Ninety percent of us will suffer from low back pain at some point in our lives, according to statistics gathered by United Healthcare. And if you suffer from chronic pain, chances are you’ll be offered a procedure called an epidural steroid injection or “ESI.” It is also known as a “cortisone shot.” ESIs are placed in your spine like an epidural for childbirth, but use different drugs.
Epidural steroid injections have become the most common procedure doctors do for low back pain – done nearly 9 million times a year, according to an analysis of Medicare records by Dr. Laxmaiah Manchikanti. But here’s what most people are never told: ESIs are not FDA approved. And, yet, when Dr. Oz Show producers called more than 20 pain clinics, posing as patients, all but one insisted that epidural steroid injections are FDA approved. That’s wrong.
The steroids used in epidural steroid injections are FDA-approved for your muscles and joints, but the FDA has never approved the injections for spinal use. Doctors are allowed to use drugs for other purposes than those they were originally approved for -- this is called “off-label use” – but that means that use never underwent an official study to make sure it’s safe and effective. Even so, Medicare covers ESIs and insurance companies also pay for many of them.
Epidural steroid injections are promoted as a less invasive alternative to back surgery, but there are potential problems when doctors work so close to your spinal cord, even if they’re using needles instead of knives. It’s impossible to get a grip on the number of injuries and deaths due to ESIs because doctors are not required to report them. So the best hard evidence of catastrophic complications comes from isolated case reports rather than large-scale stats or studies.
Dennis Capolongo says he’s one of the injured. Capolongo was suffering from hip pain – not back pain – and says a doctor recommended an epidural steroid injection to treat it. He says that a 15- to 30-minute procedure turned into 3 days in the hospital, 3 years unable to walk without a cane or walker, and a lifetime of work as an anti-ESI activist. “It outrages me … how something like this… has become the standard of care,” he says.
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.”
Where Things Stand Today
Today, the Depo-Medrol package insert says inthrathecal use (inside the spinal cord) is contraindicated, but epidural use (outside the spinal cord) is not, even though further down, in the fine print of the insert, the possible “adverse reactions” listed are identical for both uses: “arachnoiditis, bowel/bladder dysfunction, headache, meningitis, parapareisis/paraplegia, seizures, sensory disturbances.”
Why the same side effects? Studies show that epidural injections, sometimes accidentally become intrathecal injections when doctors push the needle a little bit too deep. The margin of error is tiny, one membrane called the “dura,” that is only about as thick as a piece of tissue paper.
Pfizer bought Upjohn in 2003, and now owns the rights to Depo-Medrol. We asked Pfizer to comment on doctors’ off-label use of their drug for epidural injections. “Pfizer does not condone the off-label promotion of our products,” said a spokesperson. “We believe that our sales and marketing practices are solely based on our prescription information as approved by the US Food and Drug Administration."
Today, several different steroids, by different manufacturers, are used for epidural steroid injections. Another, called Kenalog, is made by Bristol-Meyers Squibb.
In June 2011, the company updated the package insert for Kenalog with a stronger warning that says, “Epidural and intrathecal administration of this product is not recommended” due to “reports of serious medical events, including death.”
When we asked Bristol-Meyers Squibb what prompted the change, the company said, “During post-marketing safety surveillance, adverse events related to epidural administration were identified. This prompted the company to submit revised safety language to the US Food and Drug Administration.” (Read Bristol-Meyers Squibb’s entire statement about Kenalog.)
In addition to arachnoiditis, other serious epidural steroid injection complications include meningitis, paralysis and death.
In 2012, more than 700 people contracted meningitis or other infections and 50 later died after doctors performed epidural steroid injections using steroids tainted with fungus. The medications were made at a company called New England Compounding Center, which mixed its own drugs. But meningitis had been reported as a possible ESI side effect long before those events, in patients who were injected with name brand drugs.
