E-DRUG: U.S. FDA's warning for new Parkinson's drug
---------------------------------------------------
T98-81
November 16, 1998
NEW WARNINGS FOR PARKINSON'S DRUG, TASMAR
FDA and Hoffmann-La Roche Inc., the manufacturer of the drug Tasmar
(tolcapone) for patients with Parkinson's Disease, are advising doctors
about reports of a new finding of fatal liver injury associated with use
of the drug, and recommending significant changes in how it is used.
Because of these reports, Tasmar's labeling now states that the drug
should be reserved for use only in patients who do not have severe
movement abnormalities and who don't respond to or who are not
appropriate candidates for other available treatments.
Hoffmann-La Roche is issuing a "Dear Doctor" letter alerting physicians
to the labeling changes and reports of three deaths from acute, severe
(fulminant) liver failure.
Although a precise rate of these deaths is not known, about 60,000
patients have been given Tasmar worldwide, indicating a rate of
approximately one reported death for every 20,000 patients using the
drug. FDA and Hoffmann-La Roche are asking health professionals to
exercise additional caution in using the product and to report any
additional cases of liver injury.
Tasmar was originally approved as an adjunct to levodopa and carbidopa
for the treatment of the signs and symptoms of idiopathic Parkinson's
disease.
FDA advises doctors to follow instructions in the new boxed warning in
the drug's label. The warning calls for increased liver monitoring
(every two weeks) if a prescriber elects to treat patients with Tasmar.
Doctors should also advise their patients to self-monitor for classical
signs of liver disease such as jaundice and nonspecific ones such as
fatigue and loss of appetite. The boxed warning also advises that in
light of the severe liver toxicity, if a patient fails to show a
substantial clinical benefit within the initial 3 weeks of treatment,
he/she should be withdrawn from the drug.
In addition, the new labeling includes an informed consent document that
physicians are advised to use when prescribing Tasmar to patients to
help assure full understanding by patients of the potential benefits and
risks of this product.
Patients are advised not to stop taking Tasmar without first speaking to
their doctor or health care provider. Abrupt withdrawal or reduction in
dose can lead to a return of symptoms or to other more serious
complications.
FDA is closely monitoring this matter and may take further action if new
reports show that the liver injury rate proves greater than it now
appears.
FDA further requests that all cases of serious liver injury occurring in
Parkinson's patients whether on Tasmar or any other drug be reported to
the agency through MEDWATCH. Reports to Medwatch should be made by phone
to 1-800-FDA-1088, by fax to 1-800-FDA-0178, by mail to MEDWATCH HF-2,
FDA, 5600 Fishers Lane, Rockville, MD 20857. Reports can also be made
through the MEDWATCH website at www.FDA.gov/medwatch. Health
professionals may also contact Roche Laboratories at 1-800-526-6367 to
report adverse events for Tasmar or for further information about
labeling changes. Roche Labs is based in Nutley, New Jersey.
--
Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'.
Mail administrative requests to `majordomo@usa.healthnet.org'.
For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'.