An anti-inflammatory drug called Depo-Medrol which is manufactured by Pfizer has been approved for injection into muscles and joints.  Doctors have been Depo-Medrol shots for some time close to the spinal cord for painful backs, necks and conditions.  What few know is that Pfizer requested the Food and Drug Administration (FDA) to ban that type of treatment five years ago, stating in its request, “It must not be used by the intrathecal, epidural, intravenous or any other unspecified routes.”  The company is facing hundreds of complaints about injuries and complications related to the shots, yet the request was never made public by the FDA or Pfizer.The FDA decided not to approve this request, instead strengthening the label’s warning and use of the injections declined for some time.  However, now, the opioid epidemic appears to be causing its use to soar once against despite the risks.  In June, as part of legislation to address the crisis, the House of Representatives approved an increase in Medicare reimbursement for the procedure.  The number of Medicare beneficiaries receiving these injections is up 7.5 percent with a sharp 35 percent increase in sales.It’s a troubling trend to researchers and experts like Dr. Andrew Kolodny, co-director of opioid policy research at Brandeis University.  “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 Dr. Kolodny, who is also executive director of Physicians for Responsible Opioid Prescribing. “These are not benign procedures. Patients can be harmed and are harmed.”

Photo by Kinga Cichewicz on Unsplash

It is unusual for a drug company like Pfizer to request that one of its own products be banned.  Some physicians believe Pfizer is worried about liability from the off-label use.  The FDA’s new warning label indicates, “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.”  It warns that giving injections close to the spine can result in death.“The truth underlying it is that doing an injection is faster and results in higher reimbursements, compared to other ways of managing the same pain,” said Dr. James P. Rathmell, chairman of anesthesiology, perioperative and pain medicine at Brigham and Women’s Hospital.  “The use of injections has increased dramatically, yet the prevalence of back pain has remained relatively unchanged.”FDA records show there were 2,442 serious problems reported from Depo-Medrol injections from 2004 through March 2018, including reports of 154 deaths.West Virginia based anesthesiologist Dr. Brian Yee said more general practice physicians are referring patients to his clinic for epidural steroid injections and he believes spinal injections are valuable if administered properly.  However, physicians need to be properly trained.  “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,” he said.

Sources:

After Doctors Cut Their Opioids, Patients Turn to a Risky Treatment for Back PainEpidural Steroid Injection Outcomes and Prior Opioid Use