Roche Media Release
Basel, November 17, 1998
Tasmar® label change in the US - Suspension in the European Union
Evolving safety information about the anti-parkinson drug Tasmar®
(tolcapone) has led Roche to revise the recommendations
to physicians on the appropriate use of the drug. These changes reflect
additional information obtained through post-marketing
experience in approximately 100'000 patients worldwide.
After careful review of all available information and in consultation
with outside medical experts, Roche is of the opinion that for
a restricted group of patients suffering from Parkinson's Disease, the
addition of Tasmar to standard therapy is providing a
clinically significant benefit that outweighs the risks. Cases of rare
and unexpected adverse events, including three fatal cases of
unpredictable, fulminant hepatitis, have been reported.
Parkinson's Disease is a chronic, increasingly debilitating disease
afflicting almost 2 million people for whom only a limited
number of treatments are available.
In consultation with the Food and Drug Administration FDA, Roche is
issuing in the United States a revised label, indicating that
the drug should be used as an adjunctive therapy in patients with
Parkinson's Disease who do not respond satisfactorily to other
therapies. This and other important safety information are being
communicated immediately to all physicians.
In the European Union, the Commission has initiated the procedure asking
member states to suspend the use of Tasmar as of
Tuesday, 17th November 1998. Roche's principle concern is to implement
the Commission's decision with the patients' interest
in mind. Roche and regulatory authorities in other countries are working
closely to ensure that the revised recommendations for
the appropriate use of Tasmar are implemented.
Patients taking Tasmar should consult their physicians and should not
precipitately stop treatment, since inappropriate change in
therapy might trigger serious adverse events. Roche is informing
physicians and other health care professionals accordingly.
Tasmar (tolcapone), a COMT inhibitor used in combination with levodopa
preparations for the treatment of Parkinson's
Disease, has been first launched in August 1997 and is currently
available in 38 countries.
--
Judith Richards, London, Ontario, Canada
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