The safety of the acne drug Diane-35, which has also been used as a contraceptive, has now been confirmed by a EU medicines watchdog, despite oppositions from France, which has suspended its use
France Suspends Acne Drug
The National Agency for the Safety of Drugs and Health Products (ANSM) said it was suspending sales of a hormonal treatment called Diane-35 made by German firm Bayer.
The National Agency for the Safety of Drugs and Health Products (ANSM) said it was suspending sales of a hormonal treatment called Diane-35 made by German firm Bayer.
It should not be used in combination with hormonal contraceptives, as this would expose the user to double doses of the female hormone oestrogen and a higher risk of potentially deadly blood clots.
The CMDh is tasked with resolving disagreements between EU member states and assuring uniform drug safety measures.
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Diane-35 is authorised in over 100 countries and used by millions of women.
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The leaflet seeks to discourage the drug's use for birth control alone -- although Diane-35's hormone make-up means it acts as a contraceptive by blocking ovulation.
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In January, French health regulator ANSM suspended sales of the hormone tablet, which it linked to four deaths and more than 100 cases of blood clots in the past 25 years.
In France, Diane-35 had been authorised for acne treatment but had also sometimes been prescribed as a contraceptive -- about 315,000 women in the country used it in 2012.
The CMDh's decision will now be sent to the European Commission for a legally binding decision to be applicable throughout the EU -- including France.
Source-AFP
