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Epidural Corticosteroid Injections May Cause Neurological Damage: FDA

New warnings issued by federal drug regulators suggest that side effects of epidural corticosteroid injections may cause severe injury or even death.  

On April 23, the FDA issued a drug safety communication, alerting the medical community and patients about the risk of rare, but serious, neurological problems that can occur after receiving injections of corticosteroids into the epidural space of the spine. The agency says it will require new label warnings for all such injections.

The FDA began reviewing the safety of the injections after medical professionals raised concerns, reporting serious events that have included death, spinal cord infarction, full and partial paralysis, blindness, strokes, seizures, nerve injuries and brain edema.

The agency says that while many patients recovered within minutes to 48 hours after the injections, many patients have never recovered from the epidural steroid injection problems.

Epidural corticosteroid injections are used in the pain management industry to treat neck and back pain, but the FDA has never approved them for that purpose. The agency also warns that they are not proven safe or effective in treating pain.

In a study published in the medical journal Spine in March 2013, researchers found that patients given epidural steroid injections received little if any benefit and in many cases fared worse than those not given the injections.

In their conclusion, the researchers theorize that the additional volume added to the body by the fluid in the injection may actually exacerbate the pinched nerve and cause more pain after the short-term pain relieve is gone. The shots may also cause long-term damage to the nerve roots, which the FDA appears to confirm with its latest warning.

The FDA warned doctors that the neurological damage from epidural injections have been reported with and without the use of fluoroscopy, urging doctors to discuss the risks with patients before prescribing the injections. The agency also urged doctors to tell patients to seek immediate emergency treatment if they experience symptoms of epidural steroid injection complications, including vision loss, tingling in limbs, sudden weakness or numbness, dizziness, severe headache, or seizures.

While it is illegal for drug manufacturers to promote corticosteroids, or any drug, for uses not approved by the FDA, doctors are allowed to prescribe drugs for any purpose they see fit. The agency says it will seek to raise awareness of the risks of the injections through its Safe Use Initiative.

A panel of experts was convened on the issue to look at techniques for using the injections more safely. The FDA says it will release the recommendations once they have been finalized.

Warning Follows Deadly Meningitis Outbreak

Corticosteroids used off-label for pain injections include methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone. They are generally used to reduce inflammation and swelling.

Methylprednisolone was the steroid used in thousands of recalled epidural steroid injections that led to a nationwide fungal meningitis outbreak in 2012 and 2013.

The outbreak sickened more than 700 patients and killed more than 60. It was traced back to back pain injections distributed by the New England Compounding Center (NECC) to hospitals and pain management centers nationwide.

The U.S. Centers for Disease Control and Prevention estimates about 14,000 patients in the U.S. were exposed to the tainted shots, which in some case had visible particles of fungus in them.

After an epidural steroid injection recall in October 2012, which later expanded to all of drugs compounded by NECC, the pharmacy was forced to cease operations and its compounding license was revoked.

NECC was eventually driven into bankruptcy under the weight of litigation and fines faced, and the incident resulted in new regulations for compounding pharmacies nationwide.

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18 comments

  1. Susan Reply

    I am about to begin a series of epidural shots to help relieve sciatic and back pain. Am I taking a real risk in doing so?

  2. Misty Reply

    Susan, i also had these injections to help sciatica and back pain. They didnt help one bit. And i have gotten worse over the years of having anything done to me. I had these injections before and after i haf a spinal fusion to try and get pain relief. Its a waete of time energy and money. Just another way for a dr to make money off of us. I guess they help some people but my pain is God awful!! I dont wish this pain upon anyone. Please do research on the people its helped verus people it hasnt helped. My migraines are out of control also. I will be researching if theseay have been the cause of them getting worse. Cause no medication is helping them either. I have a migraine right now as i type this also. Just please research some more..if you would like to talk more you can find me on facebook. Misty Tom Lawrence.

  3. Bianca Reply

    I had an epidural steroid injection under fluoroscopy in nov 2013 that went wrong instantly while one the table. Doc claimed what I felt was normal. With being injected with a local, I believed I shouldn’t have felt any of what I was feeling. Everything went down hill from that moment to evening and days following to today May 27th, 2014 as I am now diagnosed with intracranial Hypertension an incurable condition with limited treatments involving medications with horrible side effects and surgical procedures including serial spinal taps, optic nerve sheath fenestration and brain shunts which I am trying to avoid as they are very controversial and risky also.
    None of which I was warned about as I was told this is an ordinary procedure that people get everyday and go home right afterwards.
    It seems the culprit was the infamous “Kenalog”.
    My advice…. Steer clear and use all your will power to build your muscles and heal your body naturally any way you can without injecting this poison into your body!!!! Do not risk this nightmare I am living right now. You can pretty much say goodbye to everything you are used to because everything will turn upside down too fast.

