Advisory committees to the U.S. Food and Drug Administration are recommending that prescription drugs with codeine should not be given to children and teens for the treatment of cough or pain. They are also pushing for the restriction of over-the-counter (OTC) sales of cough syrups containing codeine, according to Medpage Today.
The FDA panel, composed of the agency's Pulmonary-Allergy Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, held a meeting Thursday to discuss the safety of codeine in kids 18 years old and younger.
The joint meeting analyzed the risk of codeine's serious side effects on children. The committee members reported that some children develop respiratory problems after taking codeine, and in several cases they stop breathing and die. In the last decade, at least two dozen cases of deaths caused by breathing problems associated with codeine have been recorded, NPR reported.
"My concern, were I to be prescribing codeine in children, would be that I would, frankly, kill them," said Maria Pruchnicki, pharmacist at the Ohio State University College of Pharmacy.
Codeine is used to treat pain and relieve cough associated with allergies. It is a prescription medicine, although OTC products for cold, allergy, cough, antiashthmatic drugs and bronchodilator also contain codeine.
Experts from the National Center for Health Research and the American Academy of Pediatrics recommended that the FDA follow the example of Europe, Canada and Australia, which have already implemented regulations restricting codeine.
"The use of codeine or any other opioid cannot be recommended for the treatment of cough in children," Dr. Constance Houck, AAP representative and anesthesiologist at Boston Children's Hospital, said at the meeting.
