September 19 , 2007

FDA ALERT

 

FDA MedWatch: Haloperidol Marketed As Haldol, Haldol Decanoate, And Haldol Lactate Get New Warnings And Revised Prescription Information

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Johnson and Johnson and FDA informed healthcare professionals that the WARNINGS section of the prescribing information for haloperidol has been revised to include a new Cardiovascular subsection regarding cases of sudden death, QT prolongation and Torsades de Pointes(TdP) in patients treated with haloperidol, especially when given intravenously, or at doses higher than recommended. Although injectable haloperidol is only approved by the FDA for intramuscular injection, there is considerable evidence that the intravenous administration of haloperidol is a relatively common off-label clinical practice.

There are at least 28 case reports of QT prolongation and TdP, some with fatal outcome in the context of off-label intravenous haloperidol.

Healthcare professionals should consider this new risk information when making individual treatment decisions for their patients.


Read the complete MedWatch 2007 Safety Summary including a link to the Healthcare Professional Sheet at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Haloperidol