France banned birth control pill Diane 35

France bans contraceptive pill „Diane 35“ of the pharmaceutical manufacturer Bayer

31.01.2013

The birth control pill „Diane 35“ is suspected of causing dangerous blood clots. In France, four deaths have been linked to the product of the German pharmaceutical company Bayer. The French medicines regulator announced on Wednesday that marketing approval of the drug will be suspended for a transitional period of three months.

Doctors should „Diane 35“ Do not prescribe more as an anti-birth control pill
Since Monday doctors are called in France, „Diane 35“ no longer to be prescribed as a contraceptive after the death of four women has been linked to the use of the drug. The product has been approved in France since 1987 as an acne medication. However, it is also prescribed as an anti-contraceptive pill due to its preventive effect. According to the French Medicines Agency (ANSM), the funds will be banned for the time being with a transitional period of three months. Within this period, all packs of „Diane 35“ withdrawn from the market, the head of ANSM, Dominique Maraninchi, reported on Monday. This decision also concerns so-called generic drugs, cheaper counterfeiting. Women who „Diane 35“ However, should not stop the drug immediately, but first see their doctor, advised Maraninchi.

Four deaths due to blood clots related to birth control pill „Diane 35“
Since 1987, at least four deaths on the intake of „Diane 35“ be due. According to the ANSM chief, the women had died as a result of venous thrombosis. In 125 other cases there is also a connection with the preparation. In these women, non-fatal blood clots were found in the veins or arteries. The ban of „Diane 35“ serve the protection of the patients. „There are many other therapy options“, stressed Maraninchi. Around 315,000 women took the contraceptive pill or a generic medicine in France last year.

„Diane 35“ is authorized worldwide in 135 countries, including Germany. As the manufacturing company Bayer informed, the drug may only be prescribed for the treatment of acne. A recommendation as a contraceptive would not exist. In addition, in the leaflet of „Diane 35“ expressly referred to the risk of thrombosis. According to company spokeswoman Astrid Kranz, the pharmaceutical company is surprised by the ban on the French medicines agency. Bayer therefore had no new scientific knowledge, „question the positive benefit-risk profile, "Kanz told the news agency „dpa“. The ANSM had neither submitted a report to Bayer nor provided any other information. The group had only by a press release from the ban for „Diane 35“ experience.

The Federal Institute for Drugs and Medical Devices (BfArM) in Bonn had stressed on Monday that the prescription of „Diane 35“ in Germany exclusively for contraception „not possible anymore“ be and very „very restrictive“ handled.

Taking the contraceptive pill increases thrombosis risk
The fact that taking birth control pills increases the risk of thrombosis has been known since 1960, when the first pill was approved in the US. Thromboses are blood clots that can lead to pulmonary embolism and strokes and are caused by estrogens such as ethinyl estradiol and progestins in contraceptive pills. While contraceptive pills initially contained a lot of ethinylestradiol, the pills today are much smaller doses. Many contain progestins, as they work against skin diseases such as acne.

At the request of ANSM, the European Medicines Agency Ema is now also investigating these lower-dose birth control pills, which have similar combinations of active ingredients „Diane 35“ contain. The agency said that between 20 and 40 out of every 100,000 women contract a blood clot that takes an antidandruff pill within a year. Especially women who use one of the new drugs are at risk. Whether contraceptive pills can still be prescribed with a small number of concerns and to what extent the side effects and risks in the leaflets are sufficiently indicated, the EMA is currently examining. However, women should not feel compelled to stop taking the birth control pill. In case of concerns, those affected should contact their doctor, according to the regulator. (Sb)

Also read:
Antibaby syringe stopped for the man
Despite protest: the birth control pill will be 50 years old
Endometriosis unbearable menstrual pain
Pepper for menstrual disorders