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FDA Approves Sugammadix (Bridion) to Reverse Effects of Neuromuscular Blockers During Surgery
The FDA has given the green light to sugammadex injection (Bridion, Merck) to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide, which are used during certain types of surgery in adults.
Rocuronium bromide and vecuronium bromide are neuromuscular blocking drugs that cause temporary paralysis by interfering with the transmission of nerve impulses to the muscles and are used to paralyze the vocal cords when patients require tracheal intubation. They can also be used to prevent patients from moving during surgery while they are receiving general anesthesia. Neuromuscular blocking drugs are also sometimes used to prevent the body from breathing automatically when a patient must be placed on a ventilator.
Sugammadex was originally developed by Organon BioSciences, which was acquired by Schering-Plough in 2007. Merck acquired the drug when it bought Schering-Plough in 2009.
In 2008 the FDA declined to approve sugammadex, citing concerns about potential allergic reactions and bleeding. A 2013 advisory panel meeting to discuss the drug was abruptly canceled after the agency said it needed more time to review the company’s revised application.
The safety and efficacy of sugammadex were evaluated in three phase 3 clinical trials involving a total of 456 participants. The return to recovery time was faster overall for the sugammadex treatment groups compared with the comparator groups, with most participants recovering within 5 minutes of routine use of sugammadex.
Because of concerns about the nature and frequency of anaphylaxis and hypersensitivity reactions reported in the clinical trials, sugammadex was also evaluated in a randomized, double-blind, parallel-group, repeat-dose trial. Of the 299 participants treated with sugammadex, one person experienced an anaphylactic reaction.
Cases of marked bradycardia, some of which have resulted in cardiac arrest, have been observed within minutes after the administration of sugammadex. Patients should be closely monitored for hemodynamic changes during and after the reversal of neuromuscular blockade, and treatment with anticholinergic agents, such as atropine, should be administered if clinically significant bradycardia is observed.
The most common adverse events observed in clinical trials included vomiting, hypotension, pain, headache, and nausea. Physicians should advise women using hormonal contraceptives that sugammadex may temporarily reduce the contraceptive effect and that they must use an alternate method of birth control for a period of time.
Sources: FDA; December 15, 2014; and Reuters; December 15, 2015.