Bridion (sugammadex) has been approved by the U.S. Food and Drug Administration to reverse the effects of medications that are used to paralyze the vocal chords during certain surgical procedures.
Rocuronium bromide and vecuronium bromide are prescribed when surgeons use an artificial airway or breathing tube, a process called tracheal intubation, the FDA said Tuesday in a news release. These so-called “neuromuscular blocking drugs” also may be used to prevent a person receiving general anesthesia from moving during surgery, or to prevent a person from breathing automatically while on a ventilator, the FDA added.
In clinical studies involving more than 450 people, Bridion was evaluated in reversing the effects of these drugs. Most people 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 an abnormal slowing of the heart, which could lead to cardiac arrest, the FDA said.
More common and less severe side effects of Bridion could include vomiting, low blood pressure, pain, headache and nausea. The drug also could reduce the effectiveness of certain hormonal contraceptives taken by women, the FDA said.
Bridion is marketed by a subsidiary of Merck and Co., based in Whitehouse Station, N.J.
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