FDA Approves Sugammadex to Reverse Neuromuscular Blockade

On December 15, the U.S. Food and Drug Administration (FDA) approved sugammadex to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide.  This follows a FDA Anesthetic and Analgesic Drug Products Advisory Committee meeting in which they voted in favor of the FDA approving sugammadex.  Over the past several years, ASA has formally communicated to the FDA that there is a need for a drug to provide physician anesthesiologists with better capabilities to reverse neuromuscular blockade induced by rocuronium or vercuronium.   In the most recent formal communication to the FDA Advisory Committee, the American Society of Anesthesiologists stated that a novel, unique drug with these capabilities “would significantly enhance the ability of physician anesthesiologists to more safely care for patients and reduce the incidence of critical respiratory adverse events in the PACU, especially for patients most at risk.”

The FDA’s press release on the drug’s approval is available here: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm477512.htm