People With Gout at Risk for Chronic Opioid Use

A new study from the Veterans Health Administration (VA) has found that people with gout were more likely to be prescribed opioids than those without gout, independent of other factors.¹

“Though used frequently to treat flare, risk of chronic opioid exposure in gout has not been well defined. In this study, we examined the hypothesis that people with gout are more likely than individuals without gout to be prescribed chronic opioids over time,” study investigator Lindsay N. Helget MD, Veterans Affairs Nebraska-Western Iowa Health Care System, and University of Nebraska Medical Center, Omaha, Nebraska, and colleagues wrote.¹

Helget and colleagues conducted a matched cohort study with VA data and used multivariable Cox regression to examine the association of gout with chronic opioid receipt (defined using a validated administrative algorithm). They identified gout using diagnostic codes and matched them with up to 10 non-gout controls by age, sex, and VA enrollment year. They also identified factors associated with chronic opioid exposure in analyses limited to gout.

Overall, the investigators found that over a mean follow-up of 4.52 years, gout patients (6.9%) were more likely to receive chronic opioids than controls (3.8%) even after adjusting for covariate factors (aHR, 1.30; 95% CI, 1.28-1.32). Among people with gout, Helget and colleagues found that more recent index year, younger age, female sex, non-Hispanic Black race/ethnicity, rural residence, being underweight or obese, former/current smoking, greater comorbidity, urate-lowering therapy receipt, and requirement of rheumatology consultation were factors that were independently associated with an increased likelihood of chronic opioid exposure.

The new findings are a follow-up to previously presented data by Helget and colleagues in 2023. The study, which included data from 16.7 million patients between January 1999 to January 2015, previously reported that 6.9% of gout patients had chronic opioid use (n = 28,948) compared with 3.8% of the non-gout patients (n = 137,497). At that time, after covariate adjustment, the HR was 1.36 (95% CI, 1.34 – 1.39) for gout patients to have chronic opioid use.²

The FDA has taken recent action to put a greater emphasis on the risks of opioid use and announced in July that it is requiring new labeling for opioids to emphasize long-term risks, including misuse, addiction, and overdose.³ The new changes come after a May 2025 public advisory committee meeting reviewed data showing demonstrating risks, including misuse, addiction, and both fatal and non-fatal overdoses, for patients who use opioids over long periods, from 2 large postmarketing requirement (PMR) observational studies, 3033-1 and 3033-2. The meeting also reviewed public comments, other medical research, and recognized the absence of adequate and well-controlled studies on long-term opioid effectiveness.⁴

The new labeling will require clearer risk information outlining data seen in long-term use studies, including overdoses and digestive health; dosing warnings; clarified use limits that emphasize the risks of long-term use; up-to-date treatment guidance; guidance on safe discontinuation; information on overdose reversal agents; and information on drug interactions. Sponsors have been notified of the required changes and have 30 days to submit their labeling updates to the FDA for review.³

“The death of almost 1 million Americans during the opioid epidemic has been one of the cardinal failures of the public health establishment,” Marty Makary, MD, MPH, FDA Commissioner, said in a statement.³ “This long-overdue labeling change is only part of what needs to be done — we also need to modernize our approval processes and post-market monitoring so that nothing like this ever happens again.”

References

1. Helget LN, England BR, Punyasha Roul, et al. Chronic Opioids in Gout: A Matched Cohort Study from the Veteran’s Health Administration. Arth Care & Res. Published online August 4, 2025. doi: 10.1002/acr.25622

2. ‌Derman C. Treating Gout Flares with Opioid Therapy Links to Chronic Opioid Use. November 20, 2023. https://www.hcplive.com/view/treating-gout-flares-with-opioid-therapy-links-to-chronic-opioid-use

3. Johnson V. FDA Emphasizes Opioid Risks in New Labeling Requirement. July 31, 2025. https://www.hcplive.com/view/fda-emphasizes-opioid-risks-in-new-labeling-requirement

4. UPDATED MEETING DATE AND PUBLIC PARTICIPATION INFORMATION: May 5, 2025 Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement. FDA. May 5, 2025. https://www.fda.gov/advisory-committees/advisory-committee-calendar/updated-meeting-date-and-public-participation-information-may-5-2025-joint-meeting-drug-safety-and