USA – FDA seeks input on genotyping for pediatric codeine use

The US Food and Drug Administration (FDA) is seeking public consultation on whether children under the age of 12 years should be permitted to receive analgesics containing codeine, if they have been cleared from having a genetic tendency to metabolize the drug at potentially toxic levels.

Currently, the use of products containing codeine is contraindicated in children under the age of 12. Codeine, an opioid indicated for relief of mild to moderate pain under some circumstances for adults, is partially metabolized to morphine through the liver’s CYP2D6 pathway. However, individuals vary greatly in their CYP2D6 metabolism of codeine. Those who are poor metabolizers may not receive sufficient analgesia, whereas so-called “ultra-rapid metabolizers” may experience opioid-related toxicity because of rapid elevation in serum morphine levels after administration of codeine.

The request for consultation was prompted by a citizen petition submitted by clinical pharmacologists and pharmacogeneticists who asked that the current contraindication to the use of codeine-containing products for those aged less than 12 years be amended to permit the use of these products in those known to be normal or intermediate CYP2D6 metabolizers…