ROCKVILLE, Md., Nov. 18 /PRNewswire/ -- FDA and Hoffman-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.
Hoffman-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 Hoffman-
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initial 3 weeks of treatment, he/she should be withdrawn from the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 http://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.
Consumer Inquiries: 888-INFO-FDA
SOURCE Food and Drug Administration
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