An FDA advisory panel has called for a contraindication for certain injectable corticosteroid formulations for epidural use.
An FDA advisory panel voted recently 15 to 7 in favor of a contraindication for certain injectable corticosteroid formulations for use in the epidural space because of the risk of adverse neurological events, such as spinal cord infarction, paraplegia, quadriplegia, stroke, and death.
The FDA's Anesthetic and Analgesic Drug Products Advisory Committee said the risks of injections of corticosteroids in the neck outweigh the benefits, saying that certain injectable corticosteroid formulations classified as "particulate" should be contraindicated for use in epidural administration. These include betamethasone acetate, methylprednisolone acetate, triamcinolone acetonide, triamcinolone hexacetonide and the combination of betamethasone acetate and betamethasone sodium phosphate.
However, the panel said that pain doctors are already using neck injections much less frequently because of the higher risk. If the advisory committee would have ruled that all epidural corticosteroids should be contraindicated, it would mean that the risk of use – such as death – outweighs any possible benefits, according to the FDA. “These situations include the use of the drug in a subpopulation of patients that have a substantial risk of being harmed by the drug and for whom no potential benefit makes the risk acceptable,” the agency said in its briefing document provided to the committee.
The FDA asked for the panel’s input on the safety of epidural injections because five patients died after receiving injections in the artery instead of the epidural space.
Earlier this year, the FDA issued a drug safety communication announcing that all labeling for injectable corticosteroids must warn about the possibility of rare, serious events occurring after the injection into the spine’s epidural space. The “rare but serious adverse events” include loss of vision, stroke, paralysis, and death, the agency said in its April Safety Announcement.
More than one million Americans receive epidural steroid injections annually, the agency estimates. FDA began evaluating the issue of serious neurologic events form epidural corticosteroid injections in 2009, but the injections received more national attention in 2012, when a compounding pharmacy in Massachusetts distributed tainted steroid injections, killing dozens and sickening hundreds.
However, the FDA advisory committee did not consider the issue of contamination during its November meeting.