New antiarrhythmic agent gets FDA approval

FDA has approved sotalol hydrochloride oral solution (Sotylize, Arbor Pharmaceuticals) for the treatment of documented life-threatening ventricular arrhythmias and the maintenance of normal sinus rhythm in patients with a history of highly symptomatic atrial fibrillation/flutter.

Atrial fibrillation is the most common type of arrhythmia which involves a very fast and irregular contraction of the atria caused by abnormal signaling in the heart. Atrial flutter is similar to atrial fibrillation but is described as a regular rhythm. Both atrial conditions can lead to serious complications such as stroke and heart failure.

Ventricular arrhythmias include ventricular tachycardia which is a fast, regular beating of the heart, and ventricular fibrillation which is characterized by disorganized electrical signals that prevent the heart from pumping normally. If left untreated, both types can be very dangerous and potentially fatal.

Sotylize is an antiarrhythmic with Class II beta-adrenergic receptor blocking properties as well as Class III cardiac action potential duration prolongation properties. Together, these mechanisms act to improve the heart’s rhythm and prevent the potential for arrhythmias.

Sotylize is the first and only sotalol oral solution indicated for the treatment of ventricular arrhythmias and maintenance of normal sinus rhythm in atrial fibrillation and flutter. Prior to the approval, sotalol was only available in tablet form. Because it was such a common practice to use the tablet form to compound an oral solution, FDA changed the tablet label to include instructions for how to compound the sotalol suspension.

Sotylize has a boxed warning describing the risk of life-threatening ventricular tachycardia associated with QT prolongation and is therefore contraindicated in patients with a QT interval greater than 450 milliseconds. It is also contraindicated in sinus bradycardia, uncontrolled heart failure and a creatinine clearance less than 40 mL/min. The most common adverse effects associated with Sotylize include fatigue, bradycardia, dizziness, and headache. 

Erin Bastick is a PharmD Candidate 2016, Ohio Northern University, Ada, Ohio, and an inpatient intern at University Hospitals, Cleveland.

Related

FDA approves implantable wireless device with remote monitoring to measure PA pressure in certain heart failure patients

Heart-related hospitalizations, deaths reduced due to coordinated care efforts

Heart failure