April 30, 2014 — The U.S. Food and Drug Administration (FDA) recently issued a severe warning against the use of epidural corticosteroid injections for pain. The warning cautions “…that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death.”
Epidural injections to treat neck pain, back pain and radiating pain in the arms and legs are commonly used and have been in widespread use for decades. However, the effectiveness and safety of epidural injections of corticosteroids, such as hydrocortisone and methylprednisolone, have not been established. As a result, the FDA is requiring the addition of a warning to the drug labels of injectable corticosteroids to describe the risks associated with the off label use. It is estimated that approximately 9 million epidural injections are administered annually in the U.S. Other major industrialized nations have already placed highly restrictive limits and safeguards on the use of steroid injections.
“This is exactly why Integrity Life Sciences is determined to communicate the effectiveness of its non-surgical spinal decompression systems,” said James Gibson, president and CEO of Integrity Life Sciences, when asked about non-invasive treatment alternatives for back and neck pain.
“The recent FDA actions highlight the harsh reality that invasive and traditional pharmaceutical treatment of chronic neck and low back pain are not without risk,” he continued. “Due to the potential high risk and limited long term benefits associated with the treatment, a growing trend of doctors in pain management and obstetrics refuse to prescribe epidural injections. The underlying message from the FDA is clear that the effectiveness of steroid injections has not been established and that the treatment of back and neck pain is an evolving science.”
The FDA is formulating a Scientific Committee in the fall of 2014 to further address the risk versus reward of the controversial treatment of low back pain. Integrity Life Sciences is advocating for a seat at the panel when it is convened. A focus of the panel should be the constructive treatment therapy options utilizing Integrity’s non-surgical spinal decompression systems (ISCS). The ISCS with zero reported adverse events and an industry body of literature that establishes its effectiveness should be documented as a viable and safe treatment option and the stigmatization of questionable reimbursement defined.
The FDA warning may be viewed at: http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm394530.htm.
Source: Integrity Life Sciences