I order to keep us all safe, the FDA is constantly monitoring drugs and their side effects. For many years codeine was prescribed for children for pain relief as well as to suppress coughs. Over the last few years there has been more and more discussion about limiting the use of narcotics in children, but I continue to see some children who come from seeing other physicians and have received a prescription that contains codeine.
The FDA just issued new warnings against using prescription codeine in children and adolescents. The FDA reviewed adverse event reports from the past 50 years and found reports of severe breathing problems and 24 deaths linked to codeine in children and adolescents. Genetic variation in codeine metabolism may lead to excessive morphine levels in some children.
The FDA also performed a literature review which noted excessive sleepiness and breathing problems, including one death, in breast-fed infants whose mothers used codeine.
Due to these findings the FDA is now recommending that “codeine should not be used for pain or cough in children under 12 years of age”. They have also issued a warning that codeine should not be used in adolescents aged 12-18 “who are obese or have conditions associated with breathing problems, such as obstructive sleep apnea or severe lung disease”. In retrospect, codeine was prescribed to more than 800,000 children younger than11 years in 2011. Amazingly, codeine is currently available in over-the-counter cough medicines in 28 states.
Lastly, the FDA “strengthened the warning” regarding codeine and breast feeding. They now recommend that breast- feeding women do not use codeine…which may change the post delivery pain protocol. Nonsteroidal anti-inflammatories (Ibuprofen) and acetaminophen (Tylenol) are preferred and are effective for mild to moderate postpartum pain. As a pediatrician it is important that I discuss this with new breast-feeding mothers as well.