Dr. Joye administering an epidural

The use of steroids in epidural injections has been considered “off-label” for many years, but it shouldn’t detract from the fact that there have been several properly conducted randomized trials and systematic reviews (as well as guidelines), showing significant long-term effectiveness of using them. Hundreds of thousands of patients every year avoid potentially unnecessary spine surgery and lead active and productive lives.

“Off label” medical innovations

The use of medications and procedures considered “off-label” by the FDA has led to medical innovations that likely would have been unrealized (or at least significantly delayed) otherwise. To the best of my knowledge, the FDA considers the use of vein grafts “off-label” for heart bypass operations, yet more than 200,000 patients undergo this surgery every year in this country.  In general, physicians are more concerned about whether a medication or device will work for a patient’s specific condition rather than whether or not the use of the medication or device is “off-label”.

 

Standard of Care

An “off-label” designation for a medication or device doesn’t mean that it is illegal, or is being used in the wrong way, or is “contraindicated”, or is not consistent with standard of care .  It simply means it is being used in a way that is not part of its FDA clinical approval.  By the time most patients reach me, they have exhausted conservative care options.  They are seeking relief of pain, and I am tasked with using my best medical judgment to make a positive difference in their lives.

Safety alert

Yet this week, the FDA issued a safety alert warning that injections of corticosteroids into the epidural space of the spine may result in rare but serious neurological problems. In addition, the advisory also stated that epidural steroid injections are not effective. While the FDA is justified in issuing such warnings, this specific warning is based on inappropriate interpretation of data.

Oral opioid overdoses cause 16,000 deaths per year

To be sure, there are potential complications with epidural steroid injections, which primarily involve infection, bleeding, where the injection is placed, and the choice of medication used in the injection. Risks are considered every day by physicians who, not only treat conditions using medical procedures, but also the use of oral medications. Opioid overdose deaths are about 16,000 per year, more than motor vehicle accidents. But the FDA has recently approved, under considerable opposition, a new combination opioid, Zohydro, despite their own advisory panel voting 11 to 2 against it (without a single scientist or physician voting for it).

Merits of epidural steroid injections

In issuing this warning, the FDA has sparked a good national debate on the merits of epidural steroid injections. But let’s also look at a key safety issue that, unfortunately, the FDA has failed to adequately address – nurse anesthetists (and other medical providers) performing these injections without advanced medical training. Perhaps the administration could also give us its opinion on proper selection criteria and appropriate provider training to safely perform these injections too.

Benefits far outweigh risks for many patients with chronic pain

No doctor (or patient) ever wants a serious complication to occur. These injections, when properly performed under fluoroscopic guidance by highly trained physicians, help hundreds of thousands of patients every year lead productive lives and avoid potentially unnecessary spine surgery.

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