The US Food and Drug Administration has approved Bridion (sugammadex, Merck Sharp and Dohme Corp — a subsidiary of Merck & Co) injection to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide, which are used to facilitate intubation procedures and mechanical ventilation.
Rocuronium bromide and vecuronium bromide cause temporary paralysis by interfering with the transmission of nerve impulses to the muscle, according to the FDA. The drugs are used to paralyze the vocal cords when patients require tracheal intubation. In addition, they can be used to prevent patients under general anesthesia from moving during surgery. Neuromuscular blocking drugs are also sometimes used to prevent the body from breathing automatically when a patient has to be placed on a ventilator.
“Bridion provides a new treatment option that may help patients recover sooner from medications used for intubation or ventilation during surgery,” said Sharon Hertz, MD, director of the Division of Anesthesia, Analgesia and Addiction Products in the FDA’s Center for Drug Evaluation and Research. “This drug enables medical personnel to reverse the effects of neuromuscular blocking drugs and restore spontaneous breathing after surgery.”
The safety and efficacy of Bridion were evaluated in three Phase 3 clinical trials involving 456 participants. The return to recovery time was faster overall for the Bridion treatment groups compared to the comparator groups, with most participants recovering within 5 minutes of routine use of Bridion.
Due to concerns about the nature and frequency of anaphylaxis (severe, potentially life-threatening allergic reaction) and hypersensitivity reactions reported in the clinical trials, Bridion was further evaluated in a randomized, double-blind, parallel-group, repeat-dose trial. Of the 299 participants treated with Bridion, one person had an anaphylactic reaction. Clinicians should be aware of the possibility of a hypersensitivity reaction or anaphylaxis and should intervene as appropriate.
Cases of marked bradycardia (abnormally slow heart action), some of which have resulted in cardiac arrest, have been observed within minutes after the administration of Bridion. Patients should be closely monitored for hemodynamic changes during and after reversal of neuromuscular blockade, and treatment with anticholinergic agents, such as atropine, should be administered if clinically significant bradycardia is observed.