Audience: Anesthesiologists and other healthcare professionals
FDA and Akorn Pharmaceuticals added a "black box" warning and strengthened the WARNINGS and PRECAUTIONS sections in the labeling for Inapsine, a tranquilizer used as a premedication for anesthesia, as treatment for nausea after anesthesia, and for sedation of agitated patients. Cases of QT prolongation and/or torsades de pointes have been reported at doses at or below recommended doses. Some cases have occurred in patients with no known risk factors for QT prolongation and some cases have been fatal.
[December 06, 2001 - Letter - FDA]