FDA Letter June 2012: Arachnoiditis as a Complication of Epidural Steroid Injections
To: Margaret Hamburg, M.D., FDA Commissioner
Richard Rosenquist, M.D., Cleveland Clinic;
James Rathmell, MD, Massachusetts Gen.
Hospital
Laxmaiah Manchikanti, MD, Pain Managmt.
Center of Paducah;
Sandy Walsh, FDA.
June 8, 2012
An Appalling Toll: Arachnoiditis as a Complication of Epidural Steroid Injections
Dear Dr. Manchikanti,
I understand the FDA is currently reviewing the safety of epidural steroid injections (ESIs). I am writing to represent my experience, and that of thousands of people suffering from arachnoiditis, a poorly understood and devastating complication of ESIs. Based on our experiences and the findings and opinions of a growing number of experts, (Charles V. Burton) (Esther M. Benedetti, 2009) (Dr. Sarah Fox, 2005) (Dr. Aldrete, 2010), I urge your committee to consider the following steps to protect others from suffering the devastating effects that are associated with ESIs:
• More comprehensive training and oversight of physicians performing ESIs;
• Adequate patient consent forms that clearly include arachnoiditis as a potential outcome;
• Better long-term tracking and reporting of adverse events from ESIs;
• Better guidelines for doctors on ESI contraindications;
• Prohibition of coercive pain management practices.
In my journey to understand more about arachnoiditis, I have encountered many others who either contracted the disease from ESIs or were made drastically worse by them. As you will see, their stories are horrifying and heart-breaking. It is my sincere hope that the medical community will learn from these experiences so that changes can be cane made to ensure that others will not endure such horrific outcomes.
What is Arachnoiditis?
"There exists no area of medicine today where greater, or more cruel suffering has been produced ... than that causally related to adhesive arachnoiditis. ... this disease entity remains essentially unknown, unreported and unrecognized." (Burton, 2001)
Arachnoiditis is a neuropathic disease caused by inflammation of the arachnoid membrane, which surrounds and protects the spinal cord. Inflammation can include the nerve roots. Scar tissue grows in the cerebrospinal fluid, binding nerves to each other and the posterior wall of the spinal canal, causing intractable pain and a host of other debilitating symptoms. The disease usually progresses the rest of the sufferer's lifetime. Two-thirds lose bowel and bladder function. Most end up requiring morphine. Some are even bedridden. Though it can be caused by infections or trauma to the spine the most frequent cause is medical interventions such as surgery, myleograms and epidural steroid injections.
Below is a small sample from the many stories told by arachnoiditis sufferers. Though people experience the disease differently and are disabled by it in different ways, many stories have similarities, including painful and bizarre symptoms, and the fact that many have epidural steroid injections to blame for their conditions.
Patient Stories:
Helen: A 36 year old mother of two little girls, I had no history of spinal trauma or surgery, and am a non-smoker in good health. In February 2011, suffering from the pain of a bulging lumbar disc, I went to a pain clinic and was told my ESI would be given by an experienced doctor. Instead it was given by a trainee with little experience. The procedure was excruciatingly painful, and within a week I was experiencing strange new symptoms. My pain and symptoms have since worsened, and I was finally diagnosed with arachnoiditis in August, 2011.
Formerly the VP of a communications firm, an active mom, avid hiker and runner, I now endure pain and symptoms every day, including severe stabbing pains and electric shocks, muscle cramps and fasciculations, strange sensations akin to water running down my legs or insects crawling and biting me, extreme fatigue, etc. The toll that this has taken on my family emotionally, financially and physically, is terrible. I feel I have been dropped into a nightmare with no hope of waking up.
***
Matthew: Matthew is a 41 year old father of two living in Tennessee. In 2003 he received epidural steroid injections for back pain. Hours after his last shot, he found that portions of his intestines had dropped into his underwear. At the time his doctor explained that he had injected so much of the drug that his sphincter muscle had relaxed. Years passed with increasing pain and symptoms. However, without diagnosis, Matthew was unable to receive disability. Eventually he began to have episodes of passing out at work and waking up with vomit on his shirt. He also developed symptoms such as fasciculations, stabbing in his feet and limbs, invisible insects on his skin, and so on. At this point he visited another neurosurgeon who diagnosed arachnoiditis after a myleogram and told Matthew that his intestines dropping out is a classic sign of spinal injury.
In Matthew’s words: “I am in so much pain, I have been robbed of so many things, and I am told that it is only a matter of time before I am in a wheelchair. I don't want to hurt my family but I truly would pick death over this disease.”
