| |
Unique Clozaril National Registry Paramount to Patient Safety
BASEL, Switzerland, Dec. 1 /PRNewswire/ -- In light of the FDA's
decision to approve a generic version of Clozaril(R) by IVAX
Corporation, Novartis Pharmaceuticals Corporation, manufacturer of
Clozaril tablets, reemphasized today its commitment to the safe and
effective treatment of therapy-resistant schizophrenia.
''Clozaril is a uniquely effective treatment for severely ill patients
with schizophrenia who have failed to respond to other antipsychotic
therapies,'' said Wayne Yetter, CEO of Novartis Pharmaceuticals
Corporation. ''In addition, it is the only antipsychotic that is not
associated with a significantly increased risk of parkinsonian symptoms
or tardive dyskinesia.''
In clinical trials conducted prior to approval of Clozaril in the U.S.,
the use of Clozaril was associated with a 1-2% incidence of
agranulocytosis, a potentially fatal decrease in the white blood cell
count. In an effort to manage this side effect, discussions with the FDA
were held that led to the introduction of Clozaril in conjunction with a
comprehensive patient monitoring system. This program, the Clozaril
National Registry(R)(CNR), is a unique patient monitoring system which
mandates weekly blood sampling from patients receiving treatment based
upon a ''no blood, no drug'' policy.
The use of the CNR system in over 165,000 U.S. patients over the past
seven years has resulted in a documented reduction of agranulocytosis
from the initially reported incidence of 1-2% to a current rate of
0.38%. Largely due to the success of this patient monitoring system, the
FDA Advisory Committee met in July 1997 and unanimously recommended a
reduction in the frequency of monitoring to bi-weekly after six months.
Yetter further commented, ''Novartis attributes a reduction in
agranulocytosis and improved safety for patients to the unique features
of the CNR.''
In addition to monitoring patients who receive Clozaril, the registry
fulfills another vital function, it identifies patients who are at an
unacceptably high risk for developing agranulocytosis and, therefore,
should never be re-exposed to treatment with Clozaril. Novartis would
like to assure consumers of Clozaril that it will continue to insure the
high quality of the monitoring provided by the CNR.
Novartis will cooperate with the FDA and other manufacturers who are
equally committed to meeting the high standards of the CNR to insure
patient safety.
Novartis is a world leader in Life Sciences, with its core businesses in
Healthcare, Agribusiness and Nutrition. In 1996, Novartis achieved group
sales of 27.6 billion Swiss francs, of which 16.3 billion were in
Healthcare, 7.6 billion in Agribusiness and 3.7 billion in Nutrition,
and invested more than 3 billion Swiss francs in research and
development. Headquartered in Basel, Switzerland, Novartis employs
88,000 people in more than 100 countries around the world.
SOURCE: Novartis Pharmaceuticals Corporation
------------------------------------------------------------------------
More Quotes and News:Novartis AG (OTC BB:NVTSY - news)Related News
Categories: health care
------------------------------------------------------------------------
Help
------------------------------------------------------------------------
Copyright c 1997 PRNewswire. All rights reserved. Republication or
redistribution of PRNewswire content is expressly prohibited without the
prior written consent of PRNewswire. PRNewswire shall not be liable for
any errors or delays in the content, or for any actions taken in
reliance thereon.
Important Disclaimers and Legal Information
Questions or Comments? |
|
