FDA Approves Bridion to Reverse the Effects of Neuromuscular Blockade

The FDA has approved sugammadex (Bridion) to reverse the effects of neuromuscular blockade created by rocuronium bromide and vercuronium bromide.

The FDA based its approval on data from 3 phase 3 clinical trials involving 456 patients.

Those who received Bridion had faster recovery times compared with control groups. Most of the patients recovered within 5 minutes of using the intervention treatment.

Rocuronium bromide and vercuronium bromide, which are used during certain types of surgery, cause temporary paralysis for patients requiring an artificial airway or breathing tube. The drugs can also be used to prevent patients from moving while they undergo general anesthesia.

"Bridion provides a new treatment option that may help patients recover sooner from medications used for intubation or ventilation during surgery,” said Sharon Hertz, director of the Division of Anesthesia, Analgesia, and Addiction Products in the FDA’s Center for Drug Evaluation and Research, in a press release. “This drug enables medical personnel to reverse the effects of neuromuscular blocking drugs and restore spontaneous breathing after surgery.”

Adverse effects include anaphylaxis, vomiting, low blood pressure, pain, headache, and nausea.

Health care professionals are encouraged to discuss all of the potential adverse effects, including anaphylaxis, with their patients.