Wednesday, January 18, 2012

FDA Questions Safety of Epidural Steroid Injections

The gang over at Raizman Frischman & Matzus, a great Pittsburgh, Pennsylvania personal injury law firm posted an interesting article about how the FDA is investigating various complications related to epidural steroid injections.

Epidural steroid injections (ESIs) are consistently used to treat many forms of low back pain and leg pain. They have been used for low back problems since 1952 and are still replied upon heavily in the non-surgical management of sciatica and low back pain.
An epidural steroid injection delivers steroids directly into the epidural space in the spine.  Additionally, doctors will sometimes opt to use fluid (local anesthetic and/or a normal saline solution) to help ‘flush out’ inflammatory factors in and around the area of pain.  Doctors usually use a solution containing cortisone (steroid) with local anesthetic (lidocaine or bupivacaine), and/or saline is used.

Anatomically, the epidural space circles the dural sac and is filled with fat and small blood vessels. The dural sac then covers the spinal cord, nerve roots, and cerebrospinal fluid.

Due to an increase in the number of reported complications (all different types apparently), the FDA is reviewing the safety of these injections into the backs of patients.

The  Raizman Frischman & Matzus blog reports that in 2007 one man went into a locked-in-state after receiving an epidural steroid injections. Seconds after the shot was given, the left side of his body appeared to suffer a stroke. A breathing tube ended up being inserted, and surgery was done to relieve swelling on his brain.  Three weeks after those shots were administered the man was stuck in a state where he could hear and see, but was not able to actually respond because his muscles were paralyzed.At this point, the man has been able to once again speak. But in a lawsuit, he claims he was not warned that the shot could result in a brain injury, and that if he had known this, he most likely would not have gone through with the procedure.

Unfortunately, there is little literature with respect to the mechanism of injury.  It is unclear whether the injections are causing problems because there are being administered incorrectly- possibly impacting the spinal cord physically or whether it is the steroid solution that is causing the problems.  Area residents with persistent back pain that look to ESIs for relief will want to ask their doctors some additional questions about the efficacy of these injections during their next appointment. Share this post :
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  1. It also caused Arachnoiditis which is lifetime misery.

  2. Kenalog was used and entered spinal cord.