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3rd and 4th generation pill: lessons from the scandal
December 2012, Marion Larat’s complaint has the effect of a bomb. The 32-year-old young woman, severely disabled following a stroke, blames her condition on her contraceptive, a 3rd generation pill named Méliane. She attacks the Bayer laboratory which produces this pill. 14 other complaints will follow, also targeting other laboratories. Two years after the Mediator affair, the preferred contraceptive of French women finds itself at the heart of a health scandal. Hitherto unknown, the dangers of pills, in particular those of the 3rd and 4th generation, are emerging in broad daylight. We discover that these contraceptives run a risk of thