The U.S. Food and Drug Administration now requires new labeling on Johnson & Johnson's Haldol (generic: Haloperidol) noting QT prolongation and Torsades de Pointes as serious side effects. A number of case reports indicated sudden death, most where patients took the drug at higher doses than recommended, or were given it intravenously.

According to the FDA's website, the warnings note that:

• Higher doses and intravenous administration of haloperidol appear to be associated with a higher risk...