CHICAGO – In response to serious new questions about remedies parents have relied on for decades, the Food and Drug Administration said Friday it would study the safety and effectiveness of over-the-counter cold medicines marketed for young children.

The agency’s move came in reaction to a petition by leading pediatricians and public health officials who on Thursday urged the FDA to restrict companies from marketing certain cold and cough medicines to children age 6 and younger, citing reports of deaths, heart arrhythmias and other dangerous events.

The agency said the review was called for, in part, because over-the-counter cough and cold medicines have only been studied in adults with those findings on safety and efficacy “extrapolated” to children.

The government’s decision to study the efficacy of cough and cold medicines on children is certain to set off concerns among many parents. The FDA advised consumers in the interim to abide by the labels and consult with their own doctors about treatments.

The FDA’s move is the latest, and perhaps most serious, expression of concern about over-the-counter cough and cold medicines. But skepticism has been building over the last decade, with some physicians wondering whether they should even be given to children at all. Some doctors question whether such medicines are all that effective in the first place.

“I just don’t recommend cough medicines for kids because I do not think they work very well,” said Dr. Elizabeth Powell, an emergency medicine physician at Children’s Memorial Hospital who has published data on injury prevention. “I know a lot of families are trying to get some relief so their kids can sleep but I think, because they are potentially toxic, and we really don’t think they work. Do they want to risk harm?”

Powell’s hospital routinely does not recommend over-the-counter cold or cough medicines because studies show they are not effective, Julie Pesch, a hospital spokeswoman said.

Doctors, including the American Academy of Pediatrics, have been concerned about the risks of cold and cough medicines for at least the last decade. In 1997, for example, the Academy warned about the risks of overdose potential and other risks with certain cough suppressants.

And last month, the U.S. Centers for Disease Control and Prevention published a study of hospital emergency departments that found more than 1,500 children under age 2 were treated for “adverse events, including overdoses, associated with cough and cold medications.” The report identified three deaths.

The CDC study cited cough and cold medicines that contain nasal decongestants, antihistamines and cough suppressants, among other remedies. Such products are taken in the “millions” of dosages each week by children, but pediatricians also questioned the effectiveness of such medicines including those outlined in the CDC report.

“This is one of those things where the evidence accumulates to the point where then finally the general community of physicians and scientists says this needs another look,” said Dr. Wayne Snodgrass, who chairs the American Academy of Pediatrics committee on drugs and signed the petition as part of his role as professor of pediatrics and pharmacology at University of Texas Medical Branch in Galveston. “It’s like a lot of things. It would have been nice to have done this earlier.”

The FDA is expected to complete its review in the next several months, Dr. Charles Ganley, director of the agency’s office of nonprescription drug products, told reporters on a conference call Friday afternoon.

“This is something that we have been looking at from the middle of last year,” Ganley said. “If there are issues that need to be addressed, we would address them.”


The FDA said it would look at the safety and effectiveness of decongestants, antihistamines, cough suppressants and expectorants on children 6 and under.

“We have always followed the lead of the FDA for carrying new products or removing existing ones,” said Michael Polzin, a spokesman for pharmacy giant Walgreen Co. “We do not anticipate any action in the near term. As the FDA reportedly said, it is too early to predict whether a review would lead to new regulations.”

The Consumer Healthcare Products Association, which represents the over-the-counter drug industry, said cough and cold remedies have a long history of safety “when used according to the label,” the group’s president, Linda Suydam, said.

“Current FDA assessment of the safety and efficacy of approved children’s over-the-counter antitussives, expectorants, nasal decongestants, antihistamines, and combination cough cold products is based on scientific studies in children and/or on extrapolation from extensive data in adults,” she added. “This process of extrapolation follows internationally recognized recommendations for diseases which are similar in adult and pediatric patients and applies to the symptoms and conditions for these medicines.”

Earlier this year, the American College of Chest Physicians said over-the-counter cough suppressants don’t work, casting doubt on the billions spent every year to fight the common cold’s most irritating symptom. Its statement applied only to medications that claim to treat coughs, not other cold symptoms, and it suggested cold sufferers ignore over-the-counter drugs with the active ingredients dextromethorphan and the expectorant guaifenesin.

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AP-NY-03-02-07 2059EST