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Risk of serious spinal adverse events associated with epidural corticosteroid injections in the Medicare population
  1. Efe Eworuke1,
  2. Leah Crisafi2,
  3. Jiemin Liao3,
  4. Sandia Akhtar3,
  5. Martha Van Clief1,
  6. Judith A Racoosin1,
  7. Michael Wernecke3,
  8. Thomas E MaCurdy3,
  9. Jeffrey A Kelman4 and
  10. David J Graham1
  1. 1Division of Epidemiology, US Food and Drug Administration, Silver Spring, Maryland, USA
  2. 2Department of Perioperative Medicine, Clinical Center, National Institutes of Health, Bethesda, Maryland, USA
  3. 3Acumen LLC, Burlingame, California, USA
  4. 4Centers for Medicare and Medicaid Services Washington DC Office, Washington, District of Columbia, USA
  1. Correspondence to Dr Efe Eworuke, Division of Epidemiology, US Food and Drug Administration, Silver Spring, MD 20993, USA; efe.eworuke{at}fda.hhs.gov

Abstract

Background Epidural corticosteroid injections (ESIs) are widely performed and have an unquantified risk of serious spinal adverse events (SSAEs). We sought to determine the rate of SSAEs following ESI and to compare the rates by spinal level, injection approach and corticosteroid formulation.

Methods We included patients enrolled in Medicare parts A and B who had an ESI between 1 January 2009 and 30 September 2015. We identified potential cases as patients with spine-related diagnoses within 3 days after the first eligible ESI. Event categorization as probable, possible or non-case was based on review of medical records. The rates of probable and possible cases were expressed per 1 000 000 patients overall, and by spinal level, injection approach and corticosteroid formulation. A score test was used to compare these rates.

Results We identified 1 355 957 eligible ESIs during the study period. Of the 110 potential cases, 43 were selected for medical record review and 11 were categorized as probable, yielding a rate of 8.1 per 1 000 000 patients (95% CI 4.5 to 14.5). Risk of SSAEs was statistically higher with cervical/thoracic injections (29.4, 95% CI 12.5 to 68.8) compared with lumbar/sacral injections (5.1, 95% CI 2.3 to 11.0) (p value 0.001). Event rates for lumbar/sacral non-transforaminal injections was 8.8 (95% CI 4.0 to 19.1). Event rates for particulate (7.5, 95% CI 3.9 to 14.2) and non-particulate formulations (13.1, 95% CI 3.6 to 47.9) appeared similar (p value 0.47).

Conclusion Between 2009 and 2015, rates of SSAEs following ESI in the Medicare population were low. Patients receiving cervical/thoracic ESIs were at higher risk of SSAE than those receiving lumbar/sacral ESIs. Event rates were similar for each corticosteroid formulation.

  • drug-related side effects and adverse reactions
  • epidemiology
  • injections
  • spinal
  • pain management
  • regional anesthesia
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Footnotes

  • Contributors All authors contributed to the conception of the study design, interpretation of data, revision of the manuscript critically for important intellectual content and gave the final approval of the version published.

  • Funding This study was funded by the US. Food and Drug Administration (FDA) through an Inter-agency agreement with the Centers for Medicare & Medicaid Services.

  • Disclaimer The views expressed in this publication are those of the authors and do not necessarily reflect the official policy of the Food and Drug Administration, the Centers for Medicare & Medicaid Services, or the Department of Health and Human Services.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data may be obtained from a third party and are not publicly available. The data used for this study are not publicly available.

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