Novartis Mellaril Shifted To Second-Line Anti-Psychotic With QTc Black Box
Executive Summary
Novartis Mellaril's black box warning that thioridazine causes QTc prolongation will shift it to a second-line anti-psychotic therapy.
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Novartis/Boehringer-Ingelheim Serentil
Boxed warning about potential QTc prolongation associated with antipsychotic mesoridazine is added to labeling, and product is restricted to second-line status. The change is similar to a July relabeling for Novartis' chemically-related product Mellaril (1"The Pink Sheet" July 17, p. 12). Mesoridazine is a Mellaril (thioridazine) metabolite