US health agency FDA is 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.
The U.S. Food and Drug Administration has issued a Public Health Advisory for parents and caregivers. 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.”
The announcement does not include the FDA’s final recommendation about use of OTC cough and cold medicines in children ages 2 to 11 years. The agency’s review of data for 2-to-11-year-olds is continuing. The FDA is committed to making a timely and comprehensive review of the safety of OTC cough and cold medicines in children. The agency plans to issue its recommendations on use of the products in children ages 2 to 11 years to the public as soon as the review is complete.
The FDA recommends that anyone with questions contact a physician, pharmacist or other health care professional to discuss how to treat a child with a cough or cold.
Source: U.S. Food and Drug Administration, USA