The U.S. Food and Drug Administration (FDA) has issued a new draft guidance designed to help applicants add clinically relevant information about QTc interval prolongation to the labeling of non-antiarrhythmic drugs.
Some medications, the agency warned, are associated with a risk of delaying cardiac repolarization.
“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,” according to the FDA’s draft document. “The risk of TdP may also be increased for patients with risk factors for QT interval prolongation.”
The FDA and International Council for Harmonisation (ICH)—a global nonprofit focused on the development and registration of new medications—both recommend that healthcare and pharmaceutical companies developing new medications “assess the effect of cardiac repolarization early in clinical development, including a clinical electrocardiographic evaluation.” This may help guide the development of late-phase clinical trials, according to the FDA’s guidance.
FDA/ICH recommendations also include conducting a “single clinical trial” to assess the effect of any given drug on QTc interval.
Another key takeaway from the new draft guidance is that the concomitant use of more than one drug known or suspected to prolong a patient’s QTc interval may “further increase the risk of clinically significant adverse reactions.” This is something applicants should keep in mind when finalizing their labeling information, the FDA explained.
The full guidance document, “QTc Information in Human Prescription Drug and Biological Product Labeling,” is available here. While comments can be submitted at any time, the deadline to have the FDA consider your feedback before writing its final guidance is Oct. 10, 2023.
QT prolongation from drugs became a key concern by the FDA and made headlines in mainstream media during the COVID-19 pandemic. Numerous reports and studies found hydroxychloroquine and azithromycin used to treat the virus were found to cause QT prolongation. Read more.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.