Parents with sniffling and congested tots under the age of two should not give them over-the-counter cough and cold medication, the U.S. Food and Drug Administration has declared.
In a long awaited Public Health Advisory issued Thursday, the FDA said the use of non-prescription cold medication is too risky for tots and could cause "serious and potentially life-threatening side effects."
The advisory applies to all infant formula decongestants, expectorants, antihistamines, and cough suppressants. The agency says the products "have not been shown to be safe or effective in children under two" and can be dangerous.
"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 agency said in a statement.
The warning has been expected for months. Last October, drug companies in the U.S. and Canada , including such products as Dimetapp Oral Infant Cold Drops and Benylin for Infants Cough and Cold Drops.
Later the same month, the Nonprescription Drugs Advisory Committee met to discuss the safety of cough and cold drug product use in children. to the FDA that cold medications should not be given to children under the age of six because the drugs simply aren't effective on children so young.
At the time, Health Canada said it would review the panel's proceedings.
"Health Canada will consider the results of this meeting as we move forward with our review and recommendations regarding these products," the agency said in a statement last October.
For now, Health Canada recommends parents refrain from using cold remedies in children under the age of two "unless instructed to do so by a healthcare practitioner."
No decision yet on meds for older kids
The FDA still hasn't decided if the meds are safe for children aged two to 11-year-olds.
Dr. Charles Ganley, FDA's nonprescription drugs chief, told The Asscociated Press that an internal FDA working group has a February deadline to determine whether any action should be taken, with an announcement likely to be made in the spring.
Pending completion of that review, the FDA advises parents and caregivers who choose to give cough and cold medicines to children ages 2 to 11 years to:
- follow the dosing directions on the label of any over-the-counter (OTC) medication,
- understand that these drugs will NOT cure or shorten the duration of the common cold,
- check the "Drug Facts" label to learn what active ingredients are in the products because many OTC cough and cold products contain multiple active ingredients, and
- only use measuring spoons or cups that come with the medicine or those made specially for measuring drugs.
- not use these products to sedate or make children sleepy.
The FDA issued a public health advisory last August recommending parents use patience rather than non-prescription drugs. Despite the publicity, the U.S. regulatory body has been concerned parents aren't getting the message.
Recent studies have shown little evidence to support these oral drugs actually ease cold symptoms in young children. While serious side effects are rare, they do occur.
In December, an editorial published in the New England Journal of Medicine said at least 123 deaths in children under the age of six have been connected to over-the-counter drugs.
The U.S. Centers for Disease Control and Prevention reported in 2007 that more than 1,500 children under the age of two were rushed to emergency rooms over a two-year period because of cold-medication use.
Doctors recommend parents use old-fashioned remedies such as plenty of rest and fluids, saline drops to loosen a stuff nose and humidifiers to help children sleep through the night.