***
Dawnelle: Dawnelle is a 33 year old mother of two little girls living in South Carolina. She has no history of back trauma or surgery. Dawnelle contracted arachnoiditis during an epidural for childbirth in 2008. It was excruciating, and afterward Dawnelle began to experience pain and strange symptoms. By January 2010 her symptoms had worsened, so she visited her GP seeking help. He ordered an MRI, but the radiologist reading the films did not recognize the signs of arachnoiditis.
Dawnelle was then sent to a pain clinic where she was told that, in order to receive pain management treatment, she had to agree to a series of three epidural steroid injections. After the first ESI, Dawnelle lost hearing for ten minutes, and became nauseated and dizzy. She could not lift her legs because of pain. Nonetheless, she was given two more ESI’s, each a month apart, and after each her symptoms drastically worsened until she lost bowel and bladder control and could no longer walk. She also experiences electric shocks and stabbing pains in her limbs, fasciculations, and the sensation that water is running down her legs. Dawnelle was finally diagnosed with arachnoiditis in September 2011, and the diagnosing physician immediately recognized the disease on the January 2010 MRI films.
It is believed that any spinal procedure conducted on a patient with arachnoiditis has a very real risk of making the disease much worse. Not only did Dawnelle's doctors not recognize the disease on her MRI, they inappropriately recommended ESIs as treatment, leaving Dawn profoundly and permanently disabled and unable to care for her children or even herself. In Dawn’s words: “This disease has ripped me from the lives of my children and husband, and I don’t recognize the person I have become. I can no longer care for my family the way I once did, and now just caring for myself on most days is a struggle. I am facing the majority of my life in excruciating pain, and not once was I warned of this when I consented to having an ESI to try to relieve pain that was nowhere even close to what I am forced to deal with now."
***
Layla: Layla was an otherwise healthy 36 year old with no history of back trauma or surgery. After suffering back pain in 2005, she was given a series of three ESIs at a pain clinic. After that, her pain gradually worsened until, in December 2008, she began experiencing back and abdominal pain so severe she went to the ER three times in one week. She needed narcotic medicine just to bring the pain to a level of 6-7 out of 10. Finally in April 2009 her doctor ordered an MRI and discovered arachnoiditis in Layla’s spine.
Despite the fact that Layla’s doctor has confirmed arachnoiditis is the cause of her intractable pain, he continues to press her to have more epidural steroid injections. In Layla’s own words: “I finally had to say to my doctor ‘I will agree to have more ESIs if you will put in writing that you believe the ESIs won’t worsen my condition,’ after which he backed, off muttering that his lawyers wouldn’t let him do that. I was a healthy woman with a promising career. I am now bedridden many days with pain I cannot control. To say that arachnoiditis has decimated my life is an understatement. I am terrified of the future.”
***
Tahnee: The mother of three-year-old twin girls, Tahnee contracted arachnoiditis in 2009 from an epidural for childbirth. By 2011 her pain had worsened and she sought medical help near her home in Colby, Kansas, but was turned away from a pain management clinic for refusing epidural steroid injections. In late 2011 Tahnee received the diagnosis of arachnoiditis from two specialists.
When she returned to the clinic with her diagnosis, in her words: “I was shocked when the doctor dismissed me, saying ‘There are no side-effects whatsoever from epidurals, Arachnoiditis is hogwash.’ He then again refused to prescribe any pain treatment other than ESIs. To be in such pain every day is terrible. To know I will never be the mother I dreamed I would be is awful. But to be treated so badly by a doctor for just refusing more invasive procedures is simply appalling. I have to wonder, why don’t they know more about the procedures they so vehemently insist on? And whose interests do they really have at heart?”
Recommendations:
As appalling as these stories are, most distressing of all is that these lives have been ruined by a procedure that has, at best, an equivocal track record in medical studies (C Price, 2005) (Carmel Armon, 2007). Yet the procedure’s chequered history does not seem to deter doctors, some of whom have alarmingly limited training in the administration of ESIs, from performing it on patients millions of times each year.
For the sake of these patients, and the thousands of sufferers of arachnoiditis and other serious ESI adverse events, the FDA’s review should include the following:
• More Comprehensive Training and Oversight of Physicians Performing ESIs: Both human and animal studies reveal that the inadvertent intrathecal injection of any substance can cause neuropathological effects including arachnoiditis, (Huston, 2009) (DA., 1988) (Latham JM, 1997) (Nelson DA, 1972). Therefore, it is critical that physicians performing ESIs be trained and properly credentialed to avoid such catastrophes. Credentialing committees ensure training of physicians performing epidurals in hospitals. However, no such oversight exists for physicians in other settings, such as private clinics, where millions of ESIs are delivered every year (Armstrong, 2011). More comprehensive, mandatory training and oversight of the growing number of physicians performing ESIs is critical.
