Welcome back to the Clinical Corner. In this issue, we will touch on new FDA requirements, focused on the labeling for opioid products.
It is common knowledge that the opioid crisis and epidemic continues to be a major health concern in the United States. In an effort to stop or limit the potential of opioid misuse, some patients have been forced to taper off, or worse yet, abruptly stop opioids when they have been on them chronically. This change can cause patients to use opioids illicitly, or even generate suicidal tendencies brought on by withdrawal symptoms or the feeling of having no control of their condition.
This guidance will not require prescribers to taper opioids, but rather give some direction on how to taper the products in eligible patients. Some potential candidates may be patients where opioid risks outweigh the benefits, such as those taking high-doses or where side effects are present.
Tapering schedules are dependent on the amount and length of time a patient has been on an opioid therapy. For patients with chronic pain, it may be difficult to completely taper off opioids. In these patients, it may be more common for them to end up on a lower dose that controls their pain and offers less potential for adverse effects. It is important for patients to remember that the goal of opioid therapy is not complete pain relief, but rather improving pain and function. As patients may experience withdrawal symptoms during the tapering, providers will again need to decide which patients are appropriate for a tapering trial. If during the taper, the patient experiences withdrawal symptoms, the provider may choose to taper slower or consider supplemental treatment to help alleviate the symptoms.
Hopefully, the new requirement by the FDA will be a new tool to help eliminate the potential for overuse or misuse of opioid medications. While tapering may not be appropriate in all patients, there are some who may be able to reduce or eliminate the use of opioids and try non-pharmacologic options for the treatment of pain or other conditions.
Thanks for stopping by and see you next month at Ron’s Clinical Corner.