Paralysis is another documented risk. Paraplegia, where patients are unable to move from the waist down, is listed as a possible adverse event on some steroid package inserts. Other forms of paralysis are possible as well. In 2010, a jury awarded Kathleen Ramey of Florida $36 million, after her arm and hand were left paralyzed by an ESI. She has yet to collect a dime, though, because her doctor is in prison, after pleading guilty to illegally distributing narcotic painkillers.
Of course, the ultimate side effect is death. Some of the steroids used in epidural steroid injections have a gritty, granular makeup. If a doctor accidentally misfires the steroid solution into a patient’s artery, that can create a blockage, cause a stroke, and cause death.
Disclosing ESI Risks
In 2007, researchers sent surveys to all US physician members of the American Pain Society anonymously, for a study of upper spine ESIs published in the journal Spine: 27% knew of patients who’d had dangerous complications and 4% knew of patients who had died. The total number of complications was 78. Deaths numbered 13. By contrast, doctors who perform epidural steroid injections say publicly that catastrophic outcomes are rare.
The Dr. Oz Show went undercover to pain clinics to see if they were clearly disclosing the risks of epidural steroid injections. None of the clinics mentioned any risks until we asked. When we did inquire, nurses mostly mentioned low-impact side effects like facial flushing, headache and skin infection. One doctor said, “There’s always some risk but the risk is negligible. It’s minimal.” Another told us, “The risk is similar if you wanted to walk from here over to the McDonalds, and the likelihood you’re gonna get hit by a car that day.”
There will soon be clearer data about your risk of being harmed by an epidural steroid injection. Dr. Janna Friedly of the University of Washington is leading a team that is conducting a large-scale clinical trial to see just how risky ESIs are. Her team is also analyzing data from Medicare patients who received epidural steroid injections. Friedly told The Dr. Oz Show, “The risks are higher than we thought.” Friedly said the risk rises when ESIs are performed by poorly trained doctors.
Dr. Paul Lynch, an Arizona pain doctor, also appeared on the show. Lynch said he has performed more than 5,000 epidural steroid injections without any adverse patient outcomes. He said even his mother has even gotten the injections. Lynch said the key is for doctors to thoroughly educate their patients about the possible risks and possible benefits of ESIs. Lynch said ESIs can give patients short term pain relief so they can get started on a physical therapy program. He said the real problems in pain management are unnecessary back surgery and addictive pain medications. Read Dr. Lynch’s statement.
ESI Use Growing Fast
The number of epidural steroid injections performed has surged, rising 271% from 1994 to 2001 according to an analysis of Medicare claims. Why would doctors risk your health and their careers on a procedure that carries significant possible risks? Critics say they do it for the money.
Dr. Friedly’s soon-to-be-published study will show that doctors can make as much as $2,000 for an ESI, which is only a 15- to 30-minute procedure. Another study showed that the number of ESIs performed in a geographic area correlates more closely with how many doctors in that area are trained in the procedure than how many patients in the area need the procedure.
In fact, today, general practitioners, physician assistants – even some dentists and chiropractors – have started offering ESIs. Some doctors spend just one weekend learning the delicate procedure at training centers that teach cosmetic injections like Botox and fillers, but also teach doctors how to poke around people’s spines. One weekend training center advertises epidural steroid injections as “lucrative specialty options” that “create dramatic earnings for your practice.”
Not Effective for Most
Are epidural steroid injections worth the risk? In a March 2013 paper published in Surgical Neurology International, Dr. Nancy Epstein of Winthrop University Hospital in New York, put it more bluntly than any doctor to date: “The multitide of risks attributed to these injections outweighs the benefits,” she wrote. Epstein went on to say, “These procedures are not FDA approved, and, according to the majority of the literature, are both ineffective and unsafe.”
Several studies over the decades have concluded that injecting steroids epidurally works no better than injecting saline, a placebo. Other studies have shown that receiving epidural steroid injections does not help a patient avoid back surgery – and may even increase surgery rates.
