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Carole- Thanks for typing the warning. I tried to use ocr via Dale but he quality degraded so much through repeated faxing of small type that a lot of it came out gibberish. Sorry Dale- I tried. Charlie "Cassidy, Carole" wrote: > 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 treatment should be withdrawn from TASMAR.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]