FDA Approves Bridion to Reverse Neuromuscular Blockade
Drug reverses the effects of rocuronium bromide and vecuronium bromide
WEDNESDAY, Dec. 16, 2015 (HealthDay News) -- Bridion (sugammadex) has been approved by the U.S. Food and Drug Administration to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide.
The neuromuscular blocking drugs are used to paralyze the vocal cords during tracheal intubation, to prevent a patient receiving general anesthesia from moving during surgery, or to prevent a patient from breathing automatically while on a ventilator, the FDA said.
In clinical studies involving 456 patients, Bridion was evaluated in reversing the effects of these drugs. Most of the patients who received Bridion recovered within 5 minutes of its use, the FDA said. However, the agency warned of the possibility of life-threatening allergic-like reaction to Bridion, an outcome that affected one of 299 clinical trial participants given the drug. Another possible severe reaction is marked bradycardia, which could lead to cardiac arrest, the FDA said. More common and less severe side effects of Bridion could include vomiting, hypotension, pain, headache, and nausea. The drug also could reduce the effectiveness of certain hormonal contraceptives taken by women.
"Bridion provides a new treatment option that may help patients recover sooner from medications used for intubation or ventilation during surgery," Sharon Hertz, M.D., director of the Division of Anesthesia, Analgesia and Addiction Products in the FDA's Center for Drug Evaluation and Research, said in a statement. "This drug enables medical personnel to reverse the effects of neuromuscular blocking drugs and restore spontaneous breathing after surgery."
Bridion is marketed by a subsidiary of Merck and Co., based in Whitehouse Station, N.J.