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Flutamide hepatotoxicity

D K Wysowski1, J L Fourcroy

  • 1Division of Epidemiology and Surveillance, Food and Drug Administration, Rockville, Maryland, USA.

The Journal of Urology
|January 1, 1996
PubMed
Summary

Flutamide (a drug) can cause severe liver damage (hepatotoxicity), leading to hospitalization or death in some patients. Monitoring liver enzymes and reporting symptoms like jaundice is crucial during treatment.

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Area of Science:

  • Hepatology
  • Clinical Pharmacology
  • Drug Safety

Background:

  • Flutamide is a nonsteroidal antiandrogen used in prostate cancer treatment.
  • Hepatotoxicity is a known, albeit rare, adverse effect of flutamide therapy.

Purpose of the Study:

  • To compare observed and expected reporting rates of hepatotoxicity in patients using flutamide.
  • To assess the risk of severe liver injury associated with flutamide treatment.

Main Methods:

  • Analysis of case series reported to the FDA's MedWatch Spontaneous Reporting System.
  • Comparison of flutamide-associated hepatotoxicity rates with literature data for acute idiopathic hepatitis hospitalizations.

Main Results:

  • Between 1989 and 1994, 20 deaths and 26 hospitalizations due to flutamide hepatotoxicity were reported.
  • The observed rate of hepatotoxicity (approx. 3 per 10,000 users) was significantly higher than expected rates for liver injury in the elderly male population.
  • Autopsies confirmed severe hepatic necrosis in six cases.

Conclusions:

  • Flutamide is a potent hepatotoxin in susceptible individuals.
  • Routine monitoring of aminotransferase levels and patient education on early warning signs are recommended.
  • Prompt discontinuation of flutamide is advised upon symptom onset to prevent severe liver injury.

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