FDA Reviewing Cold Drug Safety in Kids

Special Focus on Safety in Infants Less Than 2 Years Old

From the WebMD Archives

March 2, 2007 -- The FDA today announced it is reviewing the safety and effectiveness of over-the-counter cough and cold medicines for children.

The review follows a CDC report of three babies who died in 2005 after taking cough or cold medications.

The FDA's drug review began last year and will take several more months to complete, says Charles Ganley, MD, director of the Office of Nonprescription Products at the FDA's Center for Drug Evaluation and Research.

Meanwhile, the FDA says parents should strictly follow dosing instructions on children's cough and cold medications and not give children adult formulations.

Ganley stressed that point in a news conference.

"There are millions of doses of OTC cough, cold drug products that are used on a weekly basis by children very safely," Ganley said.

"Parents need to strictly adhere to the dosing directions," he said.

"If dosing directions are to ask your doctor or consult a doctor prior to use in a specific age group, parents need to adhere to that. That allows the physician to make a determination of whether the drug product is appropriate in that age group," Ganley said.

Particular Concern for Babies

Ganley said there are "issues related to the safety of those products" in children under 2 years old.

He said the FDA worked with the CDC on a January 2007 report that noted the three U.S. infants (all 6 months or younger) who died in 2005 after receiving cough and cold medications.

All three babies had what appeared to be high levels of a nasal decongestant in their bloodstream.

In addition, 1,519 children 2 years old and under were taken to U.S. emergency departments during 2004-2005 for side effects associated with cough and cold medications, including overdoses.

FDA Responds to Petition

Ganley said the FDA got a reporter's call on Wednesday about a petition that had not yet been submitted to the FDA.

The petition alleges that the effectiveness of cough and cold medications hasn't been established in children aged 2-6 years, Ganley said.

WebMD asked the FDA for the petition. An FDA spokeswoman refused, saying they had just gotten the petition and didn't have a copy to share.


Ganley said the drugs' effectiveness in children was extrapolated from adult efficacy studies and had been reviewed by an expert panel.

But the drugs haven't been studied in children.

"It's incredibly difficult to be able to establish efficacy with these types of studies in children," Ganley said.

"If you're going to require that they have to have a study in children that statistically shows a significant difference between the active drug and a placebo, then you're essentially going to have no products available to treat respiratory symptoms in children," he said.

"It's a much more complicated issue than saying the therapeutic dose is not correct and it's leading to all these adverse events," Ganley said.

"In some situations, this issue is related to what's administered and how much is administered, and it may not be following the instructions on the label," he said.

Trade Group Responds

The Consumer Healthcare Products Association (CHPA) issued a statement about the safety and effectiveness of over-the-counter (OTC) cough and cold medicines.

In the statement, the CHPA notes that millions of Americans use OTC cough and cold products every year.

The CHPA also stresses the importance of following label instructions. "It is worth noting that the labels of all cough and cold medicines for children direct parents and caregivers to contact a physician before giving to a child under 2 (at a minimum)."

"The makers of all medicines welcome the opportunity to continue working with the FDA to ensure consumers have access to the safe and effective medicines they rely on," it states.

WebMD Health News Reviewed by Louise Chang, MD on March 02, 2007


SOURCES: Charles Ganley, MD, director, Office of Nonprescription Drug Products, FDA. WebMD Medical News: "Cold Medicine Risky for Kids Under 2." Susan Cruzan, FDA spokeswoman. News release, Consumer Healthcare Products Association.

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