Tasmar Suspended In Europe; Label Change Only In USA

Roche's Tasmar (tolcapone) has been suspended from sale in the EuropeanUnion after a review of post-marketing experience in approximately 100,000 patients resulted in concerns regarding adverse events. Meanwhile, the US Food and Drug Administration has stopped short of banning the drug, but has mandated changes to its labeling to ensure its safe use.

The European Commission asked its member states to suspend use of Tasmar with effect from November 17. In the USA, Roche has issued a revised label in consultation with the FDA, which now states that the drug should be used as adjunctive therapy in patients with Parkinson's disease but only in those who have not had an adequate response to other therapies.

Roche said it is consulting with regulatory authorities in the other countries in which Tasmar is marketed to revise recommendations for its appropriate use. Roche president Franz Humer commented that he hoped other authorities would take a line similar to the FDA, as the company believes that Tasmar's benefits outweigh its risks, at least in some patients with Parkinson's disease.