QTc Information in Human Prescription Drug and Biological Product Labeling Guidance for Industry

https://www.fda.gov/media/170814/download?utm_medium=email&utm_source=govdelivery FDA Publishes Guidance with Recommendations on Including QTc Information in Drug Labeling The U.S. Food and Drug Administration (FDA) recently published the guidance for industry, QTc Information in Human Prescription Drug and Biological Product Labeling (December 2025). This guidance provides recommendations to help ensure clinically relevant information on heart rate-corrected QT (QTc) interval prolongation (certain changes in the electrical activity of the heart) is included in the U.S. Prescribing Information of non-antiarrhythmic prescription drugs (prescription drugs that do not treat arrhythmias). Some of these drugs can delay cardiac repolarization, an effect that can be measured on an electrocardiogram as QTc interval prolongation. This delay creates an electrophysiological environment that can contribute to torsade de pointes, which can progress to ventricular fibrillation and lead to sudden death. FDA recommends sponsors for most non-antiarrhythmic drugs with systemic bioavailability assess the effect on cardiac repolarization early in clinical development, including a clinical electrocardiographic evaluation. Examples of the guidance’s labeling recommendations: Including relevant clinical pharmacology-related information on the effects of the subject drug (the drug for which labeling is being created) on the QTc interval, including when clinically significant QTc interval prolongation was not observed. Including information on concomitant use of the subject drug with other products when the subject drug is: Known or suspected to prolong the QTc interval and the other products are also known or suspected to prolong the QTc interval. Associated with concentration-dependent QTc prolongation and the other product(s) increase concentrations of the subject drug. Including a QTc interval prolongation warning if the QTc interval prolongation is identified as a side effect or safety hazard that is serious or otherwise clinically significant because of implications for prescribing decisions or patient management. Including dosage modifications for the subject drug and the recommended frequency of ECG monitoring to reduce the risk of clinically relevant side effects of QTc interval prolongation.