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IN THE LATEST health scare to erupt in France, a drug watchdog today announced it was suspending sales of an acne pill also used as a contraceptive after four women died and more than 100 others fell ill with blood clots.
The National Agency for the Safety of Drugs and Health Products (ANSM) said it was suspending sales of a hormonal treatment called Diane-35, which is prescribed to 315,000 women in France.
The move will be phased in over three months to allow users to find an alternative drug, Dominique Maraninchi, the agency’s director, told a press conference.
The product, made by the German firm Bayer, is authorised for treating acne in young women, but doctors have been prescribing it as a contraceptive because it stops ovulation, he said.
“This drug is not licensed for use as a contraceptive,” Maraninchi said.
“But it is being used as such, in this secondary role… yet there are plenty of other alternative contraceptives that can be used in this country.”
Maraninchi said the agency had also carried out a benefit-versus-risk assessment for Diane-35 on the basis of its use as an acne treatment.
The assessment was negative, which explains why the drug is being suspended from the French market, he said.
Diane-35 is sold in 116 countries around the world, according to the ANSM website.
Over 25 years, four women have died and 125 fallen ill from blood clots attributed to Diane-35 or its generics, the ANSM said on Sunday.
Bayer, in an emailed statement to AFP on Sunday, said the risk of clots “is a known effect, and is clearly marked as such in the package advice for patients.”
It added that Diane-35 should only be prescribed for acne, and “in the context of a medical consultation, with respect for appropriate use, side effects and precaution.”
France has been shaken by a series of health scares in recent years.
It has asked the European Medicines Agency (EMA) to change prescription guidelines for so-called third- and fourth-generation oral contraceptives after these drugs were found to carry a higher risk of blood clots compared to earlier versions.
In 2010, the French authorities censured breast implant manufacturer Poly Implant Prothese (PIP) after it was found to be using non-authorised silicone gel that caused a high rate of implant ruptures. Health experts disagree on the risks, though.
Another scandal concerns an anti-diabetes drug called Mediator, manufactured by the French pharmaceutical company Servier, which started being used as a slimming aid because it reduces hunger pangs.
The drug was pulled off the market in 2009 after evidence emerged of hundreds of deaths caused by damage to heart valves.
Are they sold in Ireland anyone know?
Ya they are sold here in Eire and fook all about it well done the journal for pointing that out
Yes Eddie but it’s under a different name.
Acne drugs like Diane 35 or Roaccutane can be very dangerous and are administered as part of a programme of monthly check ups and blood tests. The issue is that it was administered as a contraceptive which it is not something that drug is designed for. This is the doctor’s fault.
Sold here as Dianette.
Off label prescribing is a symptom of off label marketing, a practice that many pharmaceutical companies have faced large fines for in recent years..
Women on contraceptive pills need to be closely monitored, apart from dangers such as clots, they don’t suit everyone and I know of several women who became severely depressed while on the pill. Even now doctors try to bully me to take it and I refuse. Too many bad experiences. There are alternatives. I know the article is about an acne medication being used as a contraceptive, but my point is that doctors don’t always know best.
The pill contains a very high dose of synthetic hormones. Hormones are pretty finicky, they have to be in balance or weird things start happening.
The longer term contraceptives, like the implant / IUD have a far lower dosage and don’t cause quite as many problems as the pill – but they’re not perfect..
There’s a male 10 year contraceptive that’s being tested, it involves injecting a sort of resin into the vas deferens under local anaesthetic, which coats the walls, any sperm passing through are ripped apart by some sort of ionic charge. It’s fully reversible with water and baking soda. Would be great if it caught on – no hormones, no side effects, fully reversible.. Would just have to get guys over the idea of someone fiddling in their sacs for two tiny tubes!
Known as dianette here in Ireland. http://www.medicines.ie/medicine/1951/SPC/Dianette/#INDICATIONS
Still licensed here for use as contraception when present with acne.
The side effects are well documented and the warnings are here. http://www.medicines.ie/medicine/1951/SPC/Dianette/#CLINICAL_PRECAUTIONS
Ha! Literally just came off it after being on it for 6 years! Crazy.
One mans poison is another mans medicine…or in this case a womans…
Yeah! But I tell ye. It sorted my skin out! It was a blessing for me.
Which is……????
Dianette, I think. I was on it for 5 years…
How’s the acne?
I was on Dianette also for years. I was advised that it was a low risk pill unless you were very overweight or a smoker and my doc used to have them in this surgery directly – so you didn’t even have to go to the chemist. Worked well and skin improved greatly – Off them now. Wonder what the doc would say if I told him I wanted to go back on same brand again ……
Dianette is also used for women with endometriosis.
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