By Charles Bankhead, Staff Writer, MedPage Today

Published: August 16, 2007

Reviewed by Zalman S. Agus, MD; Emeritus Professor at the University of Pennsylvania School of Medicine

ROCKVILLE, Md., Aug. 16 -- The FDA warned parents not to give nonprescription cough and cold medicines to children younger than two years.

The warning came in a Public Health Advisory stating that "questions have been raised about the safety of these products and whether the benefits justify any potential risks from the use of these products in children, especially in children under two years of age."

In addition to the warning, the agency announced an Oct. 18 advisory panel meeting to discuss the possible need for more prohibitions or warnings related to the OTC products. The FDA has begun a review of safety and efficacy data for specific ingredients contained in the medications and will present findings at the meeting.

Aside from warning parents not to give the medications to children younger than two, the FDA offered the following advice:

Consult a clinician regarding any uncertainty about the use or safety of nonprescription cough and cold medicines.
Do not give children adult-strength medicine.
Read and follow all directions that accompany the medicine.
Be aware of risks associated with giving young children too much medicine.
Use medication measuring devices (such as a dropper or dosing cup) to ensure accurate dosing.
Stop using the product and consult a clinician immediately if a child's condition worsens or does not improve.

The FDA action represents the continuation of a response begun in March when a group of pediatricians and public health authorities petitioned the agency to halt marketing of OTC cough and cold remedies for children younger than six. The 15 physicians and scientists who drafted the petition cited a lack of efficacy for the products and concerns about safety. (See FDA Puts Kids' Cough Remedies Under the Microscope).

In June 2006 the FDA ordered removal of 120 carbinoxamine-containing cough and cold medicines from store shelves. According to the agency, the action was taken because of a lack of evidence that carbinoxamine is safe for children younger than two.

In January of this year, the CDC announced that three other ingredients common to prescription and OTC cough and cold remedies had been linked to three infant deaths. All three of the infants had elevated blood levels of pseudoephedrine and two had detectable levels of the cough suppressant dextromethorphan and the analgesic acetaminophen.

Wayne R. Snodgrass, M.D., Ph.D., of the University of Texas Medical Branch at Galveston, who chairs the American Academy of Pediatrics' committee on drugs, said widespread use of the nonprescription medications has persisted despite lack of evidence that the products are effective or safe for young children.

"This is not some life-threatening illness that we're talking about," said Dr. Snodgrass, a coauthor of the petition. "We have to keep in mind that we're talking about the common cold."

Concern about the safety and efficacy of OTC cough and cold remedies is nothing new, commented Jan Drutz, M.D., of Baylor College of Medicine in Houston. The FDA action on the issue is.

"We've known for a long time now that a lot of antihistamine-decongestant cough suppressant medication has not been advised to be given to children," said Dr. Drutz. "I think this is the first the FDA has really come out and said 'We don't condone this usage.'"

Courtesy of MedPage Today