    My adventurous 36 yr old life with my 9 yr old son had come to a scratching halt as I knew it at a young age.
    There is no other way to explain this other than a “Nightmare”!

  4. Gary Reply

    Susan,

    Your doctor is putting you at extreme risk for developing a rare and incredibly painful condition caused adhesive arachnoiditis. These injections benefit no one but the doctors pocket book. Ask your doctor for a medical study that proves they work? There are none and what is more if you develope adhesive arachnoiditis your pain will be 1000 times worse than it is right now and this disease is hoplessly incurable Watch this video of information presented dy Dawn Fickle about what happened to her brother at a recent FDA hearing on the safety of ESI’s and learn what the doctor isn’t telling you can happen:

    https://www.youtube.com/watch?v=f39R_HSfyt4

  5. krys Reply

    Bianca- I’ve had 2 lumbar epidurals of kenalog 80 and one cervial epidural 80 mg and have had no diagnosis after a year still. Only guesses of mini strokes and silent migraines. I have passed out multiple times, I have the blood rushing behind my ears and the dizziness and major fatigue along with the extremely stiff neck and pains in my limps and numbness. After looking up the Inter cranial Hypertension I believe I also have this. What kind of doctor did you go to for the diagnosis? I was lied to about what they injected me with and now I am in the middle of a major medical malpractice law suit and I just need to get a diagnosis. Most of the doctors toss me to the side because they either give Kenalog shots or they have no knowledge of the effects of it. Most have told me there is no way possible it can affect you neurologically…which obviously isn’t true as it states it right on the bottle that it causes major sensory disturbances and other major neurological problems. Please let me know how you are doing and what kind of doctor you had to go to for a diagnosis. Thanks

  6. Faith Reply

    i have gotten epideral injections the last 4 years. They do work for me. Last year I just had one injection. And it got my pain manageable. This year 2 of them. I got the caudal as my leg and foot have nerve Damage. My foot starts to feeling like its burning. And shooting pain down my leg. It has helped be out a lot.

  7. Tara Reply

    I had a cervical epidural done January 28th, 2015. I was put to sleep for the procedure and when woken up to switch from the OR table to my bed. I realized I lost my whole upper left side. I asked the nurses, “where is my arm? What happen to my arm?” I know they all thought I was crazy. In recovery I couldn’t feel my left side. I was kept for 4 hours for observation. To this day I am still partially paralyzed and have lost the full use if my hand and fingers. I know suffer from muscle atrophy in arm and hand. I have a disterbance of skin sensation. I can’t feel temperatures and extreme heat and cold make my arm burn tremendously. I can’t handle my arm being touched. Even the touch of clothing or a blanket causes me a great deal of pain. However I feel this horrible pain, yet I have no feeling. I had an MRI done that shows lesions in my spinal cord where the needle placement was. I’ve had an EMG and nerve conduction test that shows spinal cord nerve damage. I firmly believe the needle came in contact with my spinal cord and caused damage. It’s been an awful year dealing with this. I had 4 lunar epidurals, and 2 sciatic nerve epidurals all with great success. This cervical epidural has ruined my life and we’ll being. I wish I NEVER had it done.

  8. lena marie Reply

    my mother had take the epidural in 1974 and there was defect in that give her child cancer

  9. lena marie Reply

    my mother had take the epidural in 1974 and there was defect in that give her child cancer

  10. Sharon Reply

    Had epidural of kenalog it switched my sympathic nervous system on 24/7 I did not sleep my body was full weak and full of fluid. My legs were like cardboard terrible pains in my whole body. I couldn’t rest or relax sleep as I was in fight and flight with my nervous system. Ever think kept going down hill till eight months after I had it my health was destroyed. The effect of my nervous system being constantly on the go and the adverse effects of the drug destroyed my digestion bowels my muscles tendons and left me housebound with chronic health problems. I can’t eat a healthy diet or get much sleep my health has suffered badly. I can’t look after my health it just completely destroyed me. My life is over due to this drug and there is no justice for my life ruined.

