In 2013 the FDA recommended against the use of codeine in pain medication, or as an antitussive in children less than 12 years of age. In 2015 and 2017 it strengthened its warnings; leading to a contraindication and label changes on codeine containing medications. Click here to view the recommendation.

At that time, they added warnings to the use of codeine in children less than 18. This was done because of the increased risk of side effects including difficulty breathing and death in children who had received codeine. A recent citizen’s petition is asking the FDA to remove these warnings and recommend that children get genetic testing to see if codeine is safe to use in them. The SPPM is strongly opposed to this move and along with leaders for the Society for Pediatric Anesthesia and other leading experts wrote a strong letter in opposition of relaxing these restrictions. Genetic testing is not widely available, it is not reliable, and it is often not covered by insurance companies. Relaxing these restrictions is not the answer to improved access to pain medications at this time. Without easily available, reliable and affordable testing, increased use of codeine will lead to increased complications and even death in children.