The U.S. Food and Drug Administration (FDA) is warning that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death. The injections are given to treat neck and back pain, and radiating pain in the arms and legs. They are requiring the addition of a Warning to the drug labels of injectable corticosteroids to describe these risks. Patients should discuss the benefits and risks of epidural corticosteroid injections with their health care professionals, along with the benefits and risks associated with other possible treatments.

As part of FDA’s ongoing effort to investigate this issue, they plan to convene an Advisory Committee meeting of external experts in late 2014 to discuss the benefits and risks of epidural corticosteroid injections and to determine if further FDA actions are needed.

There are specific prohibitions in the label related to adverse events that are reported and documented. The preservatives required to preserve shelf life are neurotoxic to spinal nerves and when the material is injected intrathecally it causes a host of unintended and catastrophic consequences that are documented but largely under reported by physicians. Steroids solution are only approved for intra joint, intradermal or intralesion applications. This is true for Metilprednisolone, Triamcinolone and Betamethasone. When bacteria are introduced during the injection process the steroid actually act as a culture media for growth and delay the host immune response allowing a toehold for growth. Further, the conditions of compounding cannot produce materials with a solubility index that reduces the particulate materials to a size that can be tolerated for absorption into the CSF in the case of accidental injection intrathecally due to the granule size is too large for absorption.

http://www.hcplive.com/product-news/FDA-Warns-of-Neurological-Risks-Linked-to-Epidural-Corticosteroid-Injections

Epidural corticosteroid injection into the epidural space has rocketed in the recent years. An increasing number of adverse events has been described and, probably, they are underreported. There are many ways of dirailment: the route of injection (transforaminal…), the technique itself, the fungal viral or bacterial contamination of the injectate, the air bubles, the issue of the particulate steroids, the final target….All interventional and non interventional approaches have their risks that every day interventional pain physicians are dealing with.

The FDA Advisory Committee will have a daunting work to do.

It is not always clear in the literature whether the adverse effects / complications are due to the drug or i.e. the epidural technique. In experienced hands or in a training situation. Epidural blocks with widely used local anesthetics also produce neurological deficits (i.e. abducens paresis). Care has to be taken in blaming a corticosteroied as the only cause..

My patient who is responsible for injecting epidural steroids JTHartman orthopedic surgeon that worked with Alon Winnie and they published the first international paper

In Anesthesia Analgesia in 1973.dr H has been with me since 1993 as patient

In 20 years we have done 3 lumbar -caudal lysis of adhesions to L4-5 in 1993,1998 and the last time in 2002 also a L2-3 transforaminal catheter lysis for spinal stenosis

In addition for cervical radiculopathy 8 years ago left sided C 5 cervical lysis of adhesions

Couple of years ago had shoulder replacement left side

12 years ago for right shoulder pain supra scapular nerve pulsed RF

4 months ago Right C5 site specific local steroid injection

2 months ago Right C5 lysis of adhesions with 3 reinjection hypertonic series

At no time have we done single epidural steroid injections

He is an informed patient

He has been member of the American Board of Orthopedic Surgery, Professor and Chairman of Orthopedics and the Dean of my Medical School TTUHSC

He has given me permission to write about his medical events

In addition I have been expert witness in over 350 cases , many of them related to ESI's

They work and better than not doing them especially in acute cases

They are not comparable to site specific injections

Doctors use them with minimal training and understanding and cheapest possible way

Because of reimbursement issues for equipment and medications and NO training requirement for physicians we have disasters

Compounding pharmacies are not all bad

No blind legislation will stop problems- just look at the prescription related narcotic induced deaths

Please note our discs disintegrate and bone on bone is not necesserily

I fully agree with Dr GR. Before we conclude against epidural steroid issue, we should also consider the numbers of patients who are extreemly benifited by epidural steroid treatment.

This review emphasizes the high risk of spinal infarction, paralysis, and death involved with cervical and thoracic transforaminal steroid injections but a smaller risk with lumbar transforaminal epidural injections. However, these risks have not been proven to be true with cervical or thoracic interlaminar epidural injections with no reports for lumbar and caudal epidural injections. Thus, extrapolating the evidence from cervical and thoracic transforaminal epidurals, or even lumbar transforaminal epidurals, is inappropriate to use for all corticosteroid injections and different types of epidural injections. These techniques are vastly different. Consequently, the risks are also vastly different, thus providing warning to the public and physicians without providing pertinent evidence and based on limited input, is considered inappropriate for an agency such as the FDA.

http://www.painphysicianjournal.com/2014/july/2014;17;E451-E474.pdf

Letter to FDA Anesthetic and Analgesic Drug Products Advisory Committee Meeting on Epidural Corticosteroid Injections for Pain.

https://www.asra.com/news/9/letter-to-fda-anesthetic-and-analgesic-drug-products-advisory-committee-meeting

Very interesting article on this topic.

The proper Role for Epidural Injection of corticosteroids

James P Rathmell

Unfortunately, the common sense is uncommon everywhere.

ANESTHESIOLOGY 2015

Background: Epidural corticosteroid injections are a common treatment for radicular pain caused by intervertebral disc herniations, spinal stenosis, and other disorders. Although rare, catastrophic neurologic injuries, including stroke and spinal cord injury, have occurred with these injections.

