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As physicians turn away from opioids, are they resorting to options that may also be unsafe?
The New York Times reports that some physicians are using the anti-inflammatory drug, Depo-Medrol, for intraspinal injections to manage painful spinal and perispinal disorders.
Five years ago the Food and Drug Administration was requested by the manufacturer Pfizer to ban the use of depomedrol injections owing to reports of blindness, stroke, paralysis and death. Pfizer offered that Depomedrol “...must not be used by the intrathecal, epidural, intravenous or any other unspecified routes.”
After an internal review, the FDA declined to issue a ban but toughened the label warning. Other countries (Australia, Brazil, Canada, France, Italy, New Zealand and Switzerland) have followed these same warnings.
In the face of a worrisome opioid epidemice there are concerns about the growing off-label use of spinal injections to manage spinal pain. The NYT reports that "weekend classes to train physicians in the procedure are flourishing" and that they are "transforming pain clinics into drill mills.”
Adding to the problem, the House of Representatives approved an increase in Medicare reimbursement for the procedure.
The number of Medicare providers giving steroid injections along the spine, including Depo-Medrol and other similar drugs, had increased 13 percent in 2016 from 2012. The number of Medicare beneficiaries receiving these injections is up 7.5 percent. The Department of Veterans Affairs reported a 17 percent increase in the injections from 2015 to 2017. Moreover, total sales of Depo-Medrol grew 35 percent to $185 million from $133 million from 2015 to 2017.
Pain specialists show claim that the pressure to avoid opioids is prompting many doctors to refer patients to pain intervention specialists who promote the shots. The temptation is that these injections are easier to administer and result in higher reimbursements, compared to other pain management alternative.
A freedom of information act review of FDA records on Depomedrol between 2004 - 2016 shows 2,442 serious problems, including reports of 154 deaths.
Pfizer notes that the product’s warning label states: “Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids. Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke.”
Pfizer says it is unable to track how much off-label Depo-Medrol is used, nor can it stop the off-label shots.