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QTc Draft Guidance For Non-Antiarrhythmic Drugs: ‘Reasonable Evidence’ Of Causal Cardiac Events Should Result In Boxed Warning

 
• By Kate Rawson

US FDA’s labeling guidance also outlines a number of steps sponsors should take to prevent or mitigate risks associated with QTc interval prolongation.

Electrocardiogram_supraventricular_tachycardia_and_colored_pills
• Source: Shutterstock

The US Food & Drug Administration is advising sponsors that non-antiarrhythmic drugs found to prolong the QTc interval should include detailed information about the increased rate of potential proarrhythmic events – such as torsade de pointes, ventricular tachycardia or sudden death – in the “Warnings and Precautions” section of labeling.

In a draft guidance to industry, “QTc Information in Human Prescription Drug and Biological Product Labeling,” the agency outlines...

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