Co-Prescribing of Opioids and Gabapentinoids Grows Despite Warnings

By Pat Anson

In 2019, the FDA warned that serious breathing problems can occur in patients who take gabapentinoids with opioids or other medications that suppress the central nervous system. The agency said elderly patients and those with pre-existing lung problems were at highest risk of respiratory depression, which can lead to a fatal overdose.

Those warnings went unheeded by many doctors, according to a new study that found the co-prescribing of gabapentinoids to patients on long-term opioid therapy increased over the past decade, rising from 47% in 2015 to 58.7% in 2023.

Gabapentinoids are a class of nerve medication originally developed to prevent seizures, but are widely prescribed off-label to treat pain. They include gabapentin (Neurontin) and pregabalin (Lyrica), as well as generic versions of the drugs.

Not only did co-prescribing with gabapentinoids increase, but the age of patients on long-term opioids also rose, from 52.5 years in 2015 to 60.5 in 2023. Nearly half of those patients (48.7%) are on Medicare. 

“Because older adults are at higher risk of adverse events from polypharmacy, the increased rates of coprescribing, particularly with gabapentinoids, raises additional safety concerns,”  said Thuy Nguyen, PhD, Assistant Professor of Health Management and Policy at the University of Michigan’s School of Public Health.

Nguyen and her colleagues' findings, published in a JAMA research letter, also document a steady decline in long-term opioid use, which coincides with federal and state guidelines that were imposed to limit opioid prescriptions.  

Between 2015 and 2023, the number of U.S. patients on long-term opioid therapy for at least 90 days fell from 5.6 million to about 4.2 million — a 24.3% decrease. 

At the same time, the average daily dose of opioids also declined, from 47.9 morphine milligram equivalents (MME) in 2015 to 38.6 MME in 2023 – which is in line with CDC guidelines that recommend caution when doses exceed 50 MME.

Researchers think more work is needed to reduce opioid use and to find alternative ways to relieve pain.

“With almost 5 million Americans on long-term prescription opioids for chronic pain, and likely millions more who are taking shorter courses of prescription opioids for acute pain, most clinicians are likely to care for someone using prescription opioids for pain, highlighting the pressing importance for investing in better treatment models for pain,” said senior author Pooja Lagisetty, MD, Associate Professor of Internal Medicine at the University of Michigan Medical School.

In addition to gabapentinoids, researchers tracked overlapping prescriptions for other controlled substances. They found that co-prescribing of long-term opioids with benzodiazepines declined from 43.8% in 2015 to 33.5% in 2023; while co-prescribing for stimulants rose from 5.9% to 6.7%.

In short, polypharmacy is relatively common with patients on long-term opioids, despite the known risks of combining certain drugs. 

Common side effects from gabapentin include brain fog, dizziness, weight gain, headache, fatigue, and anxiety. The drug has also been linked to a higher risk of dementia.

Those side effects may lead to a “prescribing cascade,” in which doctors mistakenly prescribe unnecessary medications to patients that cause even more side effects – never suspecting that gabapentin was the cause and they should consider discontinuing the drug.

In 2024, gabapentin was the fifth most prescribed drug in the U.S., with prescriptions nearly tripling since 2010. The number of patients prescribed gabapentin reached 15.5 million in 2024.

The off-label prescribing of gabapentin is legal and, in some cases, appropriate. But it has reached extreme levels, with studies estimating gabapentin is prescribed off-label up to 95% of the time

Opioids, Off-Label Prescribing and the Road Not Taken

By Lynn Kivell Ashcraft, Guest Columnist

So much of the conversation about the use of opioids and other medications to treat various conditions has made it sound like doctors are doing something wrong when they utilize a treatment in an off-label fashion. 

Off-label prescribing is not a crime. The federal Agency for Healthcare Research and Quality (AHRQ) estimates that 1 in 5, or 20 percent, of all prescriptions are written for off-label use.

In fact, off-label use of a drug often represents the standard of care. The Food and Drug Administration never intended for its drug approval and labeling process to be the sole determining factor in how a drug is to be used in a clinical setting. 

It is left to physicians themselves to determine the ultimate clinical utility of pharmaceuticals, biologicals and medical devices in treating their patients.

Epidural Steroid Injections Are Off-Label

Some off-label use, however, is controversial. Many accepted protocols for treating back and neck pain include the use of epidural steroid injections (ESIs), despite a lack of rigorous supporting clinical evidence. As many as 9 million ESIs are performed in the U.S annually, yet few patients are told the injections are an off-label use of both the medication (corticosteroids) and the route of administration (an injection into the epidural space of the spine).

In 2014, after hearing about serious neurological problems in patients who received ESIs, the FDA required a label warning that injections of corticosteroids into the epidural space may result in rare but serious neurological events, including "loss of vision, stroke, paralysis, and death."  

Anxious not to lose a treatment that they believed in, professional societies of anesthesiologists, pain medicine physicians, rehabilitation specialists, neurosurgeons, surgeons, radiologists and interventional pain specialists wrote guidelines to prevent complications from ESIs that were published in the journal Anesthesiology in 2015. 

A coalition of doctors also formed the Multisociety Pain Workgroup (MPW) to defend the use of ESI’s. The MPW called an AHRQ study “flawed” and “absurd” because its questioned the effectiveness of ESI’s for treating low back pain. It also lobbied unsuccessfully to have the FDA tone down its warning.

Since 2017, according to OpenSecrets.org, the American Society of Interventional Pain Physicians has spent nearly $1.5 million on campaign donations and lobbying — much of defending the use if ESIs.

Where was the same type of outcry from the medical profession defending the use of opioid medication when the 2016 CDC guideline was released? Why have so many doctors stood by silently while insurers, states and the DEA began implementing the guideline as policy?

Lynn Kivell Ashcraft is an analytic software consultant and writer who lives in Arizona. Lynn has lived with chronic intractable pain for almost 30 years and works with Dr. Forest Tennant as part of the Arachnoiditis Research and Education Project.