On April 23, 2014, the Food and Drug Administration (FDA) issued a letter of warning
that injection of corticosteroids into the epidural space of the spine may result in rare,
but serious adverse events, including “loss of vision, stroke, paralysis, and death.” The
advisory also advocated that patients should discuss the benefits and risks of epidural
corticosteroid injections with their health care professionals, along with the benefits
and risks associated with other possible treatments. In addition, the FDA stated that the
effectiveness and safety of the corticosteroids for epidural use have not been established,
and the FDA has not approved corticosteroids for such use.
To raise awareness of the risks of epidural corticosteroid injections in the medical
community, the FDA’s Safe Use Initiative convened a panel of experts including pain
management experts to help define the techniques for such injections with the aim of
reducing preventable harm. The panel was unable to reach an agreement on 20 proposed
items related to technical aspects of performing epidural injections. Subsequently, the
FDA issued the above referenced warning and a notice that a panel will be convened in
November 2014.
This review assesses the inaccuracies of the warning and critically analyzes the available
literature. The literature has been assessed in reference to alternate techniques and an
understanding of the risk factors when performing transforaminal epidural injections in
the cervical, thoracic, and lumbar regions, ultimately resulting in improved safety.
The results of this review show the efficacy of epidural injections, with or without steroids,
in a multitude of spinal ailments utilizing caudal, cervical, thoracic, and lumbar interlaminar
approaches as well as lumbar transforaminal epidural injections . The evidence also shows
the superiority of steroids in managing lumbar disc herniation utilizing caudal and lumbar
interlaminar approaches without any significant difference as compared to transforaminal
approaches, either with local anesthetic alone or local anesthetic and steroids combined.
In conclusion, the authors request that the FDA modify the warning based on the
evidence.
Key words: Chronic pain, epidural injections, epidural steroids, local anesthetic,
radicular artery, complication.