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Back Pain Procedure Under Investigation

The U.S. Food and Drug Administration is reviewing the safety of a popular back-pain relieving procedure after severe side effects were reported.

According to a Dec. 28 article in Bloomberg Business Week, a surge in steroid injections into the epidural space near the spinal cord used to alleviate back and neck pain in the U.S. is bringing with it an increase in severe complications, including paralysis and death.

The FDA is reviewing the procedure in consultation with an advisory group.

The BBW article states that last year 8.9 million Americans received the shot which take minutes to administer and brings doctors generous reimbursements from Medicare and private insurers.

According to studies, steroid shots have become the most popular way U.S. doctors treat neck and back pain and one study states the number of injections to Medicare patients increased 159 percent between 2000 and 2010.

Spending on pain treatments in general is estimated at $300 billion per year according to BBW, and epidurals cost Americans $23 billion in 2011 according to Marketdata Enterprises Inc., a Tampa-based company that has been tracking the pain medication market since 1992.

According to BBW, doctors say the rise in injections is driven by an “aging population prone to back and neck pain and generous reimbursements for treatment.”

BBW claims Medicare pays about $200 for an epidural steroid shot in a doctor’s office, $400 at a surgery center, and $600 in a hospital. Private insurance companies pay as much as 150 percent of Medicare rates.

The FDA review which is focusing on steroid injections that come within millimeters of critical arteries feeding the spinal cord is being conducted by its Safe Use Initiative, formed in 2009 to reduce preventable harm from medications. The article stated about half of all epidural steroid shots are administered in this manner.

Another concern is using steroids such as Kenalog and Depo-Medrol and their generic versions which are slow to dissolve and may create blockages that trigger strokes if accidentally shot into arteries according to doctors advising the FDA study.

Studies also suggest that too many shots may be given at too close intervals.

The North American Spine Society suggests a maximum of four injections within six months for cervical epidurals, but added that setting an absolute limit would restrict some patients from getting necessary care.

The American Society of Anesthesiologists does not say how many shots are appropriate.

On its website, The Mayo Clinic tells patients shots are usually restricted to a few each year because steroids can weaken spinal bones and nearby muscles and upset the natural hormone balance, leading to potentially serious medical conditions and the risk of side effects may increase with the number of steroid injections.

An FDA spokeswoman told BBW it was too early to know what, if any action would be taken.