* LABELING OF PD DRUG SOFTENED

June 1, 2007

The FDA has approved less restrictive labeling for the catechol-O-methyltransferase inhibitor tolcapone (Tasmar). The agent has been useful in increasing "on" time in patients with Parkinson disease (PD) when used as an adjunct to levodopa/ carbidopa therapy. Tolcapone has been subject to restrictive labeling because 3 reports of fulminant hepatic failure, resulting in death, were traced to its use.

The FDA has approved less restrictive labeling for the catechol-O-methyltransferase inhibitor tolcapone (Tasmar). The agent has been useful in increasing "on" time in patients with Parkinson disease (PD) when used as an adjunct to levodopa/ carbidopa therapy. Tolcapone has been subject to restrictive labeling because 3 reports of fulminant hepatic failure, resulting in death, were traced to its use.

The FDA deemed that it had been too restrictive in its labeling requirements and agreed that the patient consent form that accompanies the product could be replaced with a patient acknowledgment form that the manufacturer, Valeant Pharmaceuticals, feels is more evenhanded and provides a better jumping-off point for physician-patient discussion about the risks and benefits of the drug.

--Dee Rapposelli