FDA examines safety of using codeine in children's drugs
According to reports, FDA is increasing the level of its examination of safety concerns related to the use of cough syrups having codeine, for children below the age of 12. According to an announcement posted on the regulatory agency's website on Wednesday, experts are evaluating the available information and will also seek advice from external experts.
Earlier also, the FDA has raised concerns regarding the use of codeine products in children. The agency also issued a warning in 2013, in which it spoke against the prescription of the drug following surgery for removal of tonsils in children.
In the announcement made on Wednesday, the agency urged parents, or the primary caregiver to keep an eye on adverse reactions to codeine.
According to the announcement, "Parents and caregivers who notice any 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".
Still, some doctors do not pay attention to the warning. According to a study, there were 870,000 prescriptions for codeine cough syrup every year for children of all ages. It was found that children aged eight to twelve were most likely to get a prescription.
Some children are not able to metabolize the drug containing codeine and require higher doses and others metabolize it quickly, so it is a problem in both the cases that could cause inadvertent overdoses and other problems.