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FDA Advises Against OTC Infant Cold Medicines
Agency issues Public Health Advisory, Warning That the Medicines are Dangerous



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If you’re treating a baby or child under age 2 with over-the-counter (OTC) cough and cold medicines – stop.
The U.S. Food and Drug Administration is now officially advising against the use of decongestants, expectorants, antihistamines and antitussives (or cough suppressants) to treat infants and children under age 2. In a just-released Public Health Advisory for parents and caregivers, the FDA warns that these medicines can cause serious, potentially life-threatening side effects in that age group.
“The FDA strongly recommends to parents and caregivers that OTC cough and cold medicines not be used for children younger than 2,” Charles Ganley, M.D., director of the FDA's Office of Nonprescription Products, said in issuing the advisory. “These medicines, which treat symptoms and not the underlying condition, have not been shown to be safe or effective in children under 2.”
The advisory comes after an FDA review of recommendations from two advisory committees which studied reports of rare, serious side effects from the use of cough and cold products in babies and children –  including convulsions, rapid heart rates, decreased levels of consciousness and death.
Review Continues for Kids Ages 2-11


The agency is still reviewing data on the medicines’ effects on children ages 2-11 and plans to make a final recommendation regarding that age group soon.
Until that decision is made, the agency recommends that parents and caregivers who give OTC cough and cold medicines to kids ages 2-11:


• Follow the dosing directions on the label,

• Understand that these drugs will not cure or shorten the duration of the common cold,

• Check the medication’s “Drug Facts” label to learn what active ingredients are in the products (many OTC cough and cold products contain multiple active ingredients), and

• Administer the medicine by using only measuring spoons or cups that come with it or are made specially for measuring drugs.
Many OTC Medicines for Infants Already Off the Shelves

In response to concerns about side effects, several leading manufacturers of OTC cough and cold medications starting pulling at least 14 types of infant oral medications from store shelves a couple of months ago, including infant decongestants or cough formulas by Dimetapp, Little Colds, Pediacare, Robitussin, Triaminic and Tylenol. 




An FDA safety review of nearly four decades of data had revealed dozens of deaths linked to accidental overdoses of the medications, most of them in children under age 2.

The problematic ingredients in these medications, according to pediatrician Ari Brown, M.D., are decongestants such as pseudophedrine or phenylephrine, antihistamines like carbinoxamine, and cough medications like dextromethorphan. Minor side effects associated with these medications include agitation or insomnia, while more severe side effects include hallucination, elevated blood pressure and heart rhythm abnormalities.

“These latter side effects, in some cases, can and have been fatal when children were accidentally overdosed,” says Brown, a spokesperson for the American Academy of Pediatrics (AAP).

“Here’s the rub,” Brown says, “the products are only marginally helpful in treating the symptoms of a common cold or flu. They do not treat the disease, and parents need to know that.”

What to Do for an Infant With a Cold

Rather than resorting to a dose of over-the-counter medication for your infant, Brown suggests using saline nose drops and a humidifier to loosen secretions in the nose, and providing lots of T.L.C. to keep your baby comfortable. She also has a reminder for parents: “The best cure for the common cold is time.”
Parents or caregivers with questions about caring for a baby or young child with a cold should contact their physician, pharmacist or other health care professional.

For more information and the full list of the FDA's recommendations, read the FDA's Public Health Advisory and Comsumer Update pages.

– Deirdre Wilson and Christina Elston

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