FDA
8th December 2014

FDA Panel Votes in Favor of Contraindication for Particulate Steroids

In a two-day meeting from November 24th to the 25h, the Anesthetic and Analgesic Drugs Advisory Committee (AADAC) met to discuss the risk of serious neurologic adverse reactions.

FDA Panel Votes in Favor of Contraindication for Particulate Steroids

In a two-day meeting from November 24th to the 25h, the Anesthetic and Analgesic Drugs Advisory Committee (AADAC) met to discuss the risk of serious neurologic adverse reactions associated with epidural steroid injections (ESI) administered to reduce inflammation for pain management. At this meeting, the committee also considered the efficacy of ESI and the overall risk benefit balance of injecting steroids in the epidural space to treat pain. These considerations were to assist the Agency in potential regulatory action, including but not limited to changes to the product labeling. The materials for this meeting can be found HERE.

Overall, the panel’s recommendation(s) to the Agency did not include issuing a strong warning against the general use of steroid injections for neck or back pain.

At this meeting, there were three discussion questions and one voting question. Discussions primarily revolved around the evidence surrounding the benefits and risks of epidural steroid injections for pain management. Based on these discussions, the panel was asked to vote on whether they felt that the FDA should add a contraindication to the labeling of injectable corticosteroids for the use of these products in epidural administration.

The panel was asked whether they felt there are any clinical situations for which a contraindication is warranted on the label of injectable corticosteroids. The panel voted 15-7 (with one abstention) in favor of calling so-called “particulate” steroids contraindicated for epidural injection because they appear to carry greater risk of adverse neurological effects than “nonparticulate” or soluble agents. Importantly, many of the panel members who voted yes, felt that there should not be a contraindication for the soluble form of steroids, leaving the use of injectable steroids for neck and back pain largely unchanged.

Most of the panel members who voted ‘no’ said the contraindication would be too restrictive, and would prefer label warnings on the risks of such injections; specifically for transforaminal cervical injections using particulate steroids.

Jeffrey Kirsch, MD, professor and chair of the department of anesthesiology and perioperative medicine at the Oregon Health and Science University of Portland, Oregon, voted yes, “I think it’s too risky to administer particulate medications in the cervical region because of the risk of interarterial injection, which I believe causes the contraindication.”

Edward Michna, MD, JD, RPH, director of Pain Trials at Brigham and Women’s Hospital in Boston, voted no. Dr. Michna opposed label language that contraindicates particulate steroids for epidural use, but said he would support a warning on transforaminal cervical injections with particulate steroids.

Transforaminal injections, or those delivered at the opening of the spine where a nerve root exists, may be more effective for pain reduction than others (e.g. intralaminar (mid-line) or caudal), but it was argued that their proximity to an artery may also increase the risk of an embolic event.

S. Raymond Golish, MD, PhD, a spinal surgeon and medical director of research at Jupiter Medical Center in Palm Beach, FL, also voted no; stating that the current warning is broad enough to encompass “the known risks.” He added, “I think the most worrisome practices we’ve discussed are being eliminated in the clinical practice of medicine by increased awareness and leadership.”

Several committee members noted that more research on both particulate and nonparticulate steroids is needed, but some noted that there was no need to duplicate the animal studies in humans. “You don’t need to prove that a gun’s going to kill you [for you] not to use it,” noted John Farrar, MD, PhD, associate professor of epidemiology, neurology and anesthesia at the University of Pennsylvania and senior scholar at the Center for Clinical Epidemiology and Biostatistics.

The FDA is not obligated to follow the advice of its panels, but normally does so.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComs per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

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