FDA issues haloperidol cardiovascular prescribing update

The FDA has updated the warnings section of the prescribing information for Johnson & Johnson's (J&J) Haldol (haloperidol) treatment for psychosis.

The label 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. Both cases refer to different types of ventricular tachycardia, where heart beat speed increases.

Although injectable haloperidol is only approved by the FDA for intramuscular injection, there is strong evidence that the intravenous administration of haloperidol is a relatively common off-label clinical practice.

There have been 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.

According to Reuters, J&J's stock fell USD 0.26 to rest at USD 62.94 in 17 September afternoon trading on the New York Stock Exchange composite.

Atypical antipsychotics have replaced Haldol and posted sales of USD 11.5bn in 2006, according to IMS Health data. J&J does not routinely release Haldol sales figures.