One of the most trusted pain prescriptions for older adults has been linked to a sharply higher risk of heart failure—raising troubling questions about the safety of everyday treatments we thought we understood.
Quick Take
- A major Medicare study finds pregabalin increases heart failure risk by nearly 50% in older adults with chronic pain.
- The risk is even higher—up to 85%—for those with pre-existing cardiovascular disease.
- Gabapentin, a similar medication, showed a significantly lower risk in direct comparison.
- No difference in all-cause mortality, but results prompt urgent reevaluation of prescribing practices.
Medicare Data Shakes Up Pain Management Assumptions
Between 2015 and 2018, over 246,000 Medicare beneficiaries aged 65 to 89 began taking pregabalin or gabapentin for chronic, noncancer pain. When outcomes were analyzed, the numbers stunned even seasoned physicians: those starting pregabalin faced a 48% higher risk of developing new-onset heart failure than those starting gabapentin. For patients with a history of heart disease, the risk surged to 85%. The findings, published in August 2025 in JAMA Network Open, quickly reverberated through clinics and advisory panels nationwide.
This is not just a story about numbers; it’s about the cascade of decisions that shape the lives of millions of older Americans. Chronic pain affects nearly one in three seniors. As opioid dangers became glaringly apparent, gabapentinoids—specifically pregabalin and gabapentin—rose as preferred alternatives. But this new heart failure signal suggests even our “safer” options may carry hidden costs.
How Did Pregabalin Become a Go-To Pain Solution?
Pregabalin (brand name Lyrica) and its cousin gabapentin (Neurontin) began life as seizure drugs, but their fortune changed as they were repurposed for nerve and musculoskeletal pain. As opioid prescriptions plummeted, use of these gabapentinoids soared—especially among seniors desperate for relief. The FDA has approved pregabalin since 2004, and it’s been widely regarded as safe, with only scattered reports of swelling and heart issues. Until now, large-scale studies had not directly compared its risks to gabapentin, leaving a gaping hole in the evidence used to guide treatment.
Physicians, facing a deluge of chronic pain complaints and wary of opioid pitfalls, often saw pregabalin as a low-risk answer. The new study’s real-world data—adjusted for an impressive 231 variables—smashed through old assumptions. The heart failure rates were not just statistical quirks: they translated into real people facing hospitalizations, new medications, and, for some, a sobering loss of independence.
Who Is Most at Risk—and What Happens Next?
Not all patients face the same danger. The risk spike was most dramatic among those who already had cardiovascular disease—a group that makes up a large proportion of older pain patients. For them, the numbers force an uncomfortable reckoning. Providers are now urged to take a hard look at patient history, weighing the immediate need for pain control against the longer-term threat of heart complications.
Expert voices have joined the chorus of caution. Dr. Rick Pumill, a cardiologist, notes, “This new data reinforces what many of us have observed in practice—that older adults, particularly those with cardiovascular disease, require careful evaluation and monitoring when this medication is considered.” The medical world is now grappling with a central tension: how to balance compassion for suffering against the duty to protect patients from avoidable harm.
Guidelines, Industry, and the Future of Pain Treatment
Regulatory agencies, including the FDA, are watching closely. While no label changes have been mandated yet, calls for further research and updated guidelines grow louder. The pharmaceutical industry, especially pregabalin’s manufacturer Pfizer, faces mounting pressure to respond transparently. Clinical societies are likely to revisit recommendations, and physicians may turn more often to gabapentin or non-pharmacologic options for patients with heart risk factors.
For patients and families, the conversation shifts. What was once a routine prescription now demands a dialogue about trade-offs. The good news: the study found no increased risk of death from any cause with pregabalin versus gabapentin. But the specter of heart failure—a chronic, life-altering condition—is enough to give anyone pause. As research continues, one message cuts through the noise: in medicine, “safe” is always a moving target, and yesterday’s answers are never final.
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