Tuesday, April 29, 2014

FDA Orders New Warning for Epidural Steroids

Medpage Today

Injectable corticosteroids must now carry a new label warning about the risks of severe adverse effects from epidural injections including death, stroke, and permanent blindness and paralysis, the FDA said.
The agency decided that such a warning is needed after reviewing numerous reports in the medical literature and its own adverse event database.

"Serious adverse events included death, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, stroke, seizures, nerve injury, and brain edema," the FDA said in announcing the warning.
"Many cases were temporally associated with the corticosteroid injections, with adverse events occurring within minutes to 48 hours after the corticosteroid injections. In some cases, diagnoses of neurologic adverse events were confirmed through magnetic resonance imaging or computed tomography scan. Many patients did not recover from these reported adverse events."

Overall, the agency said, these events were rare, but their seriousness merited the label change.
It urged healthcare providers to discuss the risks with patients before giving injections and to instruct them to watch for adverse neurological effects such as loss of vision, numbness or tingling, severe headaches, or seizures.

The FDA emphasized that the warning is unrelated to the fungal contamination problem associated with steroids used in epidural injections in 2012 that resulted in a crackdown on compounding pharmacies.

The use of epidural injections, in my opinion, is a procedure over utilized.  Over the years I have seen both the good and bad outcomes from the procedure. Personally, I feel the best outcomes arise out of a combination of epidural with Chiropractic adjustments.  Having said that, it is rare that I recommend the procedure.  It leads to temporary reduction in inflammation without addressing the underlying mechanical issue.  Thus, many patients resort to multiple injections with the hope that the next one will CURE THEM. The delay in improving mechanical dysfunction further deepens the abnormal movement patterns giving rise to additional issues in the hips, knees and feet.  
As a society we are too quick in our judgement of treatment effectiveness.  I guess it comes from the reality that our lives are fast paced and with that comes a general disdain for anything that takes time.  Dr. Bruce Bond once said that if you are looking for quick and cheap relief you shouldn't be at a Chiropractor's office because the Medical community has quick and cheap relief down to a science.  But, if you desire true return to Health, Chiropractic has it all over Medicine.  

Dr David Marcon, DC

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