7/15/2000 – FDA Warning Comes 40 Years Too Late on Mellaril

We are grateful to our e-group member, Martin Hirschfeld,
and also to Vera Hassner Sharav, President, CIRCARE:
Citizens for Responsible Care & Research, for forwarding
this information to us.
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.

Dr. Ann BlakeTracy
________________________

New Labeling For Novartis’ Mellaril Reflects Restricted Use

http://www.medscape.com/reuters/prof/2000/07/07.13/20000713rglt002.html
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 [Luvox] 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.
=================================================================
New Labeling For Novartis’ Mellaril Reflects Restricted Use

www.medscape.com/reuters/prof/2000/07/07.13/20000713rglt002.html
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.

723 total views, no views today