APDU Alert to the American Society of Anesthesiologists: Inappropriate and Unsafe Use of Depo-Medrol in Spinal Pain Patients.

The Following APDU warning letter was sent to the Chief Quality Officer at the American Society of Anesthesiologists (ASA), Dr. Alexander Hannenberg. This warning is generated based on the APDU’s understanding that a vast majority of anesthesiologists across the United States are performing Epidural Steroid Injections using the drug Depo-Medrol, without their patients’ full informed consent. This is a potentially dangerous treatment given the serious contraindications and warnings on the product label regarding exposure of this slurry substance into the neuro-axial space. With this public letter of warning, the ASA has an ethical (and potentially legal) obligation to issue a strict guidance to all anesthesiologists to use Depo-Medrol selectively and with objective and full informed consent from the patient being treated.

Alexander Hannenberg, MD

Chief Quality Officer,

American Society of Anesthesiologists

November 10, 2017

Re: Unsafe and Inappropriate Use of Depo-Medrol For Management of Spinal Pain

Dear Dr. Hannenberg,

You are receiving this public Alert letter from the American Patient Defense Union in your capacity as Chief Quality Officer of the American Society of Anesthesiologists. This patient safety warning is being issued to the ASA, because it has come to our attention that a steroid “depo” preparation, marketed by Pfizer as Depo-Medrol, is being used in a large numbers of your patients across the United States as an Epidural Steroid Injection (ESI) for the management of spinal radiculopathy. The Depo-Medrol ESIs are being performed widely by anesthesiologists, and pain specialists, across the United States without the informed consent of patients as to the potential serious adverse neurological outcomes associated with its use in the neuro-axial anatomic space.

Dr. Alexander Hannenberg. Chief Quality Officer at the American Society of Anesthesiologists.

Please note, that The Union represents the interests of American patients who reach out to us voluntarily for help. Our objective is to provide transparent feedback to specific providers, hospitals, insurers and drug/device manufacturers, on behalf of individual patients and their families when grievances arise. The goal is to improve our nation’s Healthcare establishment by addressing real or perceived safety hazards and ethics violations across the United States — in order to create a maximally patient-centered corporate healthcare environment in deeds, not just in words. Additionally, we are interested in identifying medical ethical violations and corrupted or unsafe practice patterns within our corporate healthcare establishments. Please note that The Union is NOT a legal firm, but in cases where litigation becomes appropriate, we do support our members in seeking robust legal support.

To be clear, The Union recognizes that Pfizer, in accordance with FDA requirements, has a contraindication for intrathecal injection and a serious warning label for epidural injection already printed on the Depo-Medrol package insert. However, as the ASA is likely well aware, Depo-Medrol is in wide use by anesthesiologists for injection into the neuro-axial space. The Union is seriously concerned that these injections are occurring with an unacceptable degree of laxity, despite a serious FDA contraindication and the warnings on the drug’s packaging. Certainly, only a minority subset of patients have access to the drug’s package inserts, or are even told what drug is being used by their anesthesiologist. It is a striking violation of ethical and good practice standards in medicine for the vast majority of anesthesiologists to not be informing their patients that they will be treated with this drug — or that it could have very serious neurological adverse events associated with its use.

Pfizer and FDA have clear knowledge of the range of debilitating and potentially permanent neurological complications caused by Depo-Medrol when it is exposed to the intrathecal space — as this knowledge has served to inform the package warnings and contraindications. When the Depo-Medrol slurry, which contains Ethylene Glycol (i.e., a relative of Windshield wiper and radiator coolant fluids) is introduced into the epidural space, the chances of a breach of this caustic slurry substance into the nearby arachnoid space is not insignificant — be it due to a mechanical traumatic injury to the dural membrane or due to a physiological defect in the Dura connecting the epidural space with the arachnoid space. In addition, the notion that performing an ESI under fluoroscopy is sufficient in excluding the possibility of a dural breach by depo-Medrol is simply wishful thinking.

