children and/or on extrapolation from extensive data in adults," Suydam added. "This process of extrapolation follows internationally recognized recommendations for diseases which are similar in adult and pediatric patients and applies to the symptoms and conditions for these medicines."

Penn State's Paul said that for children with colds, recommended measures include appropriate doses of acetaminophen or ibuprofen to relieve discomfort. The child should also be kept well hydrated, he said. "For colds, saline nose drops can help. Colds should get better. If they get worse, that's the time to see a doctor," he said.

More information

For more about colds and cold medications for young children, visit the American Academy of Pediatrics.

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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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