By Pat Anson, PNN Editor

Tapering patients to lower doses of opioid pain medication significantly raises the risk of opioid withdrawal, drug overdose and a mental health crisis such as depression, anxiety or suicide attempt, according to a large new study. For most patients, the risk remains elevated up to two years after their doses were reduced.

Opioid prescribing has fallen dramatically in the United States over the past decade, particularly after the release of the CDC’s controversial opioid guideline in 2016. Although millions of patients were affected, few efforts were made to study patient outcomes or what happens to those who have their opioid doses reduced or even stopped.

To address this knowledge gap, researchers at the University of California Davis School of Medicine analyzed health data for over 19,300 patients on long-term opioid therapy who had their doses reduced by at least 15 percent. In addition to medical and pharmacy claims, researchers looked at emergency room visits and hospital admissions for overdose, withdrawal or mental health crisis, both before and after tapering.

"We used an innovative observational study design to understand the patients' experience before and after opioid dose reduction. We compared outcome rates in pre- and post-taper periods with patients serving as their own controls," said co-author Daniel Tancredi, PhD, a pediatrics professor at UC Davis Health.

"While patients may struggle during the early tapering period, we reasoned that many may stabilize with longer-term follow-up and have lower rates of overdose and mental health crisis once a lower opioid dose is achieved," said lead author Joshua Fenton, MD, professor and vice chair of research at UC Davis School of Medicine.

But Fenton and his colleagues found patients continued to struggle long after their doses were cut. Their findings, published in JAMA Network Open, show a 57% increase in overdose or withdrawal incidents and a 52% increase in mental health crises 12 to 24 months after doses were lowered.

For every 100 patients during pre-tapering, there was an average of 3.5 overdose or withdrawal events and 3 mental health crises. After tapering, there were 5.4 overdose/withdrawal events and 4.4 mental health crises for every 100 patients. The risks associated with tapering were greatest in patients with the highest doses.

"Our findings suggest that, for most tapering patients, elevated risks of overdose and mental health crisis persist for up to two years after taper initiation," said Fenton. "We hope this work will inform a more cautious approach to decisions around opioid dose tapering."

An earlier study at UC Davis found that tapered patients were 68% more likely to be treated at a hospital for opioid withdrawal, overdose or alcohol intoxication, and were twice as likely to have a mental health crisis.

‘I Was Cut Off Cold Turkey’

The FDA warned in 2019 that rapid tapering or abrupt discontinuation was causing serious harm to patients. The CDC Director also pledged that year to evaluate the impact of the agency’s opioid guideline on patients and to “clarify its recommendations.”

Three years later, not a word of the CDC guideline has changed and the agency is slow walking efforts to revise it. A revised guideline draft, which cautions doctors to avoid rapid tapering or discontinuation, is not expected to be finalized until late this year. In the meantime, many doctors continue to taper patients – even those who’ve taken opioids safely and responsibly for years.

“Yesterday, I was cut off of one of my opioid medications, cold turkey. I've been given one last 30-day supply of the other, after 19 years of chronic pain treatment with opioid medication. I am bedridden,” a patient told us in a recent PNN survey on the impact of the 2016 guideline.

“Currently my pain management doctor is tapering everyone from schedule II (opioid) medications, even with years of good results and no side effects. This is dangerous when people are dealing with real pain,” said another patient.

“Before the guidelines, my pain was controlled with fentanyl patches and Vicodin for breakthrough pain. I was able to work, care for my home and family. That's all been taken away and now I spend my time either in bed or on my couch, in pain. Tapering down was 7 months of hell in my bedroom. It was cruel and unnecessary to take away medicine that allowed me to enjoy and participate in my life,” another patient wrote.

In an editorial also published in JAMA Network Open, two University of Alabama at Birmingham researchers who are studying the role of tapering in patient suicides urged doctors to be more cautious.

“Our view is that opioid dose reduction is likely to offer benefit for some, while harming others. The harms may include worsening pain, distress, or death,” wrote Stefan Kertesz, MD, and Allyson Varley, PhD. “Given this uncertain balance of harm and benefit, it would be wise for health systems to stop promoting this change to care. A policy of tapering all patients to doses lower than a specified threshold cannot be supported from available evidence.”

Kertesz and Varley are currently recruiting family and friends of patients who died by suicide to participate in a pilot study about the impact of opioid tapering on their loved ones. To participate in their study, click here to take an online survey or call 1-866-283-7223.