5 Things to Know About Epidural Steroid Injections

By Margaret Aranda, MD, Columnist

Some patients with neck and back pain report that their doctor requires them to get epidural steroid injections (ESI's) before they are prescribed opioid pain medication. Many do not realize that the procedure or any use of drugs for spinal injection is not FDA approved and is considered "off label."

Some patients benefit from ESI’s, while others gain no pain relief or suffer serious complications. In 2014, the FDA warned that injection of corticosteroids into the epidural space of the spine may result in rare but serious neurological events, including "loss of vision, stroke, paralysis, and death."  

A 2015 commentary by FDA scientists in The New England Journal of Medicine urged doctors to carefully select patients to identify those who might benefit from spinal injections and to minimize serious risks.

Probably the worst epidural steroid catastrophe was the 2012-13 outbreak of fungal meningitis, caused by contaminated steroids produced at the New England Compounding Center. As many as 13,000 patients nationwide were exposed to the fungus, mostly through epidural injection, resulting in 751 meningitis infections and at least 64 deaths.

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Let's take a step back to assess why epidural steroids may or may not be a good idea. The rationale behind the procedure comes from the anti-inflammatory effect of steroids on the nerves.

Chronic inflammation in nerves can lead to pain, numbness, and muscle weakness. Nerve injury causes microscopic changes in nerve anatomy, including tissue swelling or edema, an increase in fibrous tissue and, in the worst case, nerve death through something called Wallerian degeneration. In cases like traumatic brain injury or stroke, the nerve damage can be permanent.

There are now about 9 million epidural steroid injections performed annually in the U.S and the number of procedures appears to be growing.

During a standard epidural injection, the doctor may inject into the epidural space a contrast dye using x-ray guidance (fluoroscopy) to make sure the dye is going into the correct location.  Others may use a more blind approach, called the "loss of resistance" technique, with a syringe of air that injects itself into the epidural space as it enters. There is a "pop" when the needle penetrates the epidural space.

After the air or dye is injected and the needle located, a second syringe containing  the steroid is injected. Afterward, the patient is observed for signs of pain relief and complications.

Many studies show that about 50% of patients feel better. If there is no pain relief after one ESI, a second attempt is usually in order. If partial relief is exhibited, a series of three injections in two weeks may be performed.

There is controversy over the rate and frequency of epidurals for pain. Typically, a “cycle” of epidurals is done, but if there is no pain relief after two injections, some doctors recommend that a different treatment be used. Some patients report getting as many as two or three dozen epidurals in a single year.  Critics say that raises the risk of a misplaced needle causing “cumulative trauma” and serious complications such as adhesive arachnoiditis.

If you doctor recommends that you get an epidural steroid injection, here are five things you need to know:

1. Drugs Used: The two most common drugs for ESI are a local anesthetic (lidocaine or bupivacaine) and/or a corticosteroid (betamethasone, dexamethasone, hydrocortisone, methyl-prednisolone, triamcinolone). 

The local anesthetic offers immediate numbing and pain relief. It also verifies whether the injection was done in the right place and gives an idea of how the steroid may act to decrease inflammation. After the anesthetic wears off, the steroid kicks in for an effect that may last varying times, sometimes for a short period and sometimes forever.

Patients and doctors need to know whether there was immediate pain relief from the local anesthetic. The doctor should ask, "Does the pain feel better?" to assess the temporary anesthetic effect.

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If the answer is yes, then the steroid should provide more pain relief. If the answer is no, the steroid is much less likely to have any clinical effect. There is no indication to repeat the procedure if there is no decrease in pain. Doing so would unnecessarily expose a patient to serious complications or death.

2. Injection Sites: The most common injections are into the neck (cervical) and into the lower back (lumbar). Less commonly, epidural injections are placed into the upper back (thoracic) or to the bottom tip of the spine in the sacral area (caudal). The needle can go either straight into the middle of the spine (interlaminar), or enter from the left or right side (transforaminal). 

In general, the closer the injection is placed to the head, the greater the risk of serious complications if the needle accidentally hits a nerve or artery, an air bubble causes an embolism, or if the injection goes into the spinal fluid.

3. Minor complications: Adverse events can occur within minutes or up to 48 hours after an injection. Minor complications are generally not life-threatening and usually go away with little to no treatment.

Some patients get an "epidural headache" when the needle is inserted too far into the dura, causing a leak of cerebrospinal fluid. This is a stressful and painful headache, but it usually completely resolves. Other minor complications include facial flushing, fainting, hypertension (high blood pressure) and increased pain.

4. Serious complications: No one really knows the complication rate of epidural steroid injections, due to under-reporting by doctors and the lack of standard guidelines.

Normally, the steroid will flow into the epidural space above and below where it was injected, but it can also flow into unintended places like the subdural or intrathecal spaces, cranial nerves, brain stem, and lower midbrain.

For example, if the injection accidentally goes into the spinal fluid, the procedure becomes a spinal block, not an epidural block. This may lead to potentially life-threatening complications. If this happens during an injection to the neck, it can spread upward, toward the top of the head and into the brain, leading to serious complications. 

Severe complications from an injection can include arachnoiditis, allergic reactions, stroke, brain edema, cauda equina syndrome, seizures, vasculitis, blindness, and death.

