An injectable drug that Pfizer, its maker, claims is too dangerous to use along the spine is becoming more popular for patients with back pain as physicians turn away from prescribing opioids, The New York Times reports.
Five things to know:
1. The drug, an anti-inflammatory called Depo-Medrol, is approved for injection into muscles and joints. Although physicians have long given Depo-Medrol shots near the spinal cord for back pain and spinal stenosis, not many of them know Pfizer asked the FDA to ban that treatment five years ago after receiving hundreds of reports of injuries and complications. The company cited risk of blindness, stroke, paralysis and death being linked to the drug, but neither the agency nor Pfizer publicized this request.
The FDA did not issue a ban but strengthened Depo-Medrol's label warning. Other countries — including Australia, Brazil, Canada, France and Italy — heeded Pfizer's request.
2. Although use of the injections declined after concerns surfaced, the opioid crisis seems to be increasing the treatment's popularity. The number of Medicare providers giving steroid injections along the spine, such as Depo-Medrol, increased 13 percent in 2016 from 2012, and Medicare beneficiaries getting these injections rose 7.5 percent, the Times reports.
3. "The victims of our era of aggressive opioid prescribing are being exploited in some cases by interventional pain doctors, who will continue them on opioids in exchange for allowing them to perform expensive procedures that they don't need," said Andrew Kolodny, MD, co-director of opioid policy research at Brandeis University in Waltham, Mass. "These are not benign procedures. Patients can be harmed and are harmed."
4. A review of FDA records revealed 2,442 serious problems reported from Depo-Medrol injections from 2004 through March 2018, including reports of 154 deaths.
Pfizer did not comment on the deaths, referencing the product's warning label: "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."
5. West Virginia anesthesiologist Brian Yee, DO, told the Times more general practice physicians are referring patients to his clinic for epidural steroid injections and spinal cord stimulation than they have previously.
"With people trying to take away opioids now, we are opening up another doorway for people to overutilize other options that can be helpful with the right doctors and the right patients," Dr. Yee said.