FDA approves Bridion — 7 things to know

The FDA approved Bridion injections to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide.

Here are seven things to know:

1. 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 chords when patients require an artificial airway or breathing tube for surgery.

2. The drugs can also be used to prevent patients from moving during surgery while they are receiving general anesthesia.

3. Neuromuscular blocking drugs are also sometimes used to prevent the body from breaking automatically when a patient is placed on a ventilator.

4. The safety and efficacy of Bridion were evaluated in three Phase 3 clinical trials involving 456 participants. The return recovery time was faster overall for the Bridion treatment groups compared to the comparator groups, with most participants recovering within five minutes of routine use of Bridion.

5. Due to concerns about the nature and frequency of anaphylaxis 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.

6. The most common adverse reactions reported in the clinical trials included vomiting, low blood pressure, pain, headache and nausea.

7. Bridion is marketed by Merck Sharp and Dohme, a subsidiary of Merck and Company based in Whitehouse Station, N.J.

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