FDA Acknowledges Harm of Rapid Opioid Tapering
FDA Acknowledges Harm of Rapid Opioid TaperingApril 10th, 2019 by
The FDA Admits Problems with Rapid Opioid Tapering and Discontinuation
In an advisory issued yesterday, the FDA acknowledged the harm caused by sudden discontinuation of opioids and rapid tapering. The agency stated that they have received reports that included “serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide”. They also acknowledge that these adverse effects also lead many pain patients to turn to use of illicit opioids such as heroin to manage their pain and withdrawal symptoms.
The FDA is Taking Action
In response to these reported problems, the FDA is requiring changes to the prescribing information for opioids related to opioid tapering or discontinuation. Guidance for health care professionals now will include:
Health care professionals should not abruptly discontinue opioids in a patient who is physically dependent. When you and your patient have agreed to taper the dose of opioid analgesic, consider a variety of factors, including the dose of the drug, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient. No standard opioid tapering schedule exists that is suitable for all patients. Create a patient-specific plan to gradually taper the dose of the opioid and ensure ongoing monitoring and support, as needed, to avoid serious withdrawal symptoms, worsening of the patient’s pain, or psychological distress.
There are no standard opioid tapering schedules that are suitable for all patients. A patient-specific plan should be used to taper the dose of the opioid gradually.
In general, for patients who are physically dependent on opioids, taper by an increment of no more than 10 percent to 25 percent every 2 to 4 weeks. It may be necessary to provide the patient with lower dosage strengths to accomplish a successful taper.
If the patient is experiencing increased pain or serious withdrawal symptoms, it may be necessary to pause the taper for a period of time, raise the opioid analgesic to the previous dose, and then once stable, proceed with a more gradual taper.
The FDA further advises that a multimodal approach to pain management should be used, but only specifically mentions psychological support, where indicated.
The FDA also suggests the following to pain patients: “Contact your health care professional if you experience increased pain, withdrawal symptoms, changes in your mood, or thoughts of suicide. Also contact them if you have any questions or concerns”.
It’s Progress, But Not Enough
If these new FDA guidelines on opioid tapering are widely adopted, they should result in a reduction in the amount of suffering experienced by opioid-dependent pain patients. Many prescribers abruptly discontinued or abruptly tapered patients due to fear of prosecution. The new FDA labels will provide not only guidance but also some protection from prosecution for physicians who take a more measured approach.
Pain patients who have already been abruptly discontinued or rapidly tapered and are still suffering may want to bring this FDA announcement to the attention of their prescribing physicians. Hopefully, this will result in appropriate corrective action on the part of the physician. PLEASE NOTE THAT IF YOU HAVE GONE THROUGH OPIOID WITHDRAWAL, IMMEDIATELY GOING BACK TO A HIGH PREVIOUS DOSE CAN BE DEADLY BECAUSE YOUR BODY HAS ADAPTED TO THE ABSENCE OF THE OPIOIDS.
This is a very welcome correction by the FDA to what has been a horrendous situation for many patients who are in severe chronic pain. However, I believe that the FDA should have included more information in their guidance to both patients and professionals about other pain treatments, especially alternative pain treatments. This would help pain patients more effectively manage their pain with or without opioid tapering.
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This article has guidance on how to deal with abrupt opioid withdrawal:
Please see the following articles for information on alternative pain treatment:
Explore all our articles on alternative pain treatments HERE