July 14

New FDA Warning about fatal risk linked to Melaril after 40 years

July 14, 2000.

New FDA Warning about fatal risk linked to Melaril after 40 years!


For 40 years schizophrenia patients have been prescribed Mellaril, a drug that the FDA finally acknowledges causes sudden death due to cardiac arrest! Why did it take the FDA 40 years before it sent warning letters to doctors and pharmacists ? HOW MANY PATIENTS DIED BECAUSE THE FDA DID NOTHING TO ALERT THEM? Was the Mellaril fatal risk reported to the FDA’s Adverse Drug Reaction (ADR) physician hotline? Is the FDA hotline accessible to the public for its protection? How many reports of potentially fatal drug reactions does it take before the FDA informs physicians and the public about the risk?


Dr. Ann Blake Tracy provides additional warnings about dangerous drug side-effects. AFTER 40 YEARS OF USE – the FDA has put new restrictions on the use of the antipsychotic, Mellaril. Obviously for many patients this strong warning about life threatening side effects has come 40 years too late!

How many patients would still be alive had the warning come when it should have – 40 years ago? This should cause us to ask just how many more drugs are as damaging or even more dangerous, that we have yet to be warned by the FDA of their dangers?

For those using SSRIs, note that an additional warning of contraintication is issued to those using Luvox or another drug often given in conjunction with SSRIs, propranolol. Considering the accumulation rate of SSRIs, including Luvox, the contraindication for Mellaril should include anyone who has been on Luvox in the recent past as well. And because psychosis is listed as a "frequent" side effect of Luvox, the prescribing of an antipsychotic such as Mellaril could be a fairly common practice threatening the lives of many.


New Labeling For Novartis’ Mellaril Reflects Restricted Use


NEW YORK, Jul 13 (Reuters Health) – The US Food and Drug Administration (FDA) has asked Novartis to update the labeling for its antipsychotic drug Mellaril (thioridazine) to warn of potentially life-threatening side effects, the company said on Wednesday.

Thioridazine has been shown to prolong patients’ QTc interval, an electrocardiogram measurement reflecting the refractory period of the heart, which can lead to the potentially fatal ventricular tachycardia known as torsades de pointes and sudden death, according to the FDA.

As a result, Mellaril is now indicated only for patients with schizophrenia who either cannot tolerate other antipsychotic drugs or who fail to respond to them, the company said.

In addition to changing Mellaril’s label, Novartis will send letters to about 360,000 US doctors and 60,000 pharmacies apprising them of the FDA’s new position on the drug, and asking them to share the information with their patients.

The letters advise that “switching to a different antipsychotic agent should be considered.” Mellaril, which was approved in 1959, has already been eclipsed by newer therapies for many patients, a Novartis spokesperson told Reuters Health. While the new warnings threaten to slash sales of the drug even further, “in the short term, we won’t be discontinuing it,” he said. The product is also sold by a handful of generic manufacturers, including Geneva and Mylan.

Novartis’ letter to physicians stresses that, in light of the new information about Mellaril, the drug is “now contraindicated with certain other drugs,” including the antidepressant fluvoxamine and the beta-blocker propranolol, and is considered inappropriate for patients with a history of cardiac arrhythmias and certain other conditions.

Before being treated with Mellaril, patients should be evaluated with a baseline ECG and should have their serum potassium levels measured, the letter adds, noting that monitoring should be continued throughout the treatment.

The letter points out that Boehringer Ingelheim’s Serentil (mesoridazine), which is chemically related to thioridazine, “also appears to have the capacity to prolong the QTc interval.” Boehringer Ingelheim and the FDA did not respond to telephone calls seeking comment.

Copyright © 2000 Reuters Ltd. All rights reserved.

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