Haldol

The FDA and Johnson & Johnson have alerted healthcare professionals to changes in the prescribing information for antipsychotic drug Haldol (Haloperidol).

New warnings address the risk of cardiovascular events including sudden death, QT prolongation and Torsades de Pointes (TdP) in patients treated with Haldol intravenously or at higher than recommended doses. Intravenous administration of Haldol is an off-label use not currently approved by the FDA.

Torsades de Pointes (TdP) is a rare ventricular arrhythmia associated with a prolonged QT interval. A QT interval is the duration of electrical activity controlling contraction of the heart muscle. Prolonging it can cause life-threatening arrhythmias, cardiac arrest, and sudden death.

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

Haldol Linked to Tardive Dyskinesia

Haldol use has also been linked to Tardive Dyskinesia, a serious neurological condition characterized by persistent involuntary movements of the tongue, face, mouth or jaw (e.g., protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements), sometimes accompanied by involuntary movements of the arms, legs, and trunk. 

Do not change medications without consulting a doctor.

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