Capolongo’s group, the EDNC, wants the Food and Drug Administration to limit – or even ban – epidural steroid injections. The FDA convened a group to study the safety of some types of epidural steroid injections in 2009, but has made no announcements about its findings.
Since epidural steroid injections are not an FDA-approved procedure, The Dr. Oz Show asked the agency what authority it has to review their safety. “FDA regulates the drugs in question,” said a spokesperson, “and has the authority to review safety issues that arise for regulated drugs, regardless of whether the drug is being used in accordance with its approved use.”
A Long History
Since spinal injections for back pain are so popular, why don’t the steroid makers apply for FDA approval for that use? Actually, one did. Depo-Medrol, made by The Upjohn Company, was the pioneering steroid of its time. Way back in 1963, Upjohn applied for FDA approval to inject Depo-Medrol inside people’s spinal cords, called “intrathecal” use – deeper in the spine than an epidural injection.
But while Upjohn was waiting to hear back, doctors began experimenting with that use – and had devastating results. They found that steroids injected all the way inside the spinal cord could lead to a little-known condition called arachnoiditis, a condition that can be caused by any spinal procedure, including epidurals for childbirth. In arachnoiditis, the smooth, free-flowing fibers of the spinal cord wither and clump causing excruciating pain that arachnoiditis patients often refer to as “the pain of cancer without the release of death.”
Upjohn withdrew its application for intrathecal use of Depo-Medrol in 1969. Warnings against intrathecal use appeared instead. Those warnings evolved and here’s how the the package insert reads today: “Depo-Medrol is contraindicated for intrathecal administration. This formulation ... has been associated with reports of severe medical events when administered by this route.” The FDA told us that when a drug is contraindicated, that is “a strong recommendation by the FDA against the use of a drug because of the drug's potential risks or its potential to cause harm to a patient.”
But the idea of using steroids to calm spinal inflammation lived on. In 1982, Upjohn applied to the Australian government for approval to inject Depo-Medrol just outside people’s spinal cords, instead of inside. That’s what’s known as epidural use, the kind of injection done today.
In 1983, the Australian government recommended against approval, saying, “... Epidural administration of Depo-Medrol for the relief of spinal pain should be rejected, as the submitted data did not support such use, which may be associated with serious problems.”