 |
 |
Dale: This is very important and I'm glad to see you following up. I have a copy of the warning and will use the old-fashioned (i.e., typing) method to give you all the gist of the warning (not the full text) "Dear Healthcare Professional: "Hoffman-La Roche Inc. would like to advise you of new warnings in the labeling for Tasmar (tolcapone) Tablets, a COMT inhibitor that is indicated as an adjunct to levodopa and carbidopa for the treatment of the signs and symptoms of Parkinson's Disease. These new warnings pertain to reports of severe, potentially life threatening cases of severe hepatocellular injury, incl uding 3 deaths from acute fulminant liver failure, that have been reported in association with the use of Tasmar.... "Because of the risk of potentially fatal, acute fulminanat liver failure, TASMAR (tolcapone) should ordinarily be used in patients with Parkinson's disease on l-dopa/carbidopa who are experiencing symptom fluctuations and are not responding satisfactorily to or are not appropriate candidates for other adjunctive therapies. the revisions to the labeling, made in consultation with the US Food and Drug Administration, reflect additional information obtained through postmarketing experience in an estimated 60,000 patients providing approximately 40,000 patient-years of worldwide use. The incidence of hepatocellular injury may be 10- to 100-fold higher than the background incidence in the general population.... "Because of the risk of liver injury and because TASMAR, when it is effective, provides an observable symptomatic benefit, the patient who fails to show substantial clinical benefit within 3 weeks of initiation of treatment should be withdrawn from TASMAR. "TASMAR therapy should not be initiated if the patient exhibits clinical evidence of liver disease or two SGPT/ALT values greater than the upper limit of normal. Patients with severe dyskinesia or dystonia should be treated with caution... "A prescriber who elects to use TASMAR in the face of increased risk of liver injury is strongly advised to monitor patients for evidence of emergent liver injury. Patients should be advised of the need for self-monitoring for both the classical signs of liver disease (e.g., clay colored stools, jaundice) and the nonspecific ones (e.g., fatigue, loss of appetite, lethargy)." There is more, but this should give everyone the idea. Please excuse typing errors... Carole -----Original Message----- From: Dale Severance [mailto:[log in to unmask]] Sent: Monday, November 16, 1998 2:51 PM To: Multiple recipients of list PARKINSN Subject: important new tasmar warning i JUST RECEIVED A CALL FROM MY MOVEMENT DISORDER SPECIALIST. hE SAYS THAT A NEW WARNING ABOUT tASMAR HAS BEEN ISSUED. hE PLANS TO TAKE ALL PATIENTS OFF THE DRUG AS SOON AS POSSIBLE. He asked me to activate the SG calling chain and have everyone call him tomorrow mi\orning. He is trying to get a hard copy of the warning and when he does he will fax it to me and I will convey the message to you. Fax coming thru will be right back with message if this is the doctor's fax. Dale Severance [log in to unmask]