France bans “Diane 35” birth control pill from the pharmaceutical manufacturer Bayer
The “Diane 35” birth control pill is suspected of causing dangerous blood clots. In France, four deaths have been linked to the preparation of the German pharmaceutical company Bayer. As the French drug regulator announced on Wednesday, the market approval of the drug is to be suspended with a transition period of three months.
Doctors should stop prescribing Diane 35 as contraceptive pill Since Monday, doctors in France have been asked to stop prescribing Diane 35 as a contraceptive after four women have been linked to the drug after the death of four women. The preparation has been approved in France as an acne medication since 1987. However, due to its contraceptive effects, it is also prescribed as an birth control pill. According to the French Medicines Agency (ANSM), the drug is to be banned for the time being with a transition period of three months. Within this period, all packs of "Diane 35" would be withdrawn from circulation, the head of ANSM, Dominique Maraninchi, reported on Monday. This decision also affects so-called generics, cheaper imitations. However, women taking "Diane 35" should not stop taking the medication immediately, but should first consult their doctor, advised Maraninchi.
Four blood clot deaths related to Diane 35 birth control pill Since 1987, at least four deaths are believed to have resulted from taking Diane 35. According to the ANSM boss, the women died of venous thrombosis. In 125 other cases there is also a connection with the preparation. Non-fatal blood clots in the veins or arteries were found in these women. The ban on “Diane 35” serves to protect patients. "There are numerous other therapy options," emphasized Maraninchi. Around 315,000 women took the birth control pill or a generic in France last year.
“Diane 35” is approved in 135 countries worldwide, including Germany. As the manufacturer Bayer announced, the drug should only be prescribed for the treatment of acne. There is no recommendation as a contraceptive. In addition, the package insert of "Diane 35" expressly refers to the risk of thrombosis. According to the group spokeswoman Astrid Kranz, the pharmaceutical company was surprised by the ban on the French drug agency. According to Bayer, there were no new scientific findings “that question the positive risk-benefit profile,” Kanz told the news agency “dpa.” The ANSM had neither submitted a report to Bayer nor provided any other information received a press release from the ban on "Diane 35".
The Federal Institute for Drugs and Medical Devices (BfArM) in Bonn had stressed on Monday that the prescription of "Diane 35" in Germany was "no longer possible" for contraception only and was handled "very restrictively".
Taking the birth control pill increases the risk of thrombosis 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 USA. Thrombosis is a blood clot that can lead to pulmonary embolism and stroke and is caused by the estrogens contained in contraceptive pills, such as ethinyl estradiol and progestogens. While birth control pills still contained a lot of ethinyl estradiol, the pills are now in much lower doses. Many contain progestogens because they act against skin diseases such as acne.
At the request of the ANSM, the European drug agency Ema is now also examining these low-dose birth control pills that contain combinations of active ingredients similar to "Diane 35". According to the agency, between 20 and 40 out of 100,000 women develop a blood clot who take an birth control pill within a year. Especially women who use one of the new drugs are at risk. The EMA is currently reviewing whether contraceptive pills can still be prescribed with few concerns and to what extent the side effects and risks are included in the package inserts. However, women should not feel compelled to stop taking the contraceptive pill. If there are concerns, those affected should contact their doctor, the supervisory authority said. (sb)
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