Novartis Mellaril
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Thioridazine labeling is revised to add black box warning on QTc prolongation and to shift the drug to second-line use in patients refractory or intolerant to other anti-psychotics. The warning states that Mellaril has been shown to "prolong the QTc interval in a dose-related manner, and drugs with this potential, including Mellaril, have been associated with torsade de pointes-type arrhythmia and death," according to a July 7 Novartis "Dear Doctor" letter. The agent also added contraindications for use with several drugs, including fluvoxamine, propranolol, pindolol, fluoxetine and paroxetine. Labeling changes are based on FDA review of three published studie