FDA: No OTC cough syrup for little ones

(CNN) -- When toddler Olivia Cavalli came down when the sniffles, her mother, Sarah, would quickly turn to the medicine cabinet.

Not anymore.

"I now just let it run its course," the 26-year-old mother from Drexel Hill, Pennsylvania, said. After learning of the potential side effects associated with over-the-counter cough syrup and cold medicines for toddlers and babies, Cavalli said, she decided the benefits of the drugs weren't worth the risk.

On Thursday, the government took what it called an important step in persuading others to make the same decision that Cavalli did in treating colds in young children.

The Food and Drug Administration issued a public advisory warning parents and caregivers against giving children under the age of 2 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 2, Dr. Charles Ganley, director of the FDA's Office of Nonprescription Products, said 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. Watch why the FDA is warning parents »

"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. Watch one family's tragic story »

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."

In advance of Thursday's FDA advisory, CHPA president Linda A. Suydam issued a statement in support:

"Last fall, the leading makers of OTC, oral cough and cold medicines for infants voluntarily withdrew these medicines out of concern that their potential misuse could lead to possible overdose among very young children. We took this voluntary action recognizing that infants are especially vulnerable to accidental misuse.

"Today's decision by FDA reaffirms the correct course of action taken by the leading makers of these medicines last fall," she said.

The FDA has been investigating the use of these drugs in children for some time. In October, FDA advisers voted 13-9 in favor of a statement that said cold medicines containing antihistamines, decongestants, antitussins and expectorants should not be used by children under 6.

Despite that non-binding vote, the FDA hasn't decided whether older children should use the drugs. Ganley said the FDA is expected to make a decision regarding the use of the drugs in children in the 2-11 age group this spring.

Baltimore, Maryland, Health Commissioner Dr. Joshua Sharfstein, who headed the push for the FDA hearings on the issue, said the FDA advisory was a "very important step," but said it didn't go far enough. "We think that these products should not be used under 6," he said.

On Thursday, Mathis offered advice to parents ahead of the FDA's decision regarding children older than 2 using over-the-counter cold medicines and cough syrup. She directed parents and caregivers to look at the active ingredient in the drugs, to take care in giving more than one kind of drug to children, to use only the measuring device that comes with the drug, and to consult a physician with questions.

For treating colds in infants and children under 2, the American Academy of Pediatrics recommends old-fashioned remedies, including plenty of fluids, rest, as well as saline drops and rubber nose bulbs to ease stuffy noses. If the child's condition doesn't improve, the group advises a trip to the pediatrician. E-mail to a friend

CNN's Jennifer Pifer, Elizabeth Cohen, Saundra Young and Ben Leach contributed to this report.

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