Recommendations for safe use of epidural steroid injections presented at the ANESTHESIOLOGY™ 2013 annual meeting as part of FDA’s Safe Use Initiative

Recommendations for the safe use of interlaminar and transforaminal epidural steroid injections, as part of a collaborative effort facilitated by the U.S. Food and Drug Administration’s (FDA’s) Safe Use Initiative, were today presented at a special panel during the ANESTHESIOLOGY™ 2013 annual meeting.

FDA’s Safe Use Initiative facilitated the convening of experts and professional organizations in a Work Group, and supported them in their effort to develop consensus recommendations to promote the safe use of epidural steroid injections.  This Work Group is composed of pain management experts, and physicians from the American Society of Anesthesiologists (ASA) and several other national medical organizations. After analyzing and discussing the use, risks and complications of epidural steroid injections, the workgroup developed recommendations for their use, and concluded the following:

• There is an increased chance of neurologic injury when particulate steroids are used for transforaminal injections.
• There is an increased chance of neurologic injury with transforaminal epidural approach compared to the interlaminar approach.
• Use of image-guidance is mandatory when performing transforaminal injections.

“FDA’s Safe Use Initiative is pleased to facilitate the collaboration of clinical experts and pain management organizations whose ultimate goal is to minimize the risk of epidural steroid injection-related neurologic injuries,” said Dale Slavin, Ph.D., director of FDA’s Safe Use Initiative.

FDA launched the Safe Use Initiative on November 4, 2009. The mission of the Safe Use Initiative is to create and facilitate public and private collaborations within the health care community to measurably reduce preventable medication injury and improve patient health through coordinated and focused non-regulatory efforts. FDA’s Safe Use Initiative seeks to accomplish these goals by identifying specific medication risks, and, in collaboration with partners who are committed to safe medication use, develop, implement and evaluate cross-sector interventions.

“It was essential that physicians from across multiple disciplines, including anesthesiology, orthopedics and radiology, came together to develop these recommendations in the best interest of patient safety,” said panelist James P. Rathmell, M.D., Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston. “We believe these recommendations will help prevent complications from the use of steroid injections, including stroke, brain stem damage, paraplegia and death.”

The Work Group has assembled and agreed upon a comprehensive set of evidence-based recommendations aimed at using our current scientific knowledge to guide practitioners about how to perform epidural steroid injections in the safest possible way to minimize this risk of patient injury. The practice recommendations will be published later this year in the peer-reviewed literature and this information will be widely disseminated to all practitioners with the help of the FDA’s Safe Use Initiative.

Rathmell adds, “The goal of our entire project is to assure that each and every practitioner performing epidural steroid injections understands how and why these serious complications can occur and, most importantly, how they can perform the injections in the absolutely safest manner. I believe this unique collaboration between physicians, pain management organizations and the Safe Use Initiative will assure that the best scientific information is available to all.”