The U.S. Food and Drug Administration issued a Public Health Advisory for parents and caregivers, recommending that over-the-counter (OTC) cough and cold products should not be used to treat infants and children less than 2 years of age because serious and potentially life-threatening side effects can occur from such use. OTC cough and cold products include decongestants, expectorants, antihistamines, and antitussives (cough suppressants) for the treatment of colds.
There are a wide variety of rare, serious adverse events reported with cough and cold products. They include 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 2,” said Charles Ganley, M.D., director of the FDA’s Office of Nonprescription Products. “These medicines, which treat symptoms and not the underlying condition, have not been shown to be safe or effective in children under 2.”
Release date: January 17, 2008
Source: US Food and Drug Administration
Filed Under: Drug Discovery