FDA agrees to 2nd look at cough medicines

In a move sought by Baltimore health officials, federal regulators said yesterday that independent experts will hold hearings to evaluate safety concerns about cough and cold remedies for young children.

The announcement comes months after the city health commissioner and other experts petitioned the Food and Drug Administration to prohibit drugmakers from marketing the remedies for infants and to require warning labels stating the products "have not been found to be safe or effective" for children under 6.


Dr. Joshua M. Sharfstein, the health commissioner, said the FDA's decision to conduct two days of advisory panel hearings in October shows the agency is "taking the issue seriously."

Meanwhile, the FDA reiterated yesterday previous warnings that parents not give cough or cold remedies to children under the age of 2 without first consulting a physician.


Similar warnings have been issued by the medication manufacturers and by the U.S. Centers for Disease Control and Prevention.

The CDC also advises doctors to "exercise caution" before recommending the drugs for children that young and to always ask the parents about other medicines the child might be receiving.

"There is little evidence that cough and cold medicines work in children under 2 years of age," the CDC says, adding that the drugs "can, in rare cases, be harmful or even fatal."

When the petition was filed in March, Dr. Charles Ganley, director of the FDA's Office of Nonprescription Products, urged parents to follow directions on the products.

Dr. Robert Ancona, chief of pediatrics at St. Joseph Medical Center in Towson, said the FDA advisory on consulting a physician was "a very reasonable thing" because the medicines have never been proved to work in very young children and sometimes cause harm. While most of the products give the same advice on their labels, a few do not, he said.

In a statement posted on its Web site, the Consumer Healthcare Products Association, a drug industry group, also emphasized that labels of all cough and cold medicines direct parents and caregivers to contact physicans before giving the medications to children under 2.

Follow directions

Drug industry representatives contend that cold and cough medications are clearly labeled with instructions concerning use in children and that adverse reactions are most likely the result of directions not being followed.


But Sharfstein said current warnings are not enough.

The group's petition asks the FDA to go a step beyond previous label warnings by restricting the marketing of them for use in children under 6.

Sharfstein said the fact that the FDA is going to hold hearings is more important than reiterating warnings: "I think what the FDA is saying is a step on the way to re-evaluating what currently exists. But if this remains the FDA's position, it would be disappointing."

In their petition, Sharfstein and other physicians cited the deaths of four Baltimore children under age 4 in the past six years linked to cough and cold medications.

The culprit in the deaths appeared to be a cough suppressant, dextromethorphan, an ingredient in many of the preparations, said Ancona, who was not involved in the petition. The parents apparently overdosed their children when the youngsters didn't respond to a more appropriate dose, he said.

In a follow-up letter to the FDA in May, the physicians said the absence of dosing information on labels for children under 2 constitutes a "safety hazard in an age range highly vulnerable to overdose."


Because labeling instructions direct parents to consult doctors before giving the medicine to children under 2, it creates an impression that medical evidence exists for appropriate dosing levels for them. "But no such evidence exists," the letter said.

Factor in deaths

The letter also cited a study that found the medications either caused or were contributing factors in the deaths of 13 children under age 16 months in Philadelphia between 1999 and 2005.

Ganley, the FDA official, promised that the review of the petition would include an assessment of the safety and efficacy of cold and cough medications for children, as well as how dosage levels for them are drawn up.

Cold medications for children have been criticized in the past.

Last year, the American College of Chest Physicians released clinical practice guidelines advising caregivers not to recommend cough suppressants and other over-the-counter medications for young children because of their ineffectiveness and the increased risk of complications and death.


If you go

The FDA meetings are scheduled Oct. 18 and 19, from 8 a.m. to 5 p.m., at the National Labor College, Lane Kirkland Center, Solidarity Hall, 10000 New Hampshire Ave., Silver Spring.

Background material will be posted by Oct. 16 at Submit written comments by Aug. 28 at:

To make a presentation, contact the FDA at 301 827-7001 or To attend, call a few days ahead to confirm meeting dates and times: 1-800-741-8138.

Sun reporter Stephanie Desmon contributed to this article.