• FDA Finally Approves Neuromuscular Blockade Reversal
Drug.
After a long uphill battle, the makers of sugammadex,
which can be used to reverse neuromuscular blockade induced by
rocuronium or vecuronium, finally have permission to sell their
drug in the United States. Marketed as Bridion, the drug has
been used in at least 70 other countries for years, but Merck
and Co., which acquired it as part of a merger in 2009, has
had to overcome numerous hurdles to gain FDA approval.
The FDA first rejected Bridion in 2008, citing concerns about
allergic reactions and increased risks of bleeding. A further
series of setbacks followed in 2013, as the agency ques-
tioned clinical studies and expressed concern that the drug
might trigger hypersensitivity. Hopes that the drug would be
approved early in 2015 were dashed when the FDA
announced that it wanted to conduct additional site inspections. Approval, which finally came in
December, followed 3 clinical trials and a randomized, double-blind, parallel-group, repeat-dose
trial. Of the 299 participants in the latter trial, one had an anaphylactic reaction. There have
also been cases of marked bradycardia resulting in cardiac arrest. Patients should be closely
monitored for hemodynamic changes during and after reversal of neuromuscular blockade, says
the FDA (osmag.net/6oRgUH), and treatment with anticholinergic agents, such as atropine,
should be administered if clinically significant bradycardia is observed.
• New substance a gift from above? An amino acid that literally fell from the sky shows
promise as an alternative to opioids for anesthesia and procedural sedation, according to a new
study published in Anesthesia & Analgesia (osmag.net/Bht6ZT). Isovaline, which was contained
in a meteorite that landed in Australia in 1969, and which has since been synthesized, acts only
on peripheral neuroreceptors outside the central nervous system and does not cross the blood-
Anesthesia Alert
AA
1 5 4 • O U T PA T I E N T S U R G E R Y M A G A Z I N E • F E B R U A R Y 2 0 1 6
Anesthesia News and Notes
