WASHINGTON, Jan. 17 (UPI) -- The U.S. Food and Drug Administration has recommended over-the-counter cough and cold products should not be given to children less than 2 years of age.
The FDA, in a public health advisory issued Thursday, said "serious and potentially life-threatening side effects can occur from such use." OTC cough and cold products include decongestants, expectorants, antihistamines, and cough suppressants.
The advisory said there are a wide variety of rare, serious adverse events reported with cough and cold products, including death, convulsions, rapid heart rates, and decreased levels of consciousness.
"The FDA strongly recommends to parents and caregivers that OTC cough and cold medicines not be used for children younger than two," said Dr. Charles Ganley, director of the FDA's Office of Nonprescription Products. He said such medicines that treat symptoms and not the underlying condition have not been shown to be safe or effective in such young children.
The announcement did not include the FDA's final recommendation about use of OTC cough and cold medicines by children ages 2 to 11 years. The agency said its review of data for that group is continuing.
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