Gabapentin Does Not Increase Risk of Falls in Older Adults with Fibromyalgia

Alexander Chaitoff, MD, MPH

Credit: University of Michigan

Incident use of gabapentin was not associated with increased fall-related visits in older adults with diabetic neuropathy, postherpetic neuralgia, or fibromyalgia.¹

These findings, from an active comparator study, were published in a recent paper by lead investigator Alexander Chaitoff, MD, MPH, Department of Internal Medicine, University of Michigan School of Medicine, and Center for Healthcare Delivery Sciences, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, and colleagues.

Painful conditions significantly increase the risk of falls in older adults and the medications used to treat these conditions may also increase the risk of falls. Recently, gabapentin, one of the most common medications used to treat painful conditions, had its prescriptions drop by 20% in 2022 from 2020 after several studies highlighted potential safety concerns. However, fall risks stemming from the conditions themselves may be inaccurately attributed to gabapentin use, and lead to undertreatment of pain.¹

Chaitoff and colleagues conducted a comparator study with the primary outcome of hazard of experiencing any fall-related visit in the 6 months after initiating gabapentin or duloxetine until discontinuation of treatment. The trial’s secondary outcomes included hazard of severe fall-related events defined as a fall associated with hip fracture or emergency department visit or hospitalization associated with a fall. Investigators adjusted for baseline characteristics by using stabilized inverse probability of treatment weighting.

The analytic cohort included 57,086 older adults with a diagnosis of diabetic neuropathy, postherpetic neuralgia, or fibromyalgia initiating treatment with gabapentin (n = 52,152) or duloxetine (n = 4934). Participants had an overall median follow-up duration of 30 days (IQR, 30-90).¹

The investigators found that the weighted cumulative incidence of a fall-related visit per 1000 person-years was 103.60 at 30 days, 90.44 at 90 days, and 84.44 at 180 days for gabapentin users. For duloxetine users, incidence was 203.43 at 30 days, 177.73 at 90- days, and 158.21 at 180 days. Accordingly, incident gabapentin users had a lower risk of falls at 6-month follow-up (hazard ratio, 0.52 [95% CI, 0.43-0.64]) but no difference in the hazards of experiencing severe falls. These findings were supported by sensitivity and subgroup analyses.¹

The investigators stated that patients with pain often report feeling undertreated, making accurate risk/benefit estimates for pain medications especially important. Their findings should inform conversations between physicians and patients who are considering starting gabapentin.¹

In other exciting news about fibromyalgia, the FDA recently accepted Tonix Pharmaceuticals’ New Drug Application (NDA) for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) to treat fibromyalgia, which could become the first new drug for treating fibromyalgia in 15 years.²

“The FDA’s acceptance of our NDA represents another step forward as we pursue our goal of delivering the first member of a new class of medicines for the management of fibromyalgia, a condition affecting over 10 million adults in the US,” said Seth Lederman, MD, Chief Executive Officer of Tonix Pharmaceuticals, in a statement.² “The fibromyalgia community, comprised of patients and their families and support groups, has been waiting for a new drug for over 15 years.”

REFERENCES

1. Chaitoff A, Desai RJ, Choudhry NK, Jungo KT, Haff N, Lauffenburger JC. Assessing the Risk for Falls in Older Adults After Initiating Gabapentin Versus Duloxetine. Ann. Intern. Med. Published online January 6, 2025. Doi: 10.7326/ANNALS-24-00636

2. Tonix Pharmaceuticals Announces FDA Acceptance of the New Drug Application (NDA) for TNX-102 SL for Fibromyalgia. Globe Newswire. December 17, 2024. https://www.globenewswire.com/news-release/2024/12/17/2998199/28908/en/Tonix-Pharmaceuticals-Announces-FDA-Acceptance-of-the-New-Drug-Application-NDA-for-TNX-102-SL-for-Fibromyalgia.html. Accessed December 17, 2024.