TGA warns on Diane-35 safety

A European review has concluded the benefits of the drug 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 in Australia for the treatment of androgenisation in women, including severe acne and hirsutism.

The European Medicines Agency (EMA) acted after

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