FDA Warns Against Certain Particulate Steroid Injections for Back Pain
The U.S. Food and Drug Administration’s (FDA’s) Anesthetic and Analgesic Drug Products Advisory Committee has concluded that epidural steroid injections (ESIs) should be contraindicated for transforaminal injections in the cervical region for the treatment of back pain.
ESIs Linked to Irreversible Adverse Events and Death
According to Medscape, committee members came to an agreement that the injection of particulate steroids in to the cervical region by a transforaminal approach can result in an increased risk of serious and irreversible neurological events.
Adverse events considered by committee members included:
- Spinal cord infarction
According to one panel member, James Eisenach, MD, professor of anesthesiology and physiology and pharmacology at Wake Forest School of Medicine in Winston-Salem, North Carolina, the occurrence of such events is supported by theoretical evidence as well as data from animal testing and patient reports.
What is a Transforaminal Approach?
A transforamal epidural steroid injection is a process in which medication is injected into a small lateral opening between to vertebrae. This opening is known as the foranimae.
While such injections can be used at the cervical, thoracic, and lumbar levels, committee members limited their concerned with the injections completed in the cervical area.
Members voted 15 to 7 there are clinical situation in which contraindications to ESIs are warranted. Other members believed a warning on the product label would have been sufficient.