Mellaril®

A boxed WARNING has been added to prominently advise clinicians that Mellaril® (thioridazine HCl) 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 arrhythmias and sudden death.

Mellaril® is now indicated only for schizophrenic patients who fail to show an acceptable response to adequate courses of treatment with other antipsychotic drugs, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects. Mellaril® has not been systematically evaluated in controlled trials in treatment refractory schizophrenic patients and its efficacy in such patients is unknown.

Mellaril® is now contraindicated with certain other drugs, including fluvoxamine, propranolol, pindolol, any drug that inhibits the cytochrome P450 2D6 isozyme, e.g., fluoxetine and paroxetine, and agents known to prolong the QTc interval; Mellaril® is also contraindicated in patients known to have reduced levels of the cytochrome P450 2D6 isozyme as well as in patients with congenital long QT syndrome or a history of cardiac arrhythmias.

Source: fda.gov

If you or a loved one has been harmed by Mellaril®, you may want to contact a Mellaril® attorney for more information.