SIDE EFFECTS AND SPECIAL PRECAUTIONS
Administration of cyproterone acetate
during the hormone-sensitive
differentiation phase of the genital
organs (after approximately day 45 of
gravidity) could lead to signs of
feminisation in male foetuses following
higher doses. Observation of male newborn
children who had been exposed in utero to
cyproterone acetate did not show any signs
of feminisation. However, pregnancy is a
contra-indication for the use of
Diane-35.
Recognised first-line tests of
genotoxicity gave negative results when
conducted with cyproterone acetate.
However, there is some evidence of
genotoxicity as further tests showed that
cyproterone acetate was capable of
producing adducts with DNA (and an
increase in DNA repair activity) in liver
cells from rats and monkeys and also in
freshly isolated human hepatocytes. This
DNA adduct formation occurred at exposures
that might be expected to occur in the
recommended dose regimens for cyproterone
acetate. One in vivo consequence of
cyproterone acetate treatment was the
increased incidence of focal, possibly
pre-neoplastic, liver lesions in which
cellular enzymes were altered in female
rats.
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