FDA Review of the use of Codeine for Kids

FDA Review of the use of Codeine for Kids

The European Medicines Agency (EMA) bold statement regarding the use of codeine in children has a struck a cord with the U.S. Food and Drug Administration (FDA).  The EMA states that codeine should not be used for children under the age 12. Codeine is an opioid analgesic used to treat pain that can also be found in children’s cold and cough medicine. Codeine is metabolized by the body and turns into morphine. It is a central nervous system depressant that can have dangerous side effects that include; slowed breathing, drowsiness, nausea, vomiting, sedation, addiction, bradycardia, syncope, hallucinations, seizures, anaphylaxis, and even death.

Eric Pahon with the FDA in response to EMA’s codeine declaration, “We have looked at their data and feel it is well-presented and seems firm. We are not really recommending anything at the moment. The FDA will continue to evaluate this safety issue and will consider the EMA recommendations”. In the FDA’s defense, they did issue a warning to physicians in 2013 that advised not to prescribe codeine for children after a tonsillectomy/adenoidectomy due to a higher risk of breathing complications. But was this warning heard? Was it sufficient?

Since 1999, the FDA reports that 10 children have died and 3 have overdosed on Codeine. The American Academy of Pediatrics is against giving codeine in a cough suppressant. In 2007, the FDA did however talk many pharmaceutical companies into taking over-the-counter (OTC) cold and cough drugs off the market for infants. We can’t stop physicians from prescribing these medications to our patients, but we can make sure we thoroughly educate the parents of these children on the dangers of Codeine. We can also educate parents on specific signs and symptoms to look for that may indicate a problem, such as, labored or loud breathing, confusion, and fatigue.