Mellaril

Mellaril is an antipsychotic drug manufactured by Novartis Pharmaceuticals for the management of schizophrenic patients failing to adequately respond to treatment using alternate antipsychotic drugs. On July 7, 2000, doctors and pharmacists were alerted of the Mellaril safety warnings that was being added to Mellaril labeling and package inserts. The new Mellaril warnings were included in extensive safety warnings, which was found in a boxed warning, the professional product labeling, and package insert of Mellaril.

The Mellaril boxed warning was to appear at the top of the Mellaril labeling to better caution QTc interval prolongation that will sometimes lead to a heart rhythm disturbance or cardiac arrhythmia (torsade de pointes), and sudden death. The addition of the Mellaril boxed warning was a result of the findings based mainly on the FDA’s review of three published studies. One Mellaril study was published in the 1991 journal Clinical Pharmacology and Therapeutics, the second study was published in 1996 also in the Clinical Pharmacology and Therapeutics, and the third study was published in the 1999 Journal of Clinical Psychopharmacology.

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