Therefore, with this letter, on behalf of susceptible, but unsuspecting, patients across the United States, The Union is requesting the ASA’s prompt attention and action in two specific domains:

1) Anesthesiologists at private and hospital-based practices across the United States are widely using Depo-Medrol for ESI — in what is a profitable practice pattern. This use is occurring, in many if not most cases, WITHOUT informed consent, or even knowledge, of the patients about the use of Depo-Medrol — much less its associated neurological complications. As such, The Union is formally, and on the record, requesting that the ASA immediately issue a directed and public warning to all pain practitioners guiding them to provide every patient undergoing ESI with Depo-Medrol full informed consent — both regarding the potentially devastating consequences of intrathecal exposure, as well as about the incredibly close anatomic proximity of the epidural and intrathecal spaces and the about the possibility of dural membrane breach during an ESI. Without immediate input from ASA to pain practitioners, Depo-Medrol’s package insert is 100% insufficient in protecting patients through the informed consent route. With this letter we ask that you and the ASA leadership carefully consider your clear ethical duty to ensure that all pain practitioners are delivering this potentially dangerous drug into the epidural space with extreme caution and with the patient’s full informed consent. It is not an acceptable option for thousands of patients to be kept in the dark by anesthesiologists about the caustic adverse outcomes associated with the neuro-axial delivery of Depo-Medrol — particularly given the serious contraindications and warnings from the manufacturer and FDA on the packet insert.

2) It is likely that neurological complications associated with the use of Depo-Medrol are being under-reported or misdiagnosed by practitioners and misunderstood by a significant number of affected patients — especially, given that most patient undergoing these injections start out having radicular pain symptoms. So it is easy to see how the additional symptoms caused by Depo-Medrol would be attributed to the patient’s intrinsic disease and not to the drug. As such, The Union is requesting that the ASA immediately call for a prospective surveillance study to determine the incidence of de novo neurological complications following ESI using Depo-Medrol. However, it would also be a cogent and safe maneuver to recommend termination of this drug’s use as an epidural injection.

In summary, the ASA must urgently address the fact that a vast number of pain specialists in the United States are using Depo-Medrol for epidural injections, with the very real possibility of intrathecal exposure, and without informing their patients of the potentially catastrophic neurological consequences, both the manufacturer and FDA are warning against, when the slurry emulsion accesses the arachnoid space.

Finally, Dr. Hannenberg, The Union is writing you as the Chief Quality Officer at the most prominent guild to which a vast number of pain practitioners belong. We write in order to partner with you to eliminate what is likely the cause of an under-appreciated but serious harm to many unsuspecting patients with spinal pain. The Union is concerned that this harm is caused by the lax standards applied by the anesthesiologists using Depo-Medrol and is lubricated by the lucrative practice pattern that has evolved around its use. The Union is confident that you will agree that tolerating avoidable collateral damage to a minority subset of unsuspecting patients for the real or presumed benefit of the majority is fully inconsistent with the principles of medical ethics and lawful conduct in America. Therefore, with this letter submitted to your attention, we are confident that the you and your colleagues at the ASA will recognize your a ethical duty to issue a stern warning to all anesthesiologists to immediately institute highly stringent and objective standards for obtaining informed consent when considering the use of Depo-Medrol for the treatment of spinal radiculopathy.

With this letter, The Union and the public consider the ASA leadership aware of what is a large-scale inappropriate and dangerous use of Depo-Medrol in the epidural anatomic space of unsuspecting patients across the United States and world, without informed consent. We appreciate your focused attention and public action on this issue — in order to protect unsuspecting patients everywhere.

We look forward to hearing from you, to seeing you demonstrate your friendship to American patients and to The Union’s systemic patient safety agenda. Please do not hesitate to contact us with your questions or comments at info@patientrights.org.

Very Sincerely,

Hooman Noorchashm MD, PhD

Founder, American Patient Defense Union.