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.