I Took this press release directly from the FDA WEB page for all
interested. I suggest to call your doctor today but do not stop the drug
until you speak with the prescribing physician.
Charlie
FDA
TALK PAPER
Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel
in responding with consistency and
accuracy to questions from the public on subjects of current interest.
Talk Papers are subject to change as more
information becomes available.
T98-81 Print Media: 301-827-6242
November 16, 1998 Broadcast Media: 301-827-3434
Consumer Inquiries: 888-INFO-FDA
NEW WARNINGS FOR PARKINSON'S DRUG, TASMAR
FDA and Hoffmann-La Roche Inc., the manufacturer of the drug Tasmar> 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.
####