  11. Nita Reply

    I wrote on when a lumbar epidural goes wrong causes so much pain in the lower back and numbness and tingling down my right leg can’t walk walk like your are in your 80’s this happen to me when I had my daughter in 2003 and the doctor told me it didn’t come from the lumbar epidural injection shots.Since then I been getting steroid injection in my lower back only last for 2 hours stop letting them put in my back let them out it in my left arm having trouble with my left arm now.I so glad people are speaking out.I have talk to the doctor who gave me this epidural shot he it never happened to him for someone that the epidural causes problem

  12. Tony Reply

    I wish I would’ve knew about the studies prior to having my epidural injections. I got an infection and had 9 inches of my spine removed and replaced with a donor humorous bone and spent the last 12 years of my life with back pain I know I’m permanently disabled

  13. Fred Reply

    I am in the same boat as Sharon. I was at one time a teacher and coach. Then on May 9th 2014, my life has since changed as my sympathetic nervous system was “turned on” by a cervical epidural. To describe the way you feel is to describe the indescribable. Constant lightheadedness, diziness and the feeling of passing out to name a few things. The worst part is the anxiery caused by a sympathetic nervous system out of control. It is not anxiety in your head it is caused by a nervous system gone haywire. Dr. visit after Dr. visit has been a joke. Most listen and say you need counseling. I implore anyone thinking of getting a cervical epidural or any epidural to please consider not doing it. My pain was nothing compaired to this form of torture. I have lost my ability to work, many friends, and so many things I took for granted. I sit at home hoping one day I can get the old me back. Please exaust every option before getting an epidural steroid injection.

  14. Reuel Reply

    I was given 2 lumbar cortisone shots with depo medrol 2 weeks apart in late 2013. After the first shot, I felt like my spine was going to explode, I felt so much pressure from the inside my spine, I was in atrocious pain, then my whole left leg started numbing and hurting , I couldn’t move my left leg completely for about couple of hours that day, that’s when I called the pain management clinic and informed them of what was going on, paralysis like I felt it is a nightmare I swear. I told the clinic that I wanted to forego the next injection which was due 2 weeks later, they asked me to still come in and tell the doctors about the side effects and so 2 weeks later I went in and by that time I started walking with a cane, I told the doctor that I was having complications and I didn’t want to proceed with the injection i asked him instead about another procedure which I had read about the night before which consisted of killing the nerve and I remember this as if it was yesterday, it was not the same doctor from the time before, this new doctor told me that the first doctor had gone in my back straight and that he may have hit a nerve and that he would go in from the side which had a bigger opening between the vertebrae and that it would “reverse” the side effects that I was having I showed reluctance and he left me in the office, he was a little frustrated. The nurse came in afterwards with paperwork for Mr to sign, again I reiterated my anxiety, she told me that she herself had gone through back surgery and that if this procedure happened not to work I could try her back doctor some neurologist to whom she gave me the contact on a piece of paper which I still have. Needless to say when I was being taken to the surgery room I felt scared and out of options, the doctor may have felt slightly offended by my reluctance so after the procedure he just walked out, i wasn’t offered a wheelchair ride to my car just as they did the first time around, I was hurting but slowly made my way to my car, 2 weeks or less later I ended up in the ER at the VA hospital from chronic back pain, I am a veteran of the US army and because I felt like the pain clinic mishandled me and caused greater damage I settled to only go to the VA hospital, after over 2 years of conservative treatment (therapy and testing ) my condition has worsened, a month after my last cortisone shot I developed a swelling in my left ankle which they defined to be edema, after I asked for a sonogram I clearly noticed on the monitors that the texture of the muscle right by my ankle looked very contrasted from my right foot and the technicians noticed it too, to my surprise when the test was sent to my doctor he recommended I take some ibuprofen and put my ankle on ice, it was a little disconcerting bit I followed his advice by that time I was on medication like gabapentin, cyclobenzaprine etc, I did several rounds of therapy and surgery had been considered at one point but now the doctors are saying that they can’t help no more, in the meantime while I was doing therapy my therapist noticed that my left foot was unusually cold, she freaked out and sent me to my primary doctor who ordered a vascular lab that came back negative, I am on a daily antihistamine regiment because my skin swells and bumps up and I start itching until I draw blood it is very painful to say the least. I can really stand on one leg, my right one which is starting to give out, i have almost constant involuntary muscle twitching (even as I post this) visible with the naked eye, my left occasionally swells up on top of the edema that is always there, my doctors have mentioned possible complications from the lumbar cortisone injections but nothing definitive, I am in constant pain and the prognosis for me is that I will end up in a wheelchair, I am devastated, I was working when my accident happened that led me to do those shots after regular therapy failed, I have not worked since, I was given a permanent disability status by my doctors I am pretty much alone in this, never settle for these shots, this is my story

  15. Deborah Reply

    I am damaged permanently from these shots. I couldn’t walk after I had my first injection and after the 48hrs I fell around everywhere losing my balance etc. They continued the series even after they knew I was having problems. I have permanent weakness to my right side of my body extensive walking causes more weakness and excruciating pain in leg and back. Months later I got bells palsy in my face which caused permanent facial paralysis on my right side. The injections were done in 2008. I struggle daily walking and I have seizures weekly and my life has been torn apart. I will tell anyone never ever get these shots no matter what anyone tells you. I was on workers comp from a work injury when I got them. I can’t work anymore and am in a wheelchair for long distances and walk with a cane all other times because my right leg gives way. I was 28 when this happened I’m now 39. It ruined my life and my families life. I’ve been everywhere and no one can tell me what happened other than I have weakness to right side of body and neurological deficits along with all types of seizures. I’ve not been the same since that first shot. Please never get them you take a chance. When I had this done there wasn’t any warnings there wasn’t anyone on the internet that had similar problems from the procedure. There was just info saying it was safe and very few if any side effects were known.

  16. Susan Reply

    Krys,
    I also had two Kenalog 80 mg injections. The first one went fine. The second one did not go well. The following day I had severe swelling in my hands and everything is gone downhill since. my joints hurt my memory is not what it used to be, I have ,problems thinking of words I want to say, tremors. I have looked up Kenalog 80 mg trying to find severe side effects and have found some things. A spine surgeon has potentially diagnosed me with RSD. I believe the injection injured a nerve root but I’m having issues finding a doctor to do testing. The Kenalog also put me into menopause. Unbeknownst to me, I went through it in six months. I only found out because I went to my primary care physician because I was not feeling right six months after the second injection and had her do intensive blood work.
    If you have found any more information please let me know. Good luck.
    Susan

  17. Pooky Reply

    I have had many injections with multiple pain medications for several years after an injury. Most Patients with Back Pain have Injuries! I developed Ulcers, Severe Constipation, IBS-Mixed, chronic dizziness, LiverBladderGallbladderSexual & Abdominal Dysfunction, Bacteria infections, Loss of Vision, Destention, Bloating, Weakness, Nerve Pain and other symptoms. Any side effects & allergies are often ignored by doctors & diagnosed as IBS or Anxiety. I was then given several epidural injections at one time. My sciatica nerve pain increased & I got worse! Doctors will immediately diagnosis something else, like fibromyalgia! Doctors don’t want to deal with cases of Workers Comp, Disability, or Any Legal matters. So they will purposely avoid this by misdiagnosis. Long Term Injections & Long-term pain medications may cause bacteria infections, gallbladder problems, appendicitis, leaky gut, high blood pressure, liver dysfunction, vascular problems, urine retention, Severe weakness, worsening degenerative disease, arthritis, nerve damage, Ulcers. Not one doctor explained to me these risks. They are a big money $ maker for healthcare. My advice is that if you get these injections, please know that it may relieve pain for a short time, or you could get worse. My chronic symptoms may be explained on my undiagnosed MRIs, but I got worse immediately after Epidural injections. They will NOT cure you! Any of these Injections or Narcotics Pain meds are only supposed to be used for Short Periods of time, not Long-Term. The longer you use these drugs, the more damage is likely. These drugs are to Cover up & Relieve Pain. They do NOT cure you ! Please look up drug side effects & interactions! Our Healthcare is Not Monitoring these drug interactions or Side Effects. Doctors don’t want to be bothered with legal paper work, so they Will MISDIAGNOSIS you to avoid it! MISDIAGNOSIS & DRUG REACTIONS are KILLING patients in higher incidents today! Often these drugs are used for pain without even finding the TRUE CAUSE of the pain! Epidural injections are Not FDA approved. They cause NERVE DAMAGE more often then is reported because Doctors fail to report most side effects. Doctors will also cover for Other Doctor’s errorrs. Doctors should find CAUSES & CURES and hire an assistant to deal with paper work so doctors can diagnosis patients appropriately. Use these drugs with CAUTION & SHORT TERM only!

  18. Steven Reply

    I was referred to Dr.Alfred j Beshai by spine specialist Dr.Alan Crowder after he informed me that I wouldn’t benefit from surgery and that I would be in pain for life due to muscles over compensating for deteriorated disc and was examined by Dr.Beshai who wanted me to have ESI injections and I told him I didn’t want more injections I had already had multiple inlections and the last three had not helped he then said that I needed another MRI but because I was uninsured and was dependant on Charity Care that they wouldn’t pay for it unless I had three more injections, I was not offered another treatment option and had been without any meds or ability to work since 2012 and denied SSDI benefits and was married my wife also disabled and we had three children in our care I agreed since I had no way of avoiding the continued agony I had been trying to cope with.I underwent the first on January 8, 2015 at Carilion Community Hospital and during the proceedure I was injured and experinced intense pain during the needle placement and was ask if wanted to stop the procedure and told me I could go back to Roanoke Memorial where I had had the last several injections but I told him I needed relief that I couldn’t endure another 3 month period in agony with nothingvfor pain he finally finished the procedure and told me that something was wrong that it should not have been so painful that if I desired more injections that I would be put to sleep.I was released and returned home where I began to have dramatic increase in my pain and my wife became concerned and called his office and he told her to tell me to go to the ER which was impossible I was unable to get up for several days afterward and soon began to develop severe headache and mental fog and later severe neck pain and I believe I had a stroke which caused me to have difficulty speaking clearly and trouble swallowing,I went to the free clinic after the speech and swallowing had subsided after a couple days and later the ER when my neck pain became unbearable and was unable to get the staff at the Carilion Franklin Memorial to believe me or test me for damage to my lumbar spine after informing them of a increase in my back pain and my fear of possible complications causing my new symptoms as prior to the ESI on January 8th I had never had any pain except in my lower back and I was referred to a neuro surgeon at Carilion who I saw and was tood that it was just a pulled muscle.I was later again seen and referred back by the ER and seen by another neuro surgeon who wanted me to have an ESI in my cervical spine which I refused and was only offered surgery for my neck which I declined .I have been unable to get spinal tap or investigation by anyone at Carilion and have since been developing sensitivities to a list of chemicals and mold and am without means to travel due to the severity of pain when I am in an auto and my hearing has began to ring and I can not tolerate noise and periodically light and I am forced to live on 72 dollars in spousal benefits and would not be alive if not for my wife and children who are now endanger due to mold in our home and I cannot access treatment other than Carilion or my current Dr at Tri Area who I believe is incompitant as I have had no luck in getting a referral to anyone to investigate my concerns and have had pancreatitis 4 times one of which I was arrested and removed from the ER at Carilion Franklin memorial after admission without ever having anyone legally capabile of assessing my stability for transport and without treatment where I upon reaching the Franklin County jail I informed the officers that I was going to sue them and I was told by one of them good luck then placed in a cell and released 5 or ten minutes later and charged with disorderly conduct and wheeled out in a wheelchair where my wife informed the police that we couldn’t go to another hospital and was told if I went back to Franklin memorial I would be rearrested and held for the night.I was forced to go home and suffer with pancreatitis till the next morning.I am lucky to be alive and my rights have been violated and I am now living in a tent and am certain that my death will result from the injury I sustained and have accessed the My Chart web portal at Carilion and discovered that Dr.Beshai made comments on my record about nerve damage.I believe my life is dependant on my getting treatment and I am unable to find protection of my rights or my life by the corrupt police in Franklin County VA if anyone reads this please help me get someone to atleast insure if I die that this miserable unnecessary injustice and negligence doen’t happen to someone else its hard for me to believe that the place I was taught to trust my life and health with and the cops who my tax money pays to protect have instead conspired to silence and cover up the abuse and possibally my future murder at the hands of Carilions care this is not the America I am proud to be part of and God will have no mercy for those responsible I have even contacted Senator Kaine’s office asking him to reopen my SSDI case and informed him that the vocational expert testified at my hearing that as of 2015 there were no jobs I could perform but I am afraid that he isnt going to help even though my family is being abused by the system and I can only pray .These injections are killing people and unfortunately they are the lucky ones as death would be better than living with out hope or protection before dying without justice.

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