Post by 3bid on May 13, 2014 14:29:33 GMT -5
The safety and efficacy of epidural steroid injections have never been properly demonstrated.
We recently obtained documents about the efficacy and safety of steroid epidural injections using Depo-Medrol from Pfizer/Pharmacia and the United States Food and Drug Administration. This steroid is widely used "off-label" to treat chronic neck and back pain. But according to these documents, Depo-Medrol is "not FDA approved" for this use and "not recommended" by the manufacturer, yet it remains the preferred steroid by doctors!
We believe that these documents can successfully challange the widespread practice of epidural steroid injections using this unapproved and non-recommended steroid suspension. Our research clearly indicates that patients who have complained and suffered as a result of their Depo- Medrol epidurals, were widely ignored by their physicians who suppressed the data from the manufacturer. The potential for this abuse appears to be global in scale and for the lack of a better term; it's downright criminal in our opinion.
There are NO INJECTABLE STEROIDS that are FDA approved for spinal epidural use. Currently, the most common steroid is Depo-Medrol, manufactured by Pfizer/Pharmacia & Upjohn, (PP&U). As early as 1995, PP&U strongly stated, in an internal document, that they have received reports of SEVERE MEDICAL EVENTS associated with epidural injections of Depo-Medrol. Because of these reports, they posted a warning in the package insert declaring that the "epidural administration of Depo-Medrol is NOT RECOMMENDED"! But in 1997, PP&U quietly removed this statement from their Depo-Medrol package insert and buried it an internal document for limited distribution. No one yet knows exactly why this was done, but we feel they caved to industry pressure!
PP&U withdrew the warning from the drug insert with FDA approval, but it soon reappeared in an internal company document. This document is titled: "Depo-Medrol - Reformulation / Epidural Use". This document ups the package insert WARNING from "adverse effects" to "SEVERE MEDICAL EVENTS"! It's a quantum leap in grammatical terms.
The manufacturer also warns against mixing the steroid with any other chemical solution such as an anesthetic like Marcaine or Lidocaine.. These "bedside toxic brews" can be dangerously “incompatible”, thus increasing the risks of severe side effects, even when used as directed!
When Depo-Medrol is injected epidurally, mixed or not with Marcaine or Lidocaine before it’s administered, this volatile mixture has been linked to many severe adverse effects such as, Adhesive Arachnoiditis, Severe Sensory Nerve Disturbance, CNS Disturbances, Severe Infectious and Noninfectious Nerve Root Inflammation, Toxic Meningitis and Paraplegia.
So why hasn't this important information gotten out? Why is it that doctors ignore the manufacturer's WARNINGS and continue to misinform their patients of these posted drug-risk alerts?
Keep in mind that it’s not the steroid component of Depo-Medrol that prompted Pharmacia's medical ALERT. It's the KNOWN NEUROTOXIC COMPOUNDS found within Depo-Medrol, such as Polyethylene Glycol, Benzyl Alcohol, and Myristyl Gamma Picolinium Chloride, (MGPC) etc., which causes the harm associated with so many worldwide complaints! Their internal documents claim that the preservative MGPC is “not even necessary in the single dose vials”, yet they have decided to keep it in the formulation as a suspension agent. This is highly suspicious because the drug already has a suspending agent, Polyethylene Glycol!
There is a further point to add to the list of serious concerns regarding the use of epidural steroid injections for “low back pain”. It may frequently remain unseen, but the risk of blood leakage into the three intraspinal spaces should not be underestimated by either practitioners or patients. Intravascular injection occurs with caudal and transforaminal epidural steroid injection in over 10%, and with interlaminar injections in 1.9% of procedures: the incidence of laceration of blood vessels by the needle tip will not be less (1). Indeed, Igarashi et al visualized blood vessel trauma at the tip of the Tuohy needle in approximately 20% of pregnant women undergoing lumbar epidural anaesthesia, irrespective of trimester (2). 14% of punctures for spinal anaesthesia are associated with significant vascular trauma (3).
Blood in the subarachnoid, subdural and epidural spaces opens the door to inflammatory scarring around the nerve roots. Ten per cent of patients receiving “blind”epidural steroid injection hopefully do not develop a mesh of scar tissue around a nerve root, where blood has gravitated into and/or around the nerve root sleeve …….. or do they? Blood unseen, pathology unseen.
More information here: www.bmj.com/content/328/7455/1509?tab=responses
Also:
FDA requires label changes to warn of rare but serious neurologic problems after epidural corticosteroid injections for pain
Safety Announcement
[04-23-2014] 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. We 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.
Injectable corticosteroids are commonly used to reduce swelling or inflammation. Injecting corticosteroids into the epidural space of the spine has been a widespread practice for many decades; however, the effectiveness and safety of the drugs for this use have not been established, and FDA has not approved corticosteroids for such use. We started investigating this safety issue when we became aware of medical professionals’ concerns about epidural corticosteroid injections and the risk of serious neurologic adverse events.1 This concern prompted us to review cases in the FDA Adverse Event Reporting System (FAERS) database and in the medical literature (see Data Summary).2-16
To raise awareness of the risks of epidural corticosteroid injections in the medical community, FDA’s Safe Use Initiative3 convened a panel of experts, including pain management experts to help define the techniques for such injections which would reduce preventable harm. The expert panel’s recommendations will be released when they are finalized.
As part of FDA’s ongoing effort to investigate this issue, we 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.
Injectable corticosteroids include methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone. This safety issue is unrelated to the contamination of compounded corticosteroid injection products reported in 2012.
www.fda.gov/Drugs/DrugSafety/ucm394280.htm