Click to play videoNew Delhi: The Food and Drug Administration has issued a public advisory warning parents and caregivers against giving children under the age of two over-the-counter cold medicine and cough syrup because of the possibility of "serious and potentially life-threatening" side effects.
The advisory cited decongestants, expectorants, antihistamines and antitussives, or cough suppressants.
The FDA "strongly recommends" that OTC cough and cold medicines not be used for infants and children younger than two, Dr Charles Ganley, director of the FDA's Office of Nonprescription Products, said on Thursday in a phone interview.
He said the FDA is concerned that parents hadn't gotten the message about the drugs despite heavy publicity on the issue in fall 2007.
The reality is these products are used quite a bit in this age group, and parents are using them without getting advice from a health-care provider," Ganley said.
Although the side effects are rare, they are serious, the FDA said. They can include death, convulsions, rapid heart rates, and decreased levels of consciousness.
Over the past two years, 1,500 babies and toddlers have wound up in emergency rooms after having a bad reaction to cold medicines, according to the U.S. Centers for Disease Control and Prevention. And in 2007, the FDA completed a review that found there were 54 reported child deaths from decongestants and 69 from antihistamines from 1969 and fall 2006. Most of those involved children under 2.
Health officials caution that the drugs' potential temporary benefits do not warrant the risk of those side effects.
"Remember that these medicines do not cure the cold. They do not shorten time you child has a cold, and they're only meant to help a child's symptoms," said Dr Lisa Mathis, the associate director for the FDA's Office of New Drugs, Pediatric and Maternal Health Staff.
The FDA's advisory comes about three months after some of the leading manufacturers of cold and cough medicines announced a voluntary recall of more than a dozen cold medicines for infants.
The Consumer Healthcare Products Association, the industry group representing makers of OTC drugs, said in October that the products were being pulled "out of an abundance of caution."
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