An FDA advisory committee is meeting Monday and Tuesday to discuss adverse neurologic effects following the use of epidural steroid injections for pain management.
Finding little relief for back and neck pain from analgesics or surgery, patients have turned to injectable steroids, but increasing reports of "catastrophic consequences," including neurologic injuries, has put the treatment under scrutiny.
Regulators, stakeholders, and pain management experts will gather at the FDA's White Oak conference center in Silver Spring, Md., to discuss the safety of injectable corticosteroids, among other topics.
While the FDA's has not approved injectable corticosteroids for use through epidural injection, the products continue to be used off-label. The FDA does not regulate epidural injections, but it can regulate injectable medications.
In April, after reviewing the medical literature and its own adverse event database, the FDA ordered a label warning for epidural injections to include the risks of severe adverse events (death, stroke, permanent blindness, and paralysis).
While these events are considered rare, the agent said the severity of potential outcomes warranted a written caution. The agency advised healthcare providers to discuss the risk of these injections with their patients, as well as signs of potential adverse neurological effects, including loss of vision, numbness, tingling, severe headaches, or seizures.
The committee also will discuss the efficacy of epidural steroid injections and the overall risk-benefit balance of injecting steroids in the epidural space to reduce pain and inflammation.
In October, the FDA's department of pharmacovigilance published a review of injectable steroids that included records from its adverse events database. A summary of its findings was included in released in advance of this week's meeting.
The department's analysis found 131 cases of serious adverse neurological events including 41 cases of arachnoiditis -- a chronic pain condition involving inflammation of membranes surrounding spinal cord nerves -- after epidural injections.
Interestingly, the review found more adverse events using "particulate" steroids or suspensions, than "nonparticulates" steroids or solutions. "It is not known whether this difference reflects greater utilization of 'particulate' steroids or greater toxicity," the report noted.
The review also found "general consensus" that transforaminal injections into the opening of the spine where a nerve root exits were riskier than interlaminar or caudal injections.
To date, no large clinical studies have shown that one approach or formulation is safer than another.
After 2 days of discussion exploring the conditions treated, the location of injections, the injection approach, and the formulation of corticosteroids, committee members will offer recommendations regarding the need for further changes in class labeling.