In 2012, the FDA required a warning and additional contraindication in labeling for any products that contained codeine. This was designed to discourage doctors from prescribing the medications for post-surgery pain relief in children who’d just had a tonsillectomy or adenoidectomy.
The FDA made the changes after receiving reports of deaths in children who had received codeine medication after either of those procedures. The FDA says the deaths appear to be related to using the drug in children whose cytochrome P-450 CYP2D6 genotype causes a faster conversion of codeine into its metabolite, morphine.
While the overall use of codeine containing products isn’t necessarily high overall, it appears high in those patients. Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines say only 1 to 2% of patients have this genotype, which puts them at a higher risk for morphine toxicity, should they be treated with codeine. The CPIC says about 5 to 10% of the population has a genotype that’s associated with poor conversion of codeine to morphine, meaning those patients wouldn’t get any pain relief from the drug. The CPIC also says this genotyping typically is not done before codeine is given to a patient.
As such, many children’s hospitals have completely removed codeine from their formularies. Instead of using products that contain codeine, hospitals are using more acetaminophen, ibuprofen, oxycodone, and oxycodone-acetaminophen combination products.
While the cost of genotype testing would not necessarily be prohibitive, it is not practical for patients who have a one-time short-term need for pain relief, as labs say the testing turnaround time can be anywhere from a few days to a few weeks.
Genotype testing may be beneficial, however, in the case of patients who have something like sickle cell disease, who may need codeine on a recurring basis.
A report from the May issue of Pediatrics showed a “large number of children” who visited emergency rooms were given codeine to treat cough and upper respiratory infections, even though it went against the American Academy of Pediatrics and the American College of Chest Physicians recommendations.
According to the report, hospital emergency rooms prescribed codeine to children 558,805–876,729 times annually, every year between 2001 and 2010, before the FDA issued the warnings.
Much of the prescribing can likely be attributed to the idea that codeine offers pain relief greater than over-the-counter drugs, but not as strong as what opioids. However, there is not much benefit to using codeine, particularly in children.
The report stated that the removal of codeine from hospital formularies is a potential strategy to decrease the inappropriate use of the drug in children.
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