Bretylium, a Class III Antiarrhythmic, Returns to the Market

Link to article at PubMed

Am J Cardiol. 2020 Jul 28:S0002-9149(20)30788-8. doi: 10.1016/j.amjcard.2020.07.053. Online ahead of print.


Bretylium, with an extensive pharmacologic and medicinal history, was approved by the United States Food and Drug Administration in 1986 for "short-term prevention and treatment of ventricular fibrillation (VF) and treatment of life-threatening ventricular arrhythmias and ventricular tachycardia (VT) unresponsive to adequate doses of a first-line antiarrhythmic agent, such as lidocaine." The NDA sponsor withdrew bretylium from the market in 2011, largely due to unavailability of raw materials required for its production; prior to this, bretylium was removed from the 2000 ACLS Guidelines algorithm for VF/pulseless VT given the challenges obtaining raw materials for drug manufacture. Recently, bretylium has been reintroduced into the US market by a generic pharmaceutical company with the same indications as before. This article provides a history of the salient trials evaluating the efficacy and safety of bretylium and looks to the future as bretylium finds its place in the modern day management of ventricular arrhythmia.

PMID:32843146 | DOI:10.1016/j.amjcard.2020.07.053

Leave a Reply

Your email address will not be published. Required fields are marked *