FDA Drug Safety Communication on Risk of Rare But Serious Neurologic Problems from Epidural Corticos
Thursday, April 24, 2014
FDA Drug Safety Communication on Risk of Rare But Serious Neurologic Problems from Epidural Corticosteroid Injections
By now you have likely seen the FDA's Drug Safety Communication regarding the risk of rare neurologic problems from epidural steroid injections. As interventional spine providers, we trust that you are aware of these potential risks. We applaud the FDA on their effort to address risks via updating the warning labels to ensure physicians and patients are aware of potential complications related to drugs and medications. The risks and benefits of treatments should be openly disclosed by physicians and considered by patients when determining how best to proceed.
Unfortunately, the FDA's Drug Safety Communication is misleading. Of concern to our members and patients is the statement in the notice that "the effectiveness and safety of epidural administration of corticosteroids have not been established." This simply is not true. We want to assure you that ISIS is working on your behalf to respond to the FDA and provide information for you to share with your colleagues and patients to correct the misinformation provided in that communication.
There is ample evidence demonstrating effectiveness of epidural steroid injections in reducing and eliminating pain, improving function, decreasing reliance on opioids, and eliminating the need for surgery for many patients. The ISIS Practice Guidelines, along with recently published systematic reviews addressing epidural steroid injections, summarize the evidence regarding the different types of epidural injections. It will be imperative to educate the FDA, our colleagues, and our patients about the different effectiveness and safety information about different types of injections.
In the meantime, we urge you to continue to follow the recommendations made within the ISIS Practice Guidelines related to technique. Also continue to discuss both the risks and benefits of any procedures with your patients.
Jeffrey T. Summers, MD