December 02, 2014
FDA Advisory Committee Recommends Contraindication for Transforaminal Cervical Injections with Particulate Steroids
On November 24-25, the FDA Anesthetic and Analgesic Drug Products Advisory Committee met to discuss the efficacy of epidural steroid injections and the risk of serious neurologic adverse reactions. The committee voted 15-7, with one abstention, that there are clinical situations for which a contraindication is warranted for epidural corticosteroid injections and recommended that the FDA issue a contraindication for transforaminal cervical injections with particulate steroids.
This Advisory Committee meeting follows an April 23, 2014 FDA Drug Safety Communication warning 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.” As a result, the FDA stated that it would require the addition of a Warning to injectable corticosteroids’ drug labels to describe these risks and recommended that “patients should discuss the benefits and risks of epidural corticosteroid injections with their health care professionals, along with the benefits and risks associated with other possible treatments.”
At the Advisory Committee meeting, John Dombrowski, M.D., ASA’s Assistant Secretary and member of the Committee on Pain Medicine, urged the FDA to retract the Warning and expressed concern that the Warning does not differentiate between the risks and benefits of transforaminal and interlaminar routes of administration, and particulate and non-particulate formulations of steroids. This testimony follows an ASA-led multisociety sign-on letter to the FDA expressing concern with the FDA Warning, and two letters that ASA joined which were submitted by the American Academy of Pain Medicine and the International Spine Intervention Society.
The FDA will take the Advisory Committee’s vote and discussion under consideration as it determines whether further action is warranted.