The Food and Drug Administration today warned parents not to give small children over the counter cold medications.
The FDA warning says OTC cold meds 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 FDA says:
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.
