Another Warning: FDA Advisers Tackle Epidural Steroid Shots

FDA Advisers Tackle Epidural Steroid Shots

An FDA advisory committee is meeting Monday and Tuesday to discuss adverse neurologic effects following the use of epidural steroid injections for pain management.

Since doctors are much less inclined to prescribe opiates, more desperate patients are trying these risky “Interventional Pain Management” techniques.  The clinics for these procedures are extremely profitable and are often run by doctors that are campaigning against opiates. (See Pain Management: Surgery but Not Opiates)

Finding little relief for back and neck pain from analgesics or surgery, patients have turned to injectable steroids, but increasing reports of “catastrophic consequences,” including neurologic injuries, has put the treatment under scrutiny.

While the FDA has not approved injectable corticosteroids for use through epidural injection, the products continue to be used off-label.

In April, after reviewing the medical literature and its own adverse event database, the FDA ordered a label warning for epidural injections to include the risks of severe adverse events (death, stroke, permanent blindness, and paralysis).

While these events are considered rare, the agent said the severity of potential outcomes warranted a written caution. The agency advised healthcare providers to discuss the risk of these injections with their patients, as well as signs of potential adverse neurological effects, including loss of vision, numbness, tingling, severe headaches, or seizures.

In October, the FDA’s department of pharmacovigilance published a review of injectable steroids that included records from its adverse events database. A summary of its findings was included in the briefing documents released in advance of this week’s meeting.

The briefing document is truly frightening and worth a look.

The department’s analysis found 131 cases of serious adverse neurological events including 41 cases of arachnoiditis — a chronic pain condition involving inflammation of membranes surrounding spinal cord nerves — after epidural injections.

The review also found “general consensus” that transforaminal injections into the opening of the spine where a nerve root exits were riskier than interlaminar or caudal injections.

Several previous posts on epidural injections:
https://edsinfo.wordpress.com/?s=epidural+injection

8 thoughts on “Another Warning: FDA Advisers Tackle Epidural Steroid Shots

  1. painwithdignity

    Note that of the 41 patients with arachnoiditis, only 2 (TWO!!!) were reported by physicians. #( of the reports of this extremely severe and incurable chronic pain condition came from victims themselves. Now it is not an easy task to complete a report for the FDA and there are many, many victims who will simply not have the resources to complete a complaint form. The most striking feature of this stastic: The total lack of participation of the doctors doing the injections in reporting these complications. In my opinion, based on my experience when I was in practice, most of the doctors doing the injections do not follow the patients on a long term basis and therefore they would never see the complications. They wall themselves off from the chronic patients so that they do not have to deal with “those” patients. Shame on the medical profession!

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  2. Payne Hertz

    (This site is excellent. Thank you for the time you take to identify and comment on these articles.)

    Another issue is that no formal accreditation in pain management is necessary for doctors who want to do these shots. As far as I am aware all you need is an MD, some syringes and you’re in business. That there are a lot of quacks out there playing shot jockey may skew the safety profile of these procedures, but reigning in this highly profitable industry with some serious regulation and standards is definitely in order.

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