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 http://www.fda.gov/Safety/MedWatch/ or 800-332-1088.