Inapsine - Warnings and Precautions Strengthened

December 07, 2001

FDA and Akorn Pharmaceuticals added a "black box" warning and strengthenedthe WARNINGS and PRECAUTIONS sections in the labeling for Inapsine, atranquilizer used as a premedication for anesthesia, as treatment for nauseaafter anesthesia, and for sedation of agitated patients. Cases of QT prolongation and/or torsades de pointes have been reported at doses at orbelow recommended doses. Some cases have occurred in patients with no knownrisk factors for QT prolongation and some cases have been fatal.

Click here for links to the Dear Health Professional letter and FDA Talk Paper