The following is excerpted verbatim from the manufacturer’s package insert for Eulexin, a brandof flutamide, a hormone-inhibiting drug often prescribed to prostate cancer patients:
…The inactive ingredients for EULEXIN Capsules include: com starch, lactose, magnesium stearate, povidone, and sodium lauryl sulfate. Gelatin capsule shells may contain methylparaben, propylparaben, butylparaben and the following dye systems: FD & C Blue 1, FD & C Yellow 6 and either FD & C Red 3 or FD & C Red 40 plus D & C Yellow 10 with titanium dioxide and other inactive ingredients.
…EULEXIN Capsules are contraindicated in patients who are hypersensitive to flutamide or any component of this preparation.
…Hepatic Injury: Since transaminase abnormalities, cholestatic jaundice, hepatic necrosis and hepatic encephalopathy have been reported with the use of flutamide, periodic liver function tests should be considered…Appropriate laboratory testing should be done at the first symptom/sign of liver dysfunction (e.g., pruritus, dark urine, persistent anorexia, jaundice, right upper quadrant tenderness or unexplained “flu-like” symptoms). If the patient has jaundice or laboratoy evidence of liver injury, in the absence of biopsy-confffmed liver metastases, EULEXIN therapy should be discontinued or the dosage reduced. The hepatic injury is usually reversible after discontinuation of therapy, and in some patients, after dosage reduction. However, there have been reports of death (emphasis added) following severe hepatic injury associated with the use of flutamide.
… No carcinogenicity studies were performed with flutamide. However, daily administration of flutamide to rats for 52 weeks at doses of 30, 90 or 180 mg/kg/ day (approximately 3,8 or 17 times the human dose), produced testicular interstitial cell adenomas at all doses.
…In addition, the following spontaneous adverse experiences have been reported during the marketing of flutamide: hemolytic anemia, macrocytic anemia, methemoglobinemia, photosensitivity reactions (including erythema, ulceration, bullous eruptions, and epidermal necrolysis) and urine discoloration. The urine was noted to change to an amber or yellow-green appearance which can be attributed to the flutamide and/or its metabolites. Also reported were cholestatic jaundice, hepatic encephalopathy, and hepatic necrosis.
