FDA to Review Cold Remedies for Kids

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The CDC had identified three infants who died from the toxic effects of cough and cold medicines in 2005. In addition, in 2004 and 2005, more than 1,500 children younger than 2 years old were treated in emergency rooms for adverse events from cough and cold medicines, the report said.

The report also noted that although these drugs are effective in older children and adults, there's little evidence the medications help in children under 2 years old. "Parents should always consult a health-care provider before giving cough or cold medicine to kids under 2 years old. Health-care providers should use caution when giving cough and cold medicines to children under 2 years old," the report concluded.

One expert said these medications are ineffective and are potentially dangerous for young children, and the FDA needs to decide whether these medicines should be available or not.

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"These medicines have not been adequately tested on young children," said Dr. Ian M. Paul, an assistant professor of pediatrics and health evaluation sciences at Penn State College of Medicine and a spokesman for the American Academy of Pediatrics.

"These medications have not been shown to be effective," Paul added. "The doses have been made up and extrapolated from adult doses, and particularly with high doses, parents often mis-dose, and these medicines have the potential to be dangerous."

Another expert agreed that the FDA needs to carefully assess the safety and benefits of these medicines.

"Taking a careful look at these medications to judge their safety, efficacy and appropriate use is a long time coming," said Dr. Michael Marcus, the director of pediatric pulmonology, allergy and immunology at the Maimonides Infants & Children's Hospital, in New York City.

"The FDA should mandate that for these drugs to be on the market, there should be some good scientific studies that would prove their safety and efficacy, no different than any other medication," Marcus said. "It may be reasonable to make these drugs available by prescription."

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