The US Food and Drug Administration (FDA) has approved sugammadex injection (Bridion, Merck) for the reversal of moderate or deep neuromuscular blockade induced by rocuronium or vecuronium during surgery, according to an agency news release.
The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee recommended approval of the drug back in November.
Sugammadex binds to rocuronium and vecuronium, two neuromuscular blocking agents used to facilitate endotracheal intubation and mechanical ventilation during surgery. Sugammadex reverses the paralysis induced by the two drugs.
“Bridion provides a new treatment option that may help patients recover sooner from medications used for intubation or ventilation during surgery,” Sharon Hertz, MD, director of the Division of Anesthesia, Analgesia and Addiction Products in the FDA’s Center for Drug Evaluation and Research, said in therelease. “This drug enables medical personnel to reverse the effects of neuromuscular blocking drugs and restore spontaneous breathing after surgery.”
The safety and efficacy of sugammadex were tested in three phase 3 trials involving 456 adults. The return to recovery time was faster overall in the sugammadex treatment groups relative to comparator groups, with most participants recovering within 5 minutes of treatment, the FDA said.
Because of concerns about the nature and frequency of anaphylaxis and hypersensitivity reactions reported in the clinical trials, sugammadex was further evaluated in a randomized, double-blind, parallel-group, repeat-dose trial. Of the 299 participants treated with sugammadex, only one had an anaphylactic reaction.
“Clinicians should be aware of the possibility of a hypersensitivity reaction or anaphylaxis and should intervene as appropriate,” the FDA said.
They also note that cases of marked bradycardia, some of which have led to cardiac arrest, have been observed within minutes after administration of sugammadex. They advise monitoring patients closely for hemodynamic changes during and after reversal of neuromuscular blockade and administering anticholinergic agents, such as atropine, if clinically significant bradycardia is observed.
The most common adverse reactions reported in clinical trials of sugammadex included vomiting, hypotension, pain, headache, and nausea. Health providers should also advise women using hormonal contraceptives that sugammadex may temporarily reduce the contraceptive effect, so they must use an alternate method of birth control for a period of time.