FDA just released this announcement of the required labeling changes for long-acting opiates, such as Oxycontin, a form of extended-release oxycodone. FDA states: “The updated indication further clarifies that, because of the risks of addiction, abuse, and misuse, even at recommended doses, and because of the greater risks of overdose and death, these drugs should be reserved for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain; ER/LA opioid analgesics are not indicated for as-needed pain relief.”
FDA also indicated that it is requiring further post-marketing studies of long-acting opiates. They cite “The goals of these postmarket requirements are to further assess the known serious risks of misuse, abuse, increased sensitivity to pain (hyperalgesia), addiction, overdose, and death.” What is interesting to me is mention of hyperalgesia, a phenomenon whereby pain worsens with the use of an opiate, only to get worse with subsequent dose increases. The incidence of this phenomenon is not known and may be a significant source of pain in older adults. However, I am generally not concerned with appropriate use of long-acting opiates in older adults because many of the alternatives are far worse, such as NSAIDs and their well-established serious adverse effects in the older adult population.