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."

My Life with Arachnoiditis

By Tom Bresnahan

Let me tell you briefly about my past before I describe the hell I live with every day.

Before moving to Florida in 2000, I owned and operated a 6 store Domino's Pizza franchise in Tacoma, Washington. I served as an elected fire commissioner, belonged to two search and rescue groups, and was trained and certified as a swift water rescue technician. As you can see, I'm no couch potato.

tom bresnahan

tom bresnahan

After selling my business and moving to Florida I decided to pursue a career in healthcare, something I had wanted to do for many years. I went back to school and received a degree in Radiological Technology.

While attending school I fell off of a roof, damaged my back, and required surgery. In 2003, I had a triple fusion of my lumbar region performed by a local orthopedic surgeon. Everything went well and I went on to work as cardiac catheter technician, a fast paced, adrenaline junkie’s dream job! I took a lot of calls and enjoyed the challenge of working with a team trying to save the life of someone having a heart attack. 

In 2009, I started to have sciatica pain in my right leg. It was interfering with my work, so I went back to the doctor who had performed my surgery. He suggested a series of epidural steroid injections. He said they were extremely safe and could eliminate my pain.

When I arrived for my first injection, I reminded the nurse to tell the doctor of the “outpouching” I had on my spinal cord. This is known as a pseudomeningoceale. It was caused when the doctor doing my first back surgery performed a laminectomy and didn't take the right steps to keep the pouch from forming. When I discovered this on an MRI and asked him about it, I was told that it was completely normal and that I shouldn't be concerned. 

The image on the right shows the pouch as a white mass on my spine.

The first steroid injection had no effect, so a few months later I went in for a second. Again I reminded the nurse about the outpouching. This message was never shared with the doctor, although he should have looked at my chart prior to the procedure.  The injection was given and within hours my pain became elevated. I called the doctor and was told this is normal and not to be concerned.

Over the next several days my pain increased, and it was difficult to concentrate and perform my job. I was seen again by the doctor and he scheduled a discogram, a test is to see if a disk is ruptured or torn. It is a very painful test. The results came back stating I had a torn disk above the level of my first surgery. The doctor said I would need another fusion. 

I went in for surgery on September 8, 2009. By then the pain was quite bad and I was looking for anything to give me some relief. After I was partially sedated the doctor came in and told my wife that this surgery would most likely not help with my pain. I was nearly out and she didn't know what to do, so in I went for what would be a totally unnecessary procedure. 

As the pain medication from surgery wore off, the pain was so bad it made me scream out loud. This went on for months! My wife took me to the ER and back to the doctor’s office, where I was told, “We don't know what’s wrong." 

I couldn't work and after being out for 90 days I was terminated. I was devastated that I was losing a job I loved and spending every moment in horrific pain.  I finally went to see a neurosurgeon who ordered a myelogram, an image of my spine that was performed at the hospital where I had worked.

The neurosuregon, who I had worked with on several occasions, did the test. Afterward he came into the recovery room and said, "Tom, you're screwed!" 

I laughed thinking he was joking. 

“You have a condition known as Adhesive Arachnoiditis,” the doctor told me. “You're going to be in pain the rest of your life!" 

I was shocked and couldn't believe this was happening. He told me the nerves within my spine were all clumped together. He said over time scar tissue would form and probably make the pain worse and cause things like bladder and bowel dysfunction. And there was no cure.

The test was done and I learned my fate on Dec 31, 2009. Happy New Year!   

Over the next few months I went through many medications, trying to get the pain under control. The drugs did very little to help. I also ordered copies of the dictations from all of the procedures I had done by my surgeon. On the dictation done for my last injection the surgeon stated, "I did get withdrawal so I repositioned the needle and did 4 injections.” 

The "withdrawal" was spinal fluid. He had punctured my spinal cord, yet continued to inject the steroid Depo-Medrol into my spine. When I confronted him at what was to be my last appointment, he told me, "You would have a hard time proving it!" 

Since that time I've been through the 5 stages of grief, with anger being the hardest to overcome.  I was determined to find a fix, but eventually realized there was none. 

I came close to ending my life on two occasions. My wife of 3 years told me, "I didn't sign up for this!" We divorced shortly after that. 

I have spent the last 2 years trying to effect a change and educating people on the dangers of epidural steroid injections. I have tried to help others with Arachnoiditis find medications, support and the faith to continue on each day.

I have a phrase that I tell those who feel the desire to end their pain and their life, "As long as we are breathing there is hope!" 

The pain has gotten worse over the last 2 years. I have had episodes of not being able to move my legs when I wake up in the morning. This alone will scare a person terribly! My legs go numb if I sit for more than 15 minutes.  The pain now extends into my arms and hands. 

Because this condition affects the nervous system I have developed an internal thermostat problem. I will feel cold and actually shiver in a room that is 76 degrees. At other times I will break into a sweat that's so bad I'm drenched within a few minutes, to the point that I have to change shirts. I can't tell you how many times I've lain in bed screaming because the pain is so bad. 

I have never in my life been one to take it easy, yet I've had people actually tell me, "It couldn't be that bad!" 

This is demoralizing, frustrating and depressing. Steroid injections are a band aid at best and the destroyer of life at worst. Please help us put a stop to these injections that are causing so many to suffer so much!

I want to thank you for taking the time to read my story. I pray every night that if we can stop anyone else from ending up with this hellish pain then I will feel that I have made a difference. 

Tom Bresnahan lives in Florida. He is a patient advocate and activist with the Arachnoiditis Society for Awareness and Prevention.

Pain News Network invites other readers to share their stories with us. 

Send them to:  editor@PainNewsNetwork.org.

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.