E-DRUG: Flutamide and liver toxicity
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A Dear Health Professional has been issued today in the U.S.A. by the
manufacturers of the prostate cancer drug flutamide about recent changes
in the product labeling. The changes include a boxed warning of liver
toxicity as well as monitoring requirements for hepatic injury. The
letter has been reproduced below:
IMPORTANT PRESCRIBING INFORMATION
Dear Health Professional:
This letter is to inform you about recent changes in the product
labeling for EULEXIN (flutamide capsules). The changes include a boxed
warning of liver toxicity in patients taking EULEXIN as well as
monitoring requirements for hepatic injury. The new labeling includes:
WARNINGS
Hepatic injury
There have been post-marketing reports of hospitalization and rarely
death due to liver failure in patients taking flutamide. Evidence of
hepatic injury included elevated serum transaminase levels, jaundice,
hepatic encephalopathy and death related to acute hepatic failure. The
hepatic injury was reversible after prompt discontinuation of therapy in
some patients. Approximately half of the reported cases occurred within
the initial 3 months of treatment with flutamide.
Serum transaminase levels should be measured prior to starting treatment
with flutamide. Flutamide is not recommended in patients whose ALT
values exceed twice the upper limit of normal. Serum transaminase levels
should then be measured monthly for the first 4 months of therapy, and
periodically thereafter. Liver function tests also should be obtained at
the first sign and symptoms suggestive of liver dysfunction, e.g.,
nausea, vomiting, abdominal pain, fatigue, anorexia "flu-like" symptoms,
hyper bilirubinuria, jaundice or right upper quadrant tenderness. If at
any time, a patient has jaundice, or their ALT rises above 2 times the
upper limit of normal, flutamide should be immediately discontinued with
close follow-up of liver function tests until resolution.
Contraindication
The revised labeling contains a contraindication for the use of EULEXIN
in patients with severe hepatic impairment.
EULEXIN has not been studied in women and is not indicated for this
population, particularly for non-serious or non-threatening conditions.
This information is provided to you by Schering Corporation as part of
our commitment to provide you with the most current product information
available. We hope that this information will help you manage your
patients who are currently receiving EULEXIN, as well as those who will
benefit from EULEXIN in the future. You can further our understanding of
adverse events by reporting all cases to Schering Corporation at
1-800-437-4089 or to the FDA MedWatch program by phone 1-800-FDA-1088,
by fax 1-800-0178, by mail (using postage-paid form) MedWatch, HF-2,
FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or via
www.FDA.gov/medwatch.
Additional questions concerning EULEXIN should be directed to Schering's
Drug Information Services at 1-800-526-4099.
Thank you for your continuing support.
Sincerely,
Schering Corporation
2000 Galloping Hill Road
Bldg. K5-2
Kenilworth, NJ 07033, USA
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