FDA and the maker of Tasmar (tolcapone), a drug for treating Parkinson's disease, have warned doctors about three fatal liver injuries associated with the drug and have recommended significant changes in how it is used.
Worldwide, about 60,000 patients have taken Tasmar, a drug approved in 1997 to augment treatment with two other Parkinson's drugs, levadopa and carbidopa. The three deaths amount to a rate of about one reported death for every 20,000 patients using the drug.
Last November, Tasmar manufacturer Hoffmann-La Roche Inc. alerted doctors that the drug's labeling had changed to limit its use to patients who do not have severe movement abnormalities and who do not respond to or who are not appropriate candidates for other available treatments.
The new warning calls for liver monitoring every two weeks, more frequently than previously recommended. Doctors also should advise patients to monitor themselves for signs of liver disease such as jaundice, fatigue, or loss of appetite. If patients fail to show substantial benefit within the first three weeks of treatment, they should be withdrawn from the drug.
FDA emphasizes that patients should not stop taking Tasmar without first speaking to their doctors. Abrupt withdrawal or reduction in dose can lead to a return of symptoms or other, more serious, complications. All cases of serious liver injury occurring in Parkinson's patients, whether on Tasmar or another drug, should be reported to FDA's MedWatch program, or to Roche Laboratories at 1-800-526-6367.
(For more information about Parkinson's, see "Parkinson's Disease: New Treatments Slow Onslaught of Symptoms" in the July-August 1998 FDA Consumer.)
COPYRIGHT 1999 U.S. Government Printing Office
COPYRIGHT 2004 Gale Group
Contact
Home
A
Oxytetracycline