E-DRUG: Parkinson's Drug Suspended in Europe
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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.
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