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Last updated on April 19, 2014 at 18:42 EDT

FDA Issues Warning For Use Of OTC Cold Remedies In Children Under 2

January 18, 2008

The FDA issued a warning today that over-the-counter cough and cold medicines are too risky for children under the age of 2.  The warning states that “serious and potentially life-threatening side effects can occur.”

The FDA is still reviewing whether or not over the counter decongestants, antihistamines and cough suppressants are safe for older children, agency officials told Associated Press.   A decision is expected by this spring, the deadline to notify manufacturers before production for next year’s cold season begins.

Last October, drug companies quit selling many versions of over the counter cold medicines targeted at babies and toddlers after a vote of FDA advisers affirmed the drugs don’t work in children under 6.  

Dr. Charles Ganley, the FDA’s chief of non-prescription drugs, worries that parents may still have these drugs at home, or that they may buy drugs meant for older children and instead give them to infants, according to an Associated Press article.   “We still have a concern,” Ganley told AP.  “It falls out of people’s consciousness.  We’re still in the middle of cold season right now.”

Dr. Joshua Sharfstein, Health Commissioner for the city of Baltimore, led a petition last year to end the use of OTC cold remedies in children under 6.  The petition, backed by the American Academy of Pediatrics, was started because there is no evidence these OTC drugs ease cold symptoms in children so young, and therefore the benefits outweighed the risks of side effects.  Today’s move is a good first step, Dr. Sharfstein told Associated Press.  

Data from the Centers for Disease Control and Prevention support Dr. Sharfstein’s position, and show that over 1,500 babies and toddlers visited emergency rooms during a two-year period because of OTC cold remedies.

“It’s one thing if you’re curing cancer, but we’re talking about a self-limiting illness,” said Sharfstein.   

Medical specialists now recommend fluids, rest, saline drops and humidifiers to treat cold symptoms in children under 2.  

For their part, the drug industry says OTC cold remedies are used almost 3.8 billion times a year in treating cold symptoms in children under 2, and that the drugs are safe.  

However, health groups concede that there is a risk to children in cases of unintentional overdose.   This can occur in cases where the same ingredients are used in multiple products that the child may ingest.  Accidental overdose can also occur when medicines are measured with kitchen teaspoons instead of the dropper or measuring cap that comes with the product.

Following this warning, the FDA is now reviewing whether OTC cold medicines are safe and effective for any children under the age of 12.  An internal FDA working group is reviewing whether to recommend the agency take any action for children ages 2-11.  The deadline for the recommendation is next month.

Pending completion of this review, the FDA recommends the following guidelines to parents and caregivers that choose to use OTC cough and cold medicines in children ages 2 to 11:

- Follow the dosing directions on the label of any 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.    

The FDAs warning can be viewed at http://www.fda.gov/bbs/topics/NEWS/2008/NEW01778.html