PRAC’s evaluation of Bayer’s Diane-35 and its generics says that the benefits outweigh the risks.


May 17, 2013 | By Márcio Barra

The Diane – 35 debate seems to have reached its conclusion. Back in January, EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) started an evaluation on third and fourth generation combined oral contraceptives, requested by the French National Competent Authority.

Bayer’s Diane – 35

The French Agence Nationale de Securite du Medicament et des Produits de Sante (ANSM) launched an investigation of its own back then  into the acne drug Diane-35 (cyproterone and ethinylestradiol), from Bayer. The investigation was triggered after four deaths in France were linked to the use of Diane-35, and reports from 125 women who suffered adverse reactions. It was supposedly also used as an off-label contraceptive. This investigation came three weeks after it started a review into Méliane, another Bayer contraceptive, and other third- and fourth-generation birth-contraceptive pills.

Now, after roughly 4 months, the PRAC issued its final evaluation on Diane – 35, and it has come down in support of the drug, even for the reported off-label use. PRAC’s report reads that the ” (PRAC) concluded that the benefits of Diane 35 and other medicines containing cyproterone acetate 2 mg and ethinylestradiol 35 micrograms continue to outweigh their risks for the treatment of moderate to severe acne,” and that “The risk of venous thromboembolism (VTE) occurring with these medicines is low and well known”.

The report came, however, with a suggestion that Diane should only be used when other acne treatments have failed, and proper labeling changes should be done regarding the blood clotting risks. The label should state that Diane can also be used as a hormonal contraceptive and therefore should not be used in combination with other hormonal contraceptives.
The PRAC recommendations will be now evaluated by the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which will then take a final position.

If you want to read more on how this debate started, please go here, here, and here.



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