Diane-35 safety review prompts VTE rethink

The move comes as a European review concluded the benefits of the drug – an anti-androgenic progestogen-oestrogen combination – outweigh the risks, provided several measures are taken to minimise VTE risk.

“TGA has recently completed its review of Diane-35 and has contacted the sponsor in regard to updating the Product Information with further information on the risk of VTE,” a spokeswoman said.

Bayer’s Diane-35 (cyproterone/ethinyloestradiol), is approved for treating androgenisation in women, including severe acne

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