Cyproterone Risks Resurface

Concerns over the safety of cyproterone acetate-based drugs, which led to the temporary suspension (now revoked) of two of Schering AG's drugs, Androcur 10 and Diane 35, in Germany (Marketletters passim), have resurfaced after reports of three cases of liver cancer among high-dose cyproterone users in Japan (Lancet December 3).

Other possible causes of liver cancer, including hepatitis B virus surface antigen and chronic hepatitis, were ruled out by the researchers, from the National Cancer Center Research Institute in Tokyo, Japan. The three patients were all suffering from precocious puberty (two as a result of Turner's syndrome), and received doses of the drug ranging from 100-300mg/day.

The researchers have organised a study group to survey cyproterone users in Japan, and have registered nearly 2,000 patients to date. Alpha-fetoprotein testing and ultrasonography will be used to clarify the size of the risk for hepatic tumors.