FDA Warns About Dangers of Epidural Steroid Injections for Back Pain
The Food and Drug Administration has just issued what’s called a “Medwatch Alert” warning that Epidural steroid injections or “ESIs” for back and neck pain can be extremely dangerous. The alert says: “Injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death.”
Epidural steroid injections – and catastrophic injuries from them – were the subject of my debut investigation for The Dr. Oz Show almost exactly a year ago. (You can watch the video here and read the web article here.) The epidural space is an area between the spinal cord and the bony structure of the spine.
Our investigation revealed that the steroids – called corticosteroids – used for epidural injections are not even FDA approved for this purpose and yet ESIs are done nearly 9 million times a year, according to an analysis by Dr. Laxmaiah Manchikanti.
In addition to informing the public via its Medwatch Alert, the FDA said, “We are requiring the addition of a Warning to the drug labels of injectable corticosteroids to describe these risks.” Injectable corticosteroids include methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone.
The new warning will be a more prominent reminder to doctors that injecting steroids into the epidural space, just outside the spinal cord, has risks. But the warning failed to list all of the possible adverse reactions. Those reactions are named in the fine print of current drug labels, and include: “arachnoiditis, bowel/bladder dysfunction, headache, meningitis, parapareisis/paraplegia, seizures, sensory disturbances.”
In 2009, the FDA convened a group to study the safety of some types of epidural steroid injections. In its new notice, the FDA said that group’s recommendations still are not ready and will be released when they are.
Dennis Capolongo of the EDNC, a group that has been campaigning against epidural steroid injections for years, called the FDA’s new warning “bitter sweet” because it did not go further. Capolongo wants the FDA to go beyond telling doctors that injecting steroids into the epidural space COULD have severe side effects and instead state that they MUST NOT do it.
In February of this year, Australian and New Zealand health authorities came out with exactly that stronger language, stating that steroids like this, “MUST NOT be used by the intrathecal, epidural, intravenous or any other unspecified routes.” The South African government issued similar warnings, according to Capolongo.
Since the FDA is still actively studying these procedures, it will be interesting to see if the agency takes any further steps. If and when it does, you can bet I’ll pass the information along.