Inapsine

Inapsine is currently indicated as a second line therapy for nausea and vomiting in surgical and diagnostic procedures, premedication, and neuroleptanalgesia. The FDA had issued an “Important Drug Warning” for Inapsine after it was linked to instances of fatal cardiac arrhythmias. Due to the grave effects of the Inapsine, a “black box” warning, the strongest FDA warning, was put on the Inapsine labels in hopes of better alerting physicians and patients of the deadly risks involved with Inapsine use.

The Inapsine labeling had already included a warning about cases of sudden death at high doses, or greater than 25 mg in patients at risk for cardiac arrhythmias. Recent research has shown QT prolongation within minutes after injection of a dose of Inapsine at the upper end of the labeled dose range. Prolonged QT can result in a sometimes fatal instance of torsades de pointes. The link between QTc prolongation and Inapsine was first made in December 2001 and continues to be a safety concern associated to Inapsine. The FDA’s Anesthetic & Life Support Drugs Advisory Committee plans on discussing risk management and assessment of the Inapsine link at the November 2003 meeting.
The Inapsine manufacturer also sent a "Dear Healthcare Professional" letter to physicians, pharmacists, and other healthcare professionals in the U.S. The letter explains the FDA black box Inapsine warnings and points out the potential for QT prolongation or torsades when the drug is administered. For more information on Inapsine contact us to confer with an Inapsine lawyer.