For Immediate Release
December 15, 2015
The U.S. Food and Drug Administration today approved Bridion (sugammadex) injection 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 muscle and are used to paralyze the vocal cords when patients require an artificial airway or breathing tube for surgery, a process called 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 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, M.D., 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.
The most common adverse reactions reported in clinical trials included vomiting, low blood pressure (hypotension), pain, headache and nausea. Doctors should also advise women using hormonal contraceptives that Bridion may temporarily reduce the contraceptive effect so they must use an alternate method of birth control for a period of time.
Bridion is marketed by Merck Sharp and Dohme Corp., a subsidiary of Merck and Company, Inc., based in Whitehouse Station, New Jersey.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.