The US Food and Drug Administration (FDA) on Monday issued draft guidance offering recommendations for sponsors to include labeling information on QTc interval prolongation for certain heart drugs, which can increase the risk for torsade de pointes (TdP) and eventually lead to potentially fatal complications, such as ventricular fibrillation.
Patients who are prescribed non-antiarrhythmic drugs, such as angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and corticosteroids to prevent atrial fibrillation (AF) may experience delayed cardiac repolarization.
“An undesirable property of some non-antiarrhythmic drugs is their ability to delay cardiac repolarization, an effect that can be measured as prolongation of the QT interval on the surface electrocardiogram (ECG),” said FDA. “A delay in cardiac repolarization creates an electrophysiological environment that favors the development of torsade de pointes (TdP), which can degenerate into ventricular fibrillation, leading to sudden death.”…
