Concerns about the safety of epidural steroid injections skyrocketed recently in the United States due to a multistate fungal meningitis outbreak and numerous deaths among patients injected with contaminated solution from a single pharmacy in New England. Now comes news that persons treated with epidural steroid injections for back pain relief are at increased risk of spinal bone fractures, according to research funded by Henry Ford Health System in Detroit, Michigan.
In a presentation on October 25, 2012 at the annual meeting of the North American Spine Society, researchers described a retrospective study comparing data on 6,000 patients treated for back pain between 2007 and 2010; 3,000 patients received at least one lumbar epidural steroid injection and 3,000 did not receive injection [Mandel and Schilling 2012]. The average age of patients was 66 years and 64% were women.
Using survival analysis statistics, the researchers found that the number of epidural steroid injections patients received were linked to an increased likelihood of spinal bone fracture. With each injection, the risk of fracture increased by 29%.
“For a patient population already at risk for bone fractures, steroid injections carry a greater risk than previously thought and actually pose a hazard to the bone,” said Shlomo Mandel, MD — a Henry Ford orthopedic physician and the study’s lead author — in a press release [here]. He recommends that patients should be warned about the risks of potential fractures and have bone testing before receiving steroid injections.
COMMENTARY: This was a large-scale study, but it represents a retrospective, observational cross-section of patients; so, cause-effect relationships cannot be definitively concluded. Also, the findings were presented at a medical conference and should be considered preliminary until full data are available and undergo peer review prior to official journal publication.
ADDENDUM 6/15/2013 — This study has now been officially published in a peer-reviewed journal, see: Mandel S, Schilling J, Peterson E, et al. A Retrospective Analysis of Vertebral Body Fractures Following Epidural Steroid Injections. J Bone Joint Surg Am. 2013(Jun 05);95(11):961-964 [abstract].
According to the American College of Rheumatology, fractures of bones in the spine are common in patients with osteoporosis, affecting an estimated 750,000 people annually. Half of women and 1 in 6 men over 50 years of age will suffer a fracture related to osteoporosis. So, whether effects of epidural steroids cause the problem, accelerate osteoporosis, or are incidental still needs to be determined.
Mandel points out that other steroid treatments, such as those taken orally or by IV, have long been linked to bone loss. However, epidural steroid injections were thought to have little impact on bones since they are delivered directly to the problem area and believed to have less effect on the rest of the body. This may not be the case, he says, “If epidural steroids are causing fractures, it is probably because the treatment is not localized. The drug may be entering the circulatory system.”
We wrote about safety concerns regarding epidural steroid injections in an UPDATE last January [here], noting that nearly 9-million Americans received these interventional procedures during 2010 alone, and notices of serious adverse effects have prompted regulatory review of the procedures. At that time, an UPDATES reader recommended an excellent article in Practical Pain Management [here], advising that practitioners need to understand and educate their patients regarding the full scope of potential side effects that can occur with epidural steroids.
Regarding other pain conditions: In an UPDATE last April [here], we reported on research finding the either epidural or oral corticosteroids provide only modest and temporary pain relief of sciatica pain. Finally, an excellent article from the Journal of Prolotherapy [PDF here] features an evidence-based discussion of the deleterious effects of intraarticular corticosteroids on joint cartilage.
In a recent New York Times article [here], James P. Rathmell, MD, chief of pain medicine at Massachusetts General Hospital, noted that the U.S. Food and Drug Administration (FDA) is reviewing how to reduce the risk of “catastrophic neurological injuries” from epidural steroid injections. The risk of infection, such as the recent outbreak of meningitis, did not even factor into the review — though it will now, he added. Rathmell is a member of the review panel.
Corticosteroids are not currently FDA-approved for epidural injection. Yet, one focus of the FDA review will be on developing best practices for injection techniques with the aim of reducing risks of injury, according to the NY Times article.
Some practitioners contend the injections can be less risky than opioid analgesics or surgery. Even Rathmell concedes that, “In the right individuals, they are a tremendous help,” and complications occur in only about 1 in 10,000 cases.
Still, according to Laxmaiah Manchikanti, MD — who runs a pain clinic in Paducah, KY, and is chairman of the American Society of Interventional Pain Physicians — “We are doing too many of these, and many of those don’t meet the proper criteria.” He also said in the NY Times article that about 20% of practitioners who perform the procedures are not adequately trained.
While incidence rates of serious complications may be relatively low, increasing numbers of epidural injections may be taking a toll. Manchikanti said his own review of Medicare records found an increase of nearly 160% in the number of injections from 2000 to 2010. The increased use is driven by an aging population, the desperation of patients for pain relief, and the desire of practitioners to help — and there are financial incentives. Medicare and private insurers pay $100 to several hundred dollars for an injection, and there are pain clinics that do almost nothing but injections.
So, there is considerable discussion and evidence in the literature that steroid injections may do more harm than good in many cases, whether the intervention is for back or joint pain. While it seems evident that many patients with pain may be helped by these injections, the benefits may be short-term and potential risks should be considered.
REFERENCE: Mandel SS, Schilling JL. The Incidence of Subsequent Vertebral Body Fractures After Lumbar Epidural Steroid Injection. Paper #48 presented at North American Spine Society (NASS) annual meeting; October 25, 2012; Dallas, Texas.
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