ROCKVILLE, Md., March 2 — The FDA is casting a weather eye on over-the-counter cough and cold remedies for children, looking into the possible risks of such nostrums for infants and toddlers.The agency is responding to a citizen’s petition filed by a panel of pediatricians and public health experts with the agency on March 1. The petitioners sent an advance copy to the New York Times, prompting the agency to hold a press briefing outlining its plans.
“We have been looking at this issue internally with regard to the safety and efficacy of cough/cold products in children,” said Charles Ganley, M.D., director of the office of non-prescription products at the Center for Drug Evaluation and Research.
“This really started early last year when there were some deaths reported in children in the central United States, in the same county, with the use of a product called carbinoxamine,” Dr. Ganely said. “After further review of this it was determined there were unapproved drug products on the market that contained carbinoxamine.”
Last June, the FDA ordered some 120 cough and cold medicines that contain carbinoxamine off store shelves. The two approved carbinoxamine-containing products can continue to be sold legally, the agency said.
The FDA said there is no evidence that carbinoxamine is safe for children under age two, yet dozens of cough drops and syrups marketed for infants and toddlers contained the compound. Twenty-one deaths have been reported among children under age two who took carbinoxamine products, the agency said.
In January of this year, the CDC announced that other prescription and over-the-counter cough and cold remedies had been linked to the deaths of three infants.
The infants, two boys and a girl from the ages of one to six months, were all found to have high levels of the nasal decongestant pseudoephedrine in their blood at autopsy, reported Arjun Srinivasan, M.D., and colleagues, in the Jan. 12 issue of Morbidity and Mortality Weekly Report.
Two of the children had detectable blood levels of the cough suppressant dextromethorphan and the analgesic acetaminophen (Tylenol), the investigators added.
The blood levels of pseudoephedrine in the children were nine to 14 times higher than those resulting from the recommended doses of the decongestant in children who are ages two to 12 years.
“Because of the risks for toxicity, absence of dosing recommendations, and limited published evidence of effectiveness of these medications in children ages younger than two years, parents and other caregivers should not administer cough and cold medications to children in this age group without first consulting a health-care provider and should follow the provider’s instructions precisely,” the investigators wrote.
The citizen’s petition, filed by 15 pediatric health experts, calls on the FDA to order a halt to marketing OTC cough and cold remedies for children under six, citing a lack of evidence of efficacy, and concerns about safety.
On the basis of its experience with carbinoxamine, the FDA had already decided to conduct an internal review to see if their were similar problems with other OTC products.
“It wasn’t just looking at adverse events in children less than two years of age, but also all children for which the products have been marketed legally for the last 30 years or so,” Dr. Ganley said.
He noted that the products, most of which have been on the market for decades, were typically evaluated for efficacy by extrapolating from adult data, and not with pharmacokinetic and pharmacodynamic studies in children.
“I think the important thing to note here is that are millions of doses of OTC cough/cold drug products that are used on a weekly basis by children very safely,” he said. “If the directions are to ask your doctor or consult a doctor prior to use in a specific age group, the parents need to adhere to that.”
Industry trade groups agreed with Dr. Ganley’s assertion.
“Millions of Americans safely and effectively use OTC cough and cold medicines every year — both for themselves and for their families,” said Linda A. Suydam, president of the Consumer Healthcare Products Association, in a statement. “These medicines have been found safe and effective by the FDA and are the same medicines that families have safely relied upon for decades to help relieve cough and cold symptoms and make their children feel better.”
But in guidelines issued last year, the American College of Chest Physicians strongly recommend against the use of OTC cough and cold medications in children 14 years-old and younger.
“Cough is very common in children. However, cough and cold medicines are not useful in children and can actually be harmful,” said guidelines chair Richard S. Irwin, M.D., of the University of Massachusetts Medical School in Worcester, Mass. “In most cases, a cough that is unrelated to chronic lung conditions, environmental influences, or other specific factors, will resolve on its own.”
No financial disclosure information was reported.