Published: February 2010

Flutamide case report: Serious hepatic reaction

Prescriber Update 31(1): 1
February 2010

Flutamide has potent anti-androgenic effects and is indicated in New Zealand for the treatment of advanced prostate cancer1. Over recent years it has also been used to treat disorders associated with hyperandrogenism in females, an "off-label" use.

CARM has received a report of a serious hepatic adverse reaction that occurred in a female following the use of flutamide. The report describes subacute hepatic failure progressing to encephalopathy. The duration of flutamide use to the onset of the reaction was approximately three months. Hepatic function deteriorated irreversibly. The patient was also taking concomitant medicines at the time of the adverse reaction, however these were previously well tolerated.

Although it is not possible to conclusively state that flutamide was the causal agent, this report serves as a timely reminder of the potential for serious hepatic reactions associated with the use of this medicine.

The CARM database contains 11 reports of hepatic reactions associated with the use of flutamide in New Zealand; all reports concern males who were prescribed flutamide for prostate cancer or metastases. The literature also contains references to cases involving serious hepatic reactions following the use of flutamide2.

The flutamide data sheets published on Medsafe’s website contain specific warnings and advice about its use in patients with existing hepatic injury. The data sheets also recommend that periodic liver function tests are performed in all patients. Treatment should be discontinued if the patient develops jaundice or if serum transaminases rise to two to three times the upper limit of normal.1

Prescribers are also reminded to advise patients of the possibility of hepatic dysfunction when prescribing flutamide and to consult a healthcare professional if symptoms of hepatic dysfunction occur.

  1. Mylan New Zealand Limited. May 2009. Flutamin (flutamide data sheet)
  2. Drugdex (database on the Internet). Thomson Reuters Healthcare. c 1974-2009, Drugdex Evaluations – Flutamide (cited 3 December 2009).