Flutamide - Warnings and Precautions
The following warnings and precautions are taken directly from the US FDA-approved drug label for Flutamide. This is the same information dispensing pharmacists read.
\u26a0\ufe0f Boxed Warning (Highest FDA Alert)
WARNINGS Hepatic Injury There have been postmarketing reports of hospitalization and rarely death due to liver failure in patients taking Eulexin ® . 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 discontinuation of therapy in some patients. Approximately half of the reported cases occurred within the initial 3 months of treatment with Eulexin ® . Serum transaminase levels should be measured prior to starting treatment with Eulexin ® . Eulexin ® 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 signs and symptoms suggestive of liver dysfunction, e.g., nausea, vomiting, abdominal pain, fatigue, anorexia, "flu-like" symptoms, hyperbilirubinuria, 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, Eulexin ® should be immediately discontinued with close follow-up of liver function tests until resolution.
WARNINGS Hepatic Injury SEE BOXED WARNINGS Use in Women Eulexin ® capsules are for use only in men.
This product has no indication for women and should not be used in this population, particularly for nonserious or nonlife-threatening conditions.
Fetal toxicity Eulexin ® may cause fetal harm when administered to a pregnant woman (see Pregnancy ).
Aniline toxicity One metabolite of Eulexin ® is 4-nitro-3-fluoro-methylaniline.
Several toxicities consistent with aniline exposure, including methemoglobinemia, hemolytic anemia and cholestatic jaundice have been observed in both animals and humans after Eulexin ® administration.
In patients susceptible to aniline toxicity (e.g. persons with glucose-6-phosphate dehydrogenase deficiency, hemoglobin M disease and smokers), monitoring of methemoglobin levels should be considered.
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