Methods: A collaboration was undertaken between the U.S. Food and Drug Administration Safe Use Initiative, an expert multidisciplinary working group, and 13 specialty stakeholder societies. The goal of this collaboration was to review the existing evidence regarding neurologic complications associated with epidural corticosteroid injections and produce consensus procedural clinical considerations aimed at enhancing the safety of these injections. U.S. Food and Drug Administration Safe Use Initiative representatives helped convene and facilitate meetings without actively participating in the deliberations or decision-making process.

Results: Seventeen clinical considerations aimed at improving safety were produced by the stakeholder societies. Specific clinical considerations for performing transforaminal and interlaminar injections, including the use of nonparticulate steroid, anatomic considerations, and use of radiographic guidance are given along with the existing scientific evidence for each clinical consideration.

Conclusion: Adherence to specific recommended practices when performing epidural corticosteroid injections should lead to a reduction in the incidence of neurologic injuries.

Steroids in transforaminal epidural injections are widely used to ease radicular pain in both cervical and lumbar radiculopathy. Concerns have been articulated about the use of particulate steroids for this intervention, as a number of case reports have been published linking them with post procedural paralysis, possibly due to spinal ischaemia secondary to a steroid particulate embolism. Non-particulate, or soluble steroids, are mooted as an alternative; however, their effectiveness relative to particulate steroids has not been conclusively proven.

RESULTS: 

Four online libraries were searched, with a combined total of 11,353 titles reviewed, not excluding duplicates. Post title abstract and full text review, nine articles were identified as suitable for inclusion for qualitative synthesis. Four of these were suitable for quantitative synthesis, with a total of 300 participants, 147 in the particulate group and 153 in the non-particulate group. Using a random effects model, the pooled standard mean difference of VAS score diminution was not significant between groups (0.31 in favour of particulates, 95 % CI -0.68 to 1.30). From our qualitative synthesis, there was a trend for greater improvement in pain scores within the particulate group. The type of steroid used did not appear to have an effect on the disability score given by patients.

CONCLUSION:

Particulate steroids are not demonstrably better in relieving pain compared to their non-particulate counterparts. In view of the concerns over the safety profile of particulate steroids, it may be prudent to switch to non particulates, or at the very least the dangers and alternatives should be flagged with the patient group as part of a shared decision making process.

Eur Spine J. 2016 Feb 12. [Epub ahead of print]

Particulate and non-particulate steroids in spinal epidurals: a systematic review and meta-analysis.

Feeley IH1,2, Healy EF3, Noel J4, Kiely PJ4, Murphy TM4.

Author information

1RCSI, 123 St Stephens Green, Dublin, Ireland. [email protected].

2AMNCH, Tallaght, Dublin, Ireland. [email protected].

3RCPI, Setanta Place, Dublin, Ireland.

4AMNCH, Tallaght, Dublin, Ireland.

http://www.ncbi.nlm.nih.gov/pubmed/26873103

Transforaminal epidural steroid injections (TFESIs) are associated with rare but devastating neurologic complications. Every published case has been associated with a particulate steroid suspension, and the presumed but not proven mechanism is embolization and occlusion of end arterioles. Through an in vivo murine model and in vitro experiments on human red blood cells (RBCs), the study by Laemmel et al (1) in this issue of Radiology elucidates the potential mechanisms for steroid-induced vascular compromise. Unlike dexamethasone (a nonparticulate steroid solution), saline, and the particulate steroid cortivazol, other particulate steroids (prednisolone, methylprednisolone, and triamcinolone) caused often immediate and complete cessation of capillary blood flow, with RBC (not steroid particle) aggregates and alteration of RBC morphologic structure into spiculated RBCs. Thus, the study strengthens evidence in support of the higher safety profile in TFESI for dexamethasone, the nonparticulate and U.S. Food and Drug Administration-recommended steroid of choice, compared with particulate steroids. The results should not be considered proof that cortivazol has not or could not cause neurologic infarction during a TFESI. Rather, experiments such as those by Laemmel et al should foster more research, particularly in the arena of novel therapeutic agents (nonparticulate steroids and nonsteroidal drugs alike).

http://www.ncbi.nlm.nih.gov/pubmed/27183400

This is latest results fron an article in regards to the comparative efficacy of particulate versus non-particulate corticosteroids for cervical and lumbosacral epidural steroid injections (ESI) in reducing pain and improving function.

There is no statistically significant difference in terms of pain reduction or improved functional outcome between particulate and non-particulate preparations in cervical ESI and therefore, the authors recommend using non-particulate steroid when performing cervical TFESI (Grade of Recommendation: B). In patients with lumbar radiculopathy due to stenosis or disc herniation, TFESI using particulate versus non-particulate is equivocal in reducing pain (Grade of Recommendation: B) and improving function (Grade of Recommendation: C) and therefore the authors recommend the use of non-particulate steroids for lumbar TFESI in patients with lumbar radicular pain (Grade of Recommendation: B). There is insufficient information to make a recommendation of one steroid preparation over the other in lumbar ILESI (Grade of Recommendation: I). Given the lack of strong data favoring the efficacy of one steroid preparation over the other, and the potential risk of catastrophic complications, all of which have been reported with particulate steroids, non-particulate steroids should be considered as first line agents when performing ESIs.

https://www.ncbi.nlm.nih.gov/pubmed/27915069