French health regulator launches investigation into contraceptive Dianette after deaths

Drug is used as a contraceptive and to treat teenage acne

France’s health regulator has launched an investigation into the contraceptive drug Dianette after four people died from thrombosis linked to its use.

62,000 women in the UK are prescribed the drug each year, which is also used to treat acne and polycistic ovaries.

Concerns about the drug have been raised in France following four recent deaths, while in Canada 11 deaths have been linked to the pills.

In 2011 a 16-year-old from Yorkshire, Shannon Deakin, died after taking Dianette for four weeks before dying from deep vein thrombosis.

Dianette, known as Diane-35 in France, is a combination of cyproterone, a form of the female hormone progesterone and ethinylestradiol, an oestrogen.

Although other oral contraceptives also carry an increased risk of DVT, the use of cyproterone in the drug means it has one of the highest blood clot risks of all oral contraceptives.

Cyproterone is 65 per cent more likely to cause a blood clot than levonorgestrel, which is a type of progesterone found in older oral contraceptive pills, according to a review published in 2012 in the European Journal of Contraception And Reproductive Health Care.

According to the Medicines and Healthcare Products Regulatory Agency (MHRA), the risk is small, with 40 of every 100,000 women on it developing a blood clot in one year, compared with between five and ten women in 100,000 who don’t take the drug.

The MHRA still maintain the drug is safe, saying: ‘Despite recent developments in France, we have no new concerns and there is no need for a woman who is feeling well to stop taking her medicine.

‘If women have any concerns about their treatment, they should contact their doctor.’

Dianette is made by German pharmaceutical company Bayer. A spokesperson for the company said: ‘Although Dianette also acts as an oral contraceptive, it should not be used solely for contraception, but reserved for those women requiring treatment for the androgen-dependent conditions (acne)’ and added that the blood clot risk was ‘known and clearly indicated in the patient information leaflet’.

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