Schering AG Defends CPA In Germany

Schering AG has issued a statement to the federal drug institute in Germany, the BAM, saying that its steroidal hormone product cyproterone acetate is safe and does not cause a higher incidence of liver cancer in patients taking the drug. The statement was issued in response to the BAM's statement that there is sufficient concern over the safety of Diane-35 and Androcur (both based on cyproterone acetate) to consider using alternative products (Marketletter September 15).

In a submission to the BAM, the company says that it has re-evaluated the drug and has consulted a range of specialists. The conclusion is that there appears to be no indication of a heightened risk of liver-cell cancer through the use of CPA. In addition, notes the firm, it is supported by the German medical organizations representing gynecologists, urologists and endocrinologists.

The head of the Italian research team in Genoa which carried out the studies identifying a possible link between CPA and cancer in rat liver-cell cultures said that the results do not constitute an argument that CPA is carcinogenic and notes that the results are inadequate to support such a claim.