Pediatricians Demand Recall of Children’s Cold Medicines

By Susan Brinkmann, OCDS
Staff Writer
As a new cold season looms, pediatricians are urging the Food and Drug Administration (FDA) to demand a recall of over-the-counter (OTC) cold medicines for children younger than six years old because of the potential for life threatening side affects.

“Parents should know that there is less evidence than ever to support the use of over-the-counter cough and cold medicines for young children,” said Dr. Joshua Sharfstein, Baltimore’s health commissioner, in a report by OneNewsNow. “There is nothing that is holding the FDA back from asking for a voluntary recall now of products marketed to kids under six.”

Doctors say OTC medications such as decongestants, expectorants, antihistamines and cough suppressants only mask the symptoms and can’t cure the cold so why take the risk? Bed rest and plenty of fluids are still the best way to get rid of a cold.

Commonly used cough and cold medicines send about 7,000 children to hospital emergency rooms each year with symptoms ranging from hives and drowsiness to unsteady walking. While low doses of these medicines rarely cause problems, unintentional overdoses and even the mixing of a cough suppressant with a decongestant can cause serious side affects in some children.

In January of this year, the FDA issued a warning against giving OTC cold medicines to children younger than two. At that time, officials said they expected to decide by the spring on recommendations for youngsters up to 11. The agency is now seeking more advice from doctors, industry and consumers.

Manufacturers of OTC products say these medications have been used for decades in treating kids’ colds and are safe for those older than two. However, FDA standards for the use of cough and cold medicines date back 30 years with no separate studies having been done for children.

Manufacturers voluntarily stopped selling cough and cold medicines for babies and toddlers last fall and are now carrying out new studies to determine how safe these products are for children. 

The Consumer Healthcare Products Association, which represents the manufacturers, says preventable errors are the problem, not the safety of the ingredients in the medicines. The industry is starting an educational campaign aimed at parents, doctors and day care providers on the importance of following directions and storing medicines in places where kids cannot get at them.

But Sharfstein said Maryland saw an immediate benefit after OTC cough and cold remedies for tots were removed from store shelves last fall. Calls to poison control about problems with the medicines involving children younger than two dropped by 40 percent, from 99 to 60, in the first six months of this year when compared with 2007. Calls involving children two to six also dropped, but by much less.

Pending completion of their ongoing review, the FDA is urging parents and caregivers who give OTC cough and cold medicines to children ages 2 to 11 to:

1) Follow the dosing directions on the label of any OTC medication,

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

3) 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

4) Only use measuring spoons or cups that come with the medicine or those made specially for measuring drugs.

For more information, visit the “Questions and Answers for Consumers” page on the FDA website at

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