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FDA posts safety alerts, public health advisories, press releases and other notices from companies as a service to health professionals, consumers and other interested parties. Although FDA approves medical products, FDA does not endorse either the product or the company.
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
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