CSM Clamps Down On Cyproterone Acetate..

The UK Department of Health's Committee on Safety of Medicines has recommended restrictions on the use of cyproterone acetate (Schering Health Care's Cyprostat) for treating prostate cancer. The move follows questions about the hepatotoxicity of the compound raised by the German regulatory authorities and the European Union's Committee for Proprietary Medicinal Products (Marketletters passim).

The CSM recommends that the use of cyproterone should be restricted to short courses to cover the testosterone flare associated with LHRH agonists, the treatment of hot flushes after orchidectomy or LHRH agonists, or treatment of patients who are intolerant to or have not responded to other therapies. The CSM also advises that liver function tests should be conducted before treatment and when patient symptoms are suggestive of some hepatic impairment.

The agency notes in its Current Problems bulletin that it has received 96 reports, 33 of which were fatal, regarding hepatic reactions to cyproterone. 91 of the cases occurred in elderly men aged 60-90 years with prostatic cancer. The CSM notes that the average daily dose in these cases was 300mg, with symptoms of hepatic impairment emerging around five months after initiating treatment.