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Medication Adverse Event Alert

September 18, 2007

MEDICATION:	Haldol® (haloperidol), Johnson and Johnson or as generic haloperidol
DOSAGE FORMS:	tablets- 0.5mg, 1mg, 2mg, 5mg, 10mg, 20mg oral concentrate- 2mg/mL injection- 5mg/mL, 50mg/mL (decanoate), 100mg/mL(decanoate)
ISSUE:	New Cardiovascular subsection regarding sudden death, QT prolongation and Torsades de Pointes especially when given intravenously or at higher than recommended doses

The following was posted on the FDA News web site on September 17, 2007:

"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."

See an excerpted "Recommendations and considerations for healthcare professionals":

"Although injectable haloperidol is approved by the FDA only for intramuscular injection, there is considerable evidence from the medical literature that intravenous administration of haloperidol is a relatively common "off-label" clinical practice, primarily for treatment of severe agitation in intensive care units. Due to a number of case reports of sudden death, TdP and QT prolongation in patients treated with haloperidol (especially when the drug is given intravenously or at doses higher than recommended), the sponsor has updated the labeling for haloperidol.

The updated WARNINGS note that:

-Higher doses and intravenous administration of haloperidol appear to be associated with a higher risk of QT prolongation and TdP

-Although cases of sudden death, TdP and QT prolongation have been reported even in the absence of predisposing factors, particular caution is advised in treating patients using any formulation of haloperidol who:

• have other QT-prolonging conditions, including electrolyte imbalance (particularly hypokalemia and hypomagnesemia),
• have underlying cardiac abnormalities, hypothyroidism, or familial long QT syndrome, or
• are taking drugs known to prolong the QT interval.

-Because of this risk of TdP and QT prolongation, ECG monitoring is recommended if haloperidol is given intravenously.

-Haloperidol is not approved for intravenous administration."

The complete FDA information sheet can be accessed at:

"http://www.fda.gov/cder/drug/InfoSheets/HCP/haloperidol.htm"