FDA Panel Addresses Neurologic Risks of Epidural Steroid Injections

A review of events reported to the FDA’s Adverse Event Reporting System (FAERS) between November 1997 and April 2014 identified 90 cases of serious neurologic events associated with ESIs, including quadriplegia in a 53-year-old man who developed weakness in the left arm and both legs shortly after a triamcinolone injection – an MRI showed a diffuse vascular infarct to the cervical cord. As of April 2014, the FDA also received 41 reports of arachnoiditis in patients being treated for a variety of indications, most often unspecified back pain.

As with the FAERS data, cases identified in a medical literature review of studies between August 2012 and August 2014, also presented by the FDA at the meeting, were diverse. Cases were reported with cervical and lumbar TFA and interlaminar injections. No catastrophic cases associated with nonparticulate (solution) formulations were reported, but it is unclear whether that is related to the safety profile or lower use of nonparticulate formulations, according to the agency.

One of the panelists, Dr. Michael Sprintz, chief medical officer of the Sprintz Center for Pain and Dependency, The Woodlands, Tex., cautioned that the consequences of not having ESIs available should be considered. “By limiting patient access to these procedures, most pain docs are left with very little” to help these patients, which could result in a “massive increase” in opioid prescriptions, he said.

There are five injectable corticosteroids marketed in the United States: betamethasone, dexamethasone, hydrocortisone, methylprednisolone, and triamcinolone. In 2011, a statement was added to the labeling of injectable triamcinolone (Kenalog-10 and -40), manufactured by Bristol-Myers Squibb, that it was “not for epidural or intrathecal use.”

In 2013, about 420,000 people aged 65 years and older received ESIs, based on Medicare data, and about 604,000 people younger than 65 years in a national database of commercially insured patients also received ESIs. Both figures represent increases since 2009, according to the FDA. In both groups, almost half were TFA injections, most steroids used were suspensions, and more than one-third of the ESIs used were steroid suspensions administered by the TFA route.

The panelists had no conflicts to disclose. The FDA usually follows the recommendations of its advisory panels.

Serious adverse events associated with the use of epidural steroid injections should be reported to the FDA’s MedWatch program at https://www.fda.gov/Safety/MedWatch/ or 800-332-1088.