5. Off-Label Use: The FDA places epidural steroids in the category of "off-label" use that falls within the practice of medicine and is not FDA-approved. The FDA requires all glucocorticoid steroid warning labels to state:

The safety and effectiveness of epidural administration of corticosteroids have not been established and corticosteroids are not approved for this use… serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids.”

The FDA website also warns patients to seek emergency medical attention if they experience any unusual symptoms, such as loss of vision or vision changes, tingling in the arms or legs, sudden weakness or numbness, dizziness, severe headache or seizures.

If you have concerns regarding the use of epidural steroid injections, talk to your doctor.

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Dr. Margaret Aranda is a Stanford and Keck USC alumni in anesthesiology and critical care. She has dysautonomia and postural orthostatic tachycardia syndrome (POTS) after a car accident left her with traumatic brain injuries that changed her path in life to patient advocacy.

Margaret is a board member of the Invisible Disabilities Association. She has authored six books, the most recent is The Rebel Patient: Fight for Your Diagnosis. You can follow Margaret’s expert social media advice on Twitter, Google +, Blogspot, Wordpress. and LinkedIn.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

FDA Won’t Change Warning Label for Steroid Injections

By Pat Anson, Editor

The U.S. Food and Drug Administration (FDA) has decided not to toughen its warning label on the use of epidural steroid injections – despite the risk of serious and sometimes fatal neurological problems caused by the procedure. The injections are commonly used to treat neck and back pain.

Last year, the FDA required all injectable glucocorticoid products to carry labels warning that “serious neurologic events, some resulting in death, have been reported with epidural injection” and that the “safety and effectiveness of epidural administration of corticosteroids have not been established.”

Since then, the agency has been lobbied by interventional pain physicians who perform the injections to weaken the warning label; while patient activists wanted even tougher language used. The FDA will do neither.

“The FDA has decided not to modify the warning about serious neurologic events. Without question, serious (sometimes fatal) neurologic events occur with epidural glucocorticoid injection. Given the large number of these procedures performed, these events appear to be rare; however, a population-based study would be needed to establish a valid estimate of their frequency,” wrote several FDA scientists in an article published in the New England Journal of Medicine.

The use of steroids in epidural injections (ESI’s) has never been approved by the FDA, but millions of the procedures are performed every year by doctors who use steroids “off label” – which the agency considers “part of the practice of medicine and not regulated by FDA.” 

As Pain News Network has reported, ESI’s can be a lucrative procedure for physicians, depending on insurance payments and where the epidurals are performed. Payments can vary widely, from a few hundred dollars to over $2,000 per injection.

Critics say the injections are risky, overused, and often a waste of money. While side effects appear to be rare, they can be very serious, including loss of vision, stroke, paralysis and a disabling condition known as arachnoiditis, a painful and chronic inflammation of the spinal cord.

“What do you think would happen if the FDA were to contraindicate Depo-Medrol, the steroid that gave me adhesive arachnoiditis?” asked Gary Snook, a Montana man who developed arachnoiditis after a series of epidurals for back pain.

“In a few days we would be seeing TV commercials asking, ‘Have you received an epidural steroid injection? Do you now have burning pain in your legs? Do you now have numbness, tingling or weakness?' The phones would be ringing off the hook!’” said Snook in an email to PNN. “Because of the sheer number of injections given, even at a disability rate of 1%, every pain clinic and hospital in the country would be facing multiple lawsuits. No. The FDA had to do nothing. They had to keep a lid on this degree of medical malpractice.”

Depo-Medrol is a steroid made by Pfizer that has been banned for epidural use in Australia and New Zealand. Another steroid commonly used in ESI's, Bristol-Myers Squibb's Kenalog, does come with a warning label against epidural use, but patients are rarely told by their doctors about the risks involved.

“Sadly, in the current marketplace that packages and merchandises epidural injections for the short term address of chronic pain, (the FDA’s) decision makes it more difficult to obtain a true patient centered solution focused on the problem of preventing and treating chronic and intractable pain,” said Terri Lewis, PhD, a patient advocate. “FDA turned the keys to the asylum over to the corporations who lobbied hard to preserve their bricks and mortar investments supported by Medicare, worker's compensation, Medicaid, and private insurance.”

But the epidural injection industry didn’t get what it wanted, either. In a recent letter to the American Society of Interventional Pain Physicians, which petitioned the FDA to weaken or withdraw its warning label, FDA director Janet Woodcock said the label would not change.

“FDA has identified case reports of serious neurologic adverse events associated with all ESI approaches and all injection sites,” Woodcock wrote. “The totality of the available information provides evidence adequate to support the class safety warning.”

Woodcock also denied suggestions in the petition that an FDA advisory committee known as the "Working Group" met improperly with the Multisociety Pain Workgroup (MPW), a rival coalition of anesthesiologists, surgeons and pain management doctors, to discuss safety guidelines for ESI's.

"We do not agree with the unsupported characterizations of the Working Group, its activities, or its relationship to the MPW as asserted in your Petition," Woodock wrote.

Although 17 clinical guidelines were later issued by the Working Group, Woodock said the recommendations were for the "medical community" and were "neither binding on FDA nor endorsed by the FDA."

A federal study released earlier this year said there was little evidence that epidural steroid injections were effective in treating low back pain. The MPW called the report’s conclusions "flawed" and "absurd."