An In-Depth Investigation: Epidural Steroid Injections

By Elisabeth Leamy Investigative Correspondent Follow Elisabeth on Twitter: @ElisabethLeamy

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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.)

Other Complications

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. 

Article written by Elisabeth Leamy
Investigative Correspondent