FDA Cautions Against Abruptly Stopping Patients’ Opioids

The Food and Drug Administration (FDA) has recently received reports of serious harm, including uncontrolled pain, withdrawal symptoms, and suicide, among patients who faced abrupt discontinuation or rapid dose reductions of their opioid analgesic medications.

In response, the FDA last month issued a drug safety announcement to expand guidance on safe tapering and announced new prescribing information requirements for all opioid pain medications used in outpatient settings. The changes provide physicians with more information on how to safely decrease the dose for patients who are physically dependent on these medications.

“The new guidelines make a lot of sense because abrupt discontinuation of opioids leaves patients with profound chemical disturbances on top of their undertreated pain, which can lead to new addictions, anxiety, or depression,” said Elie G. Aoun, M.D., a general, addiction, and forensic psychiatrist and forensic psychiatry research fellow at Columbia University; and vice chair of APA’s Council on Addiction Psychiatry.

In a statement from the FDA, Douglas Throckmorton, M.D., the deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, confirmed these risks: “[E]veryone who is treated with opioids for any length of time develops a physical dependence—meaning there will be withdrawal symptoms if the treatment suddenly stops.” In turn, these symptoms can drive patients to seek other sources of opioids, including heroin, he added.

AMA President Barbara L. McAneny, M.D., welcomed the new FDA guidance, given that “overdoses and deaths continue to plague communities around the nation.” She emphasized the right approach for tapering depends on conversations between patients and physicians, including the decision to maintain patients on the current dose if the benefits outweigh the risks. “This patient-centric approach will encourage discussions between patients and physicians on whether a decrease in dose or discontinuation of the opioid is the best approach,” she said.

Aoun agreed. “Tapering has to be done in a rational, evidence-based way, with an understanding of why the high dose was being prescribed in the first place and is respectful of the patient’s experience. An alternative treatment plan must be in place and started early to replace the opioid pain medications.”

Using an evidence-based opioid-tapering approach “can avoid severe side effects and minimize risks,” wrote Throckmorton. “Critically important, any taper must be tailored to the individual patient’s clinical and personal situation,” he added. Factors to consider when tapering include the dose of the opioid medication, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient.

In “Pocket Guide: Tapering Opioids for Chronic Pain,” the Centers for Disease Control and Prevention (CDC) advises physicians to consider tapering or halting treatment when the patient does not have clinically meaningful improvement in pain, when the patient is on 50 morphine milligram equivalents or more per day without benefit, when opioids are combined with benzodiazepines, or when patients experience overdose or another serious adverse event.

When the patient and physician agree to a dose reduction, the CDC recommends a 10% decrease of the original dose per week as a reasonable starting point, noting that patients who have taken opioids for a long time may need slower tapers, such as 10% per month.

The CDC guide also instructs physicians to “make sure patients receive appropriate psychosocial support. If needed, work with mental health providers, arrange for treatment of opioid use disorder, and offer naloxone for overdose prevention.”

Aoun said the new FDA guidelines and CDC pamphlet on tapering reflect ways of “trying to find a balance with the way we are prescribing opioids. We’ve gone from one extreme to the other: from overtreating pain in the ’80s and ’90s and all the negative consequences that entails, including addiction and new onset of criminal justice problems, to the recent restriction of access to opioids that may prevent people from getting pain management who need it. The new guidelines will hopefully bring the pendulum back to somewhere in the middle.”

While physicians bear a responsibility for their prescribing practices, Aoun said that many other factors in the health care system have played a role in the overprescribing of opioids, including government guidelines, hospital reimbursement policies based on patient satisfaction ratings, and insurance company pressures on physicians to limit patient visits and time spent with patients.

“Ten minutes is not a sufficient timeframe to educate patients on pain, nonopioid medication alternatives, and nonpharmacological treatment options, such as psychotherapy to improve their own pain tolerance or acupuncture,” Aoun said.

The AMA wrote that it continues to advocate against the misapplication of CDC guidelines in ways that prevent or limit patients’ medical access to opioid analgesia by pharmacists, health insurers, pharmacy benefit managers, legislatures, and governmental and private regulatory bodies.

As part of the drug safety alert, the FDA also updated information on other side effects of opioid use, including central sleep apnea and drug interaction, and on proper storage and disposal of these medications. ■