The Food and Drug Administration states it will take a closer look at cough and cold medicines for children that contain codeine.
“We are evaluating all available information and will also consult with external experts by convening an advisory committee to discuss these safety issues,” says an announcement posted Wednesday on the FDA website.
The move comes after European Medicines Agency said in April that such medications “must not be used to treat cough and cold in children under 12 years.” They also recommend not giving the medicines to children between 12 and 18 years of age. The concern is that It may cause side effects including “slowed or difficulty breathing.”
In 2013 the FDA added its strongest warning against prescribing codeine after surgery to remove tonsils in children. In Wednesday’s announcement, the FDA said, “Parents and caregivers who notice signs of slow or shallow breathing, difficult or noisy breathing, confusion, or unusual sleepiness in their child should stop giving their child codeine and seek medical attention immediately by taking their child to the emergency room or calling 911.”
The American Academy of Pediatrics have been against prescribing codeine to children since 1997.
Unlike adults, there are some children who don’t metabolize the drug and need a higher dose, while other metabolize it too quickly, which may lead to an overdose. Dr. Alan Woolf, director of the Pediatrics Environment Health Centre at Boston Children’s Hospital, points out, “Codeine is notorious for rashes, hives, vomiting in kids and constipation.”
According to a study, doctors don’t seem to be heeding that warning, and there are still 870, 000 prescriptions of codeine written every year for children of all ages. Children between 8 to 12 years old are most likely to receive a codeine prescription.
“I hope doctors and patients are going to be extra careful in prescribing or asking for this kind of medicine,” Shu said of the FDA safety announcement.