Risks of off-label use of Haldol added to PI

September 19, 2007

Intravenous injection of haloperidol (Haldol) may cause QT prolongation and torsades de pointes

Although haloperidol (Haldol, Johnson & Johnson) is approved for intramuscular use, off-label intravenous use of the drug is relatively common for treating severe agitation in intensive care units. However, due to a number of case reports of QT prolongation, torsades de pointes, and sudden death thought to be associated with this practice, the FDA has issued an alert to healthcare professionals. The prescribing information for Haldol, Haldol Decanoate, and Haldol Lactate has been revised to reflect the concern and potential risk when the drug is administered intravenously or at higher doses than recommended.

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