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FDA Hearing, November 24, 2014 


 The Hidden Risk of Exposure 

Injured Worker and Patient Input Warnings for Epidural Corticosteroid Injections 

Submittal to FDA Advisory Panel by Terri Anderson 

On behalf of NFFE Forest Service Council to Prevent Harm 

On behalf of All who suffer the Horrors of Adhesive Arachnoiditis 

November 24, 2014 

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Factors Contributing to the Hidden Epidemic of Harm 

1.Adverse events are grossly misdiagnosed 

2.The standard of care is repeated injections 

3.Studies evaluating risk are corrupted by a financial conflict of interest and lack of integrity 

4.Particle Size Distributions (PSD) of common steroid suspensions are variable in size and tendency to aggregate (depending on the steroid, diluent, and dilution ratio) 

5.Severe impacts to the central nervous system cannot be evaluated with current technology 

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FINAL Submittal FDA Hearing Nov 24 2014.jpg


Centralized Pain Conditions Not Recognized by Many Clinicians 

The U.S. Government Accountability Office reported (2000): “while adverse events have been recognized as a serious problem, the full magnitude of their threat to the health of the American public is unknown” and “gathering valid and useful information about adverse events is extremely difficult.” 

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Lumbar Transforaminal Steroid Injection with Fluoroscopy 

In 2012, The Doctors Company reported: "Fluoroscopy, while advocated as a safety measure by a number of authors clearly cannot alone prevent neurologic injury and, while quite valuable, should not provide a false sense of security.” 

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Risk Assessments Must Include Repeated Injections 

The FDA recently received a Citizen’s Petition claiming interlaminar epidural injections do not carry the same level of risk as transforaminal epidural injections. 

True risk must be disclosed for the “standard of care,” typically 3 injections within a 6 or 12 month timeframe. 

IF the error rate for dura puncture is only 0.8% for the more conservative technique (interlaminar epidurals with fluoroscopy), THEN: 3 injections results in 2.36%* risk of dura puncture 6 injections results in 4.61%* risk of dura puncture * Error Rates calculated based on Bernoulli Trials Equation (Appendix A) 

Spinal surgery adds more risk because of changes to anatomy and scar tissue, which interferes with correct needle placement 



Subarachnoid Space Dimensions vs. Particle Size Distributions 

Particles in steroid suspensions are significant in size (Benzon etal. 2007, Table 1) when compared to the thickness of the subarachnoid space, measuring an average of 2.5 mm on the right and left sides of the spinal cord, and 1 to 5 mm front and back of the cord. Limited studies focused on the cervical spine, leaving a lack of data (Zaaroor etal. 2006). 

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CSF flow studies are essential to evaluate patient harm 

The long term impacts (misplaced steroid suspensions) are absent from the literature. Technology to map CSF flow velocities and pressure gradients (lumbar cistern) is not available in the U.S. The mathematical model breaks down as flow dynamics vary significantly from the brain and cervical spine. Photo CSF Flow Study, Fonar

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Arachnoiditis: A LIVING HELL 

Many arachnoiditis sufferers consider SUICIDE as a viable option for pain relief. 

Some are coerced into more injections before they are accurately diagnosed. 

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We ask the FDA to consider Three Options: 

1.Issue a Black Box Warning for epidural use of corticosteroids containing unpredictable and unregulated Particle Size Distributions. Important Questions for the Panel are included in Slides 10 and 11. 

2.Issue a warning for steroids misused in spinal surgery. Neurotoxins placed directly over the spinal canal have resulted in adhesive arachnoiditis. 

3.At the very least, contraindicate All steroids for epidural use for patients who suffer Adhesive Arachnoiditis. Physicians are reluctant to diagnose this devastating complication. More injections results in catastrophic outcomes. 


Thank You for Listening to the Patient Perspective 

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Questions for FDA Advisory Panel 

1.Is there consistency in particle size distributions (PSD) for steroid suspensions? Why is this information not readily available from manufacturers for steroid suspensions? 

2.According to Benzon etal. (2007), the increased dilution of methylprednisolone acetate (MPA 80) with saline increases the proportion of larger particles. Cerebrospinal fluid is comprised of a large proportion of saline, or sodium (Na++) and chloride (Cl-) ions. Is it possible that the mixture of this steroid and spinal fluid results in the aggregation and formation of even larger particles after the steroid is misplaced in the intrathecal space? Note: The 2007 Benzon etal. study reveals there is variability in particle size and tendency to aggregate, depending on the steroid, the diluent, and the dilution ratio. 

3.How does the maximum particle size compare with the nominal thickness of the subarachnoid space in the cervical, thoracic or lumbar spine? In males? In females? 

4.How do steroid suspensions impact CSF flow velocities and pressure gradients when injected into the subarachnoid space? 

5.How do misplaced steroids affect the permeability and hydraulic conductivity of the arachnoid membrane? 

6.What happens when large particulate matter is transported by spinal fluid to the brain? NOTE: These questions do not address intravascular complications, or harm to neural tissues caused by neurotoxic preservatives in steroid suspensions. 

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References 

1.Aldrete, A (2012). Arachnoiditis, The Evidence Revealed. 

2.Bartynski WS, Grahovac SZ, Rothfus WE. Incorrect needle position during lumbar epidural steroid administration: inaccuracy of loss of air pressure resistance and requirement of fluoroscopy and epidurography during needle insertion. AJNR Am J Neuroradiol. 2005 Mar;26(3):502-5. 

3.Benzon HT, Chew TL, McCarthy RJ, Benzon HA, Walega DR (2007). Comparison of the particle sizes of different steroids and the effect of dilution: a review of the relative neurotoxicities of the steroids. 

4.Derby R, Lee SH, Date ES, Lee JH, Lee CH (2008). Size and aggregation of corticosteroids used for epidural injections. 

5.Donaldson S, Aldrete, A (2012). ABC News: Epidural Steroid Injection Risks Include Incurable Arachnoiditis. 

6.Damadian R, Chu D (2011). MRI Cines of CSF Flow Obstruction in 8 Multiple Sclerosis Patients. 

7.Guarino A (2006). Observational Study of Dural Punctures, A retrospective review of the rate of dural punctures as a complication of lumbar epidural steroid injection—with and without guiding fluoroscopy. 

8.Manchikanti L, Malla Y, Wargo BW, Cash KA, Pampati V, Fellows B. A prospective evaluation of complications of 10,000 fluoroscopically directed epidural injections. Pain Physician. 2012 Mar-Apr;15(2):131-40. 

9.Nelson DA, Landau WM (2000). Intraspinal steroids: history, efficacy, accidentally, and controversy with review of United States Food and Drug Administration reports. 

10.Pfizer NZ (2014). Medsafe New Zealand, Depo-Medrol datasheet, http://www.medsafe.govt.nz/profs/datasheet/d/Depomedrolinj.pdf 

11.Tennant F (2014). Practical Pain Management, Adhesive Arachnoiditis Part 1: Clinical Description. 

12.The Doctors Company (2012). Complications of Cervical Epidural Steroid Injections: A review of medical malpractice claims. 

13.U.S. Government Accountability Office (2000, Feb. 9). Surveillance Systems for Adverse Events and Medical Errors. 

14.Zaroor M, Kósa G, Peri-Eran A, Maharil I, Shoham M, Goldsher D (2006). Morphological study of the spinal canal content for subarachnoid endoscopy. Minim Invasive Neurosurg. 2006 Aug;49(4):220-6 

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