All three major pain societies, The American Pain Society, The American Society of Interventional Pain Physicians, and the American Academy of Neurology, stated that ESIs are best suited for a diagnosis of radiculopathy, a pinched or inflamed nerve root with pain radiating down your leg. This diagnosis only fits a small minority of patients. Most insurance companies also take this approach, paying for epidural steroid injections only for patients who have “radiating pain” or “radiculopathy.”
The Dr. Oz Show explored two alternative treatments that have worked for some patients and could be worth trying before taking more serious steps. Here they are:
Vitamin D: Some studies have shown patients back pain decreases as their vitamin D level increases. Dr. Oz said 83% of people with chronic back pain have low vitamin D levels. He suggested patients get tested and take vitamin D supplements, if needed, to get their vitamin D up to recommended levels.
Electro-Acupuncture: Some patients with low back pain have benefited from Electro-Acupuncture, studies show. The acupuncturist places tiny needles a little thicker than a human hair in the painful area of your back, then attaches electrodes to them. The electric stimulation may work to soothe sore, tight muscles.
On the show, Dr. Oz recommends ESIs only after trying other remedies and only for a narrow group of patients who have complaints of pain radiating down the leg. The show offered this advice to patients considering an ESI:
If you are still considering an ESI:
- Confirm your diagnosis. Make sure that you have the one diagnosis that may respond to ESIs: a pinched or inflammed nerve with radiating pain. This is sometimes called a “herniated” or “bulging” disc with “radiculopathy” or “sciatica.”
- Give it time. Most back pain resolves on its own with rest and physical therapy. Try these for at least 6 weeks, the typical time frame after which patients see improvement. Only get an injection if you are seeing zero progress after this conservative wait-and-see period.
- Look for an experienced doctor. If you are going to try an epidural steroid injection, choose a doctor who is board certified in a relevant specialty and had extensive ESI training, rather than a weekend course. Avoid doctors who automatically recommend an entire course of steroid shots rather than trying just one to see if it will help you.
- X-ray guidance. Most ESIs today are performed under “fluoroscopic guidance,” kind of like a live X-ray, so that the doctor can position the needle correctly in the epidural space before releasing the medication. Insist on this as part of your treatment.
- Procedure or operating room. Go to a surgery center or hospital with a sterile environment. Your back should be swabbed with sterile solution and draped to lessen the chances of germs from your own skin entering the injection site. One advantage to getting an ESI at a hospital is that the doctors there do not work on their own. They are overseen by the hospital’s credentialing committee.
About the author: Elisabeth Leamy is a nationally known journalist, author and speaker who’s survived more than 20 years in the broadcast news business. Elisabeth’s newest role is as an investigative correspondent for the Dr. Oz Show. Her mission is to delve deeper into medical topics that impact you and your health.
Elisabeth is also the Consumer Correspondent for ABC News. Since 2005, she’s contributed to Good Morning America, World News, Nightline and 20/20. Recent highlights include her series Show Me the Money, where she has reunited people with nearly $2 million worth of unclaimed money. Elisabeth’s Nightline investigation, “Collecting from the Collectors” was the most-read feature on ABC’s website in 2012, with more than 9.5 million page views. In 2010, ABC tapped Elisabeth to conduct an exclusive interview with President Barack Obama about the new Wall Street Reform and Consumer Financial Protection Act.
Elisabeth is the author of two books. Her most recent is Save Big: Cut Your Top 5 Costs and Save Thousands (Wiley, 2010). Her first book was The Savvy Consumer: How to Avoid Scams and Rip-Offs That Cost You Time and Money(Capital Books, 2004).
As she worked her way up in television news, Elisabeth worked at local stations in Washington, DC, Tampa, FL and Bakersfield, CA. Elisabeth got her Master’s in Journalism from Northwestern University and a Bachelor’s in Rhetoric and Mass Communication from The University of California at Berkeley. She grew up in Marin County California and now lives in Washington, DC, with her husband and young daughter.