CLDF Title
Home | Contact Us | Bookmark
HBV HE HCC HCV
About CLDF Centers of Educational Expertise  
CME Dinner Meetings Telewebs Webcasts Slide Library Abstract Library Conference Highlights
 
Back  
 
Reuters Health Information (2004-04-22): CPMP lifts ban on Roche's Parkinson's drug Tasmar

Regulatory

CPMP lifts ban on Roche's Parkinson's drug Tasmar

Last Updated: 2004-04-22 14:55:20 -0400 (Reuters Health)

LONDON (Agence de Presse Medicale for Reuters Health) - The European Medicine Evaluation Agency's scientific committee on Thursday recommended allowing Roche's Parkinson's disease drug Tasmar (tolcapone) back on the market in Europe.

Marketing authorisation was suspended throughout the EU in November 1998, soon after launch, because of concerns about hepatotoxicity and neuroleptic malignant syndrome. Three patients had died of liver failure and several others were seriously affected.

However the agency said in a statement: "On the basis of new data, including a clinical trial conducted by the marketing authorisation holder during the period of the suspension, the Committee has recommended more stringent liver function monitoring and monitoring for signs and symptoms of liver disease."

"The CPMP also recommends that Tasmar should be contra-indicated for patients with certain medical histories, including liver disease and neuroleptic malignant syndrome."

Tasmar has remained on the market in the United States though its label includes a warning to doctors that acute, fatal liver failure can be a rare side effect and cites a need for regular patient monitoring.

Before marketing authorisation was suspended in Europe, it had been prescribed to 60,000 patients worldwide, of which 40% were in Europe.

 
 
 
 
                 
 
HBV
Webcasts
Slide Library
Abstract Library
 
HE
CME Dinner Meeting
Webcasts
Slide Library
Abstract Library
 
HCC
Slide Library
Abstract Library
 
 
HCV
Webcasts
Slide Library
Abstract Library
 
CLDF Follow Us
   
 
About CLDF
Mission Statement
Board of Trustees
Board of Advisors
CLDF Supporters
 
Other Resources
Liver News Library
Journal Abstracts
Hep C Link to Care
 
Centers of
Educational Expertise
Regional Map
     
   
  The Chronic Liver Disease Foundation is a non-profit organization with content developed specifically for healthcare professionals.
© Copyright 2012-2014 Chronic Liver Disease Foundation. All rights reserved. This site is maintained as an educational resource for US healthcare providers only.
Use of this Web site is governed by the Chronic Liver Disease Foundation terms of use and privacy statement.