At NASS 2012, Shlomo Mandel, Henry Ford West Bloomfield Hospital, Bloomfield Hills, USA, stated that epidural steroidal injections are associated with an increased risk of vertebral fractures.
Mandel told delegates that a prospective observational study by Al-Shoha et al (Spine 2012; epub), of which Mandel was a co-author, showed that a single epidural steroid injection in postmenopausal women was associated with a significant decline in hip bone mineral density (BMD) six months after the injection compared with baseline levels. He added that the study he was presenting investigated the potential association between epidural steroidal injections and the risk of vertebral fractures.
In the retrospective cohort, patients who had received at least one lumbar epidural steroid injection were compared with a match control group (3,000 vs. 3,000 from a cohort of 50,000 patients diagnosed with back pain). Patients were followed for five years or until the documented end of their medical history from the time of their first injection or time of their initial diagnosis of back pain. The outcome measure, of the number of vertebral body fractures in each group, was assessed through a word search of the radiological database (eg, “fracture”, “endplate deformity” and other fracture-related terms). Mandel reported that the incidences of vertebral fractures for each group were assessed according to survival analyses.
According to Mandel, the number of injections was associated with an increasing likelihood of vertebral fractures. Furthermore, each subsequent injection increased the risk of fracture by 1.21 times (p=0.03) adjusting for covariates. Mandel said: “Based on results of these two studies [the one on loss of BMD as well as the one on increased risk of vertebral fractures], we look more carefully at BMD, we order BMD assessment if it has not been previously recorded and, more importantly, we spend more time talking to our patients about the risk of reduced BMD and the possibility of complications. When I think there is higher likelihood of a fracture because of risk factors, I try to find non-steroidal based alternatives to treatment.”
He added that he was “well aware” of the “gravity” of what the findings indicate but said: “We stand by our results. We welcome more investigations. For our part, with what I call phase III (“Using bisphosphonate medications to prophylactically reduce the post epidural spinal injections bone loss and vertebral bone fractures”), we are looking at whether we can reduce the rate of bone loss and fractures in people who have had epidural steroidal injections.”
In the USA, a potentially contaminated batch of epidural steroid injections has been associated with an outbreak of fungal meningitis. The death toll, at the time of press, was 29 with 356 cases of fungal meningitis reported overall. The FDA recently confirmed it has issued “FDA form 483” to the New England Compounding Center, which produced the batch of steroids associated with the outbreak. The form indicates that FDA inspectors believe that conditions or practices at the centre may have violated the Federal Food, Drug or Cosmetic Act or related regulations. However, the form is not a final FDA determination that the Act has been violated. The incidence has raised questions about the overall safety of epidural steroid injections.