• Adequate Patient Consent: Arachnoiditis is a recognized complication of ESIs, and some authors suggest that arachnoiditis can arise in susceptible individuals even in the absence of complications such as inadvertent dural puncture (Fox, 2005) (Aldrete, 2010). Given this and the devastating impact the disease has on patients and families, adequate informed patient consent is critical. Unfortunately, arachnoiditis is rarely, if ever, mentioned to patients or included on patient consent forms. (Burton)
• Adequate Tracking and Reporting of Adverse Events: Most patients are not informed of the potential for developing arachnoiditis from ESIs because their physicians believe the risk is negligible and therefore not worth mentioning. But how rare is arachnoiditis? Nobody knows for sure because no statistics are kept on it. Arachnoiditis can arise quickly or slowly, showing up on MRIs days, months or even years after the ESI. It is critical that doctors who perform ESIs track their patients and monitor for adverse events such as arachnoiditis, and report them to the FDA.
• Prohibition of Coercive Pain Management Practices: Many pain clinics have a “one size fits all” policy of administering ESIs to back pain patients before prescribing other forms of medication. Unfortunately, for those who are susceptible to developing arachnoiditis, or those who already suffer from it, this can be catastrophic. The FDA should immediately put an end to coercive practices that push many unknowing and even unwilling patients into receiving ESIs. An alarming number of sufferers report that their pain clinics refuse to offer other treatment options until they have submitted to epidural steroid injections. One diagnosed arachnoiditis patient with worsening symptoms reports her doctor states he will not order a new MRI until she agrees to ESIs; this despite the fact that ESIs given to arachnoiditis sufferers carry a very real risk of making the disease much, much worse.
Conclusion:
In your investigation into the safety of epidural steroid injections, I hope that:
• Arachnoiditis will be addressed;
• You will consider ways to ensure the proper training and credentialing of all doctors who perform ESIs;
• You will ensure adequate patient informed consent before these procedures;
• You will consider ways to improve physician training in the contraindications of ESIs to help avoid these catastrophic outcomes;
• You will modify the reporting mechanisms so that long-term monitoring of ESI patients will be ensured and critical information on negative outcomes like arachnoiditis can be collected.
Thank you for your time and your consideration. I look forward to hearing more about the Advisory Group’s work and would like to offer my assistance in any way that is needed or appropriate.
Works Cited
Armstrong, D. (2011, 12 28). Bloomberg: Epidurals Linked to Paralysis Seen with $30 Billion Pain Market. Boston, MA, USA.
Burton, C. (2001, June 30). Arachnoiditis Coalition. Retrieved from Lumbo-Sacral Adhesive Arachnoiditis, An Introduction: http://users.ecs.soton.ac.uk/harnad/Temp/Ros/burton1.pdf
C Price, N. A. (2005). Cost-effectiveness and Safety of Epidural Steroid Injections. Health Technology Assessments, 39.
Carmel Armon, M. M.-M. (2007). Assessment: Use of epidural steroid injections to treat radicular lumbosacral pain. Neurology, Abstract.
Charles V. Burton, M. (n.d.). Epidural Steroid Injections - The Burton Report Summary. Retrieved June 2012, from The Burton Report: http://www.burtonreport.com/infspine/EpiduralSteroidSummary.htm
DA., N. (1988). Dangers from methylprednisolone acetate therapy by intraspinal injection. Arch. Neurology, 45:804-6.
Dr. Aldrete, J. (2010). Arachnoiditis: The Evidence Revealed. San Rafeal: Impresioes Editoriles.
Dr. Sarah Fox, D. (2005, March 3). "Risks" [of Epidural Steroid Injections]. Retrieved March 31, 2012, from The A Word: http://www.theaword.org/index.php?option=com_content&view=article&id=358:risks&catid=92:epidural-steroid-injections-the-truth&Itemid=49
Esther M. Benedetti, M. (2009). Epidural Steroid Injections: Complications and Management. Pain Management, 236-250.
Huston, C. (2009). Cervical epidural steroid injections in hte management of cervical radiculitis: interlaminar versus transformanial. A review. . Curr. Rev. Musculoskelet Med., 2:30-42.
Latham JM, F. (1997). The pathologic effects of intrathecal betamethasone. Spine, 22:1558-62.
Nelson DA, V. (1972). Complications from intrathecal steroid theraphy in patients with multiple sclerosis. Neurology, 22:454.