FDA Issues New Warning That Epidural Steroid Injections May Result in Rare but Serious Adverse Events
First and foremost, this new warning from the FDA (found at http://www.fda.gov/Drugs/DrugSafety/ucm394280.htm) is not about the recent fungal contamination problem from 2012 that resulted in additional regulation and oversight of the compounding pharmacies that mix some of the steroids used in Epidural Steroid Injections (ESIs).
Rather, this warning is for everyone who may receive ESIs and is related to rare, but quite serious, side effects which have been reported to the FDA Adverse Events Reporting System (FAERS). These side effects include loss of vision, stroke, paralysis, and death.
ESIs have been a widespread practice in the treatment of back and neck injuries for decades now. Injectable steroids are commonly used throughout the body to reduce swelling and inflammation, and this reduction in swelling in inflammation is what is being sought when steroids are injected into the epidural space of the spine, as in ESIs. ESIs are generally utilized in the treatment of back and neck injuries/pain as a conservative measure in an attempt to avoid a surgery. The idea is that the pain the patient is experiencing is being caused by pressure or impingement of the nerve as it is passing through a small space, and that if some of the swelling and/or inflammation in the area can be reduced, then the pain may be alleviated without the need for a surgery (which accomplishes the same relief of pressure from the nerve by an obviously more severe manner).
The attorneys at Clark Mason Attorneys have handled hundreds of cases involving back and neck injuries, so we are quite familiar with both ESIs and their purpose. However, what was unknown to us that came out of this new FDA Safety Announcement is that, despite the widespread use of ESIs and its incorporation into the standard of care, the FDA has never officially approved this use (ESIs) of steroids. This was certainly news to us.
Fortunately, these side effects must be rare, as the announcement indicates, as we have never had a client experience one of these outcomes as a result of an ESI. Regardless of the rarity of these outcomes, this is certainly something that patients will want to consider and discuss with their physician prior to receiving these injections as treatment for neck and back pain. In fact, the FDA announcement encourages as much. Further, it is advised that patients:
Seek emergency medical attention immediately if you experience any unusual symptoms after receiving an epidural corticosteroid injection, such as loss of vision or vision changes; tingling in your arms or legs; sudden weakness or numbness of your face, arm, or leg on one or both sides of the body; dizziness; severe headache; or seizures.
Being informed of these risks is required in order for a patient to give what is known as “informed consent” to undergo the procedure (see http://clarkmason.wordpress.com/2014/02/21/the-consent-forms-you-sign-prior-to-a-surgery-do-not-waive-your-right-to-sue-for-malpractice/ for some discussion on this).
As always, the attorneys at Clark Mason Attorneys represent individuals with their legal needs, with an emphasis on personal injury, wrongful death, and catastrophic injury cases. If you have a question or a legal issue you need assistance with, please do not hesitate to contact us.