fda-approvals

An Rx to Reverse Muscle Relaxants During Surgery

Bridion (sugammadex) injection FDA-approved to reverse neuromuscular blockade induced by rocuronium bromide, vecuronium bromide

By RxWiki Staff
December 16, 2015 · 1 min read
An Rx to Reverse Muscle Relaxants During Surgery

Certain surgeries require medications called muscle relaxants to keep patients from moving. And now there's a medication to reverse the effects of two common muscle relaxants.

That drug is called Bridion (sugammadex). The US Food and Drug Administration (FDA) approved it Tuesday to reverse the effects of rocuronium bromide (brand name Zemuron) and vecuronium bromide (Norcuron), which are often used at the start of surgeries that require surgeons to insert a breathing tube — a process called intubation.

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

Three late-stage clinical trials — covering 456 patients — evaluated this newly approved Merck drug. Compared to patients who didn't receive Bridion, those who did recovered from the effects of rocuronium and vecuronium faster.

Another trial assessed Bridion for its risk of triggering a potentially life-threatening allergic reaction called anaphylaxis. Of the 299 patients in this trial, one had the reaction.

The FDA noted that doctors should monitor patients for anaphylaxis and bradycardia, an abnormally slow heart rate. Other adverse reactions included nausea, vomiting, pain and low blood pressure, among others.

Written by
RxWiki Staff
Editorial Team

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