FDA approves Bridion to reverse effects of neuromuscular blocking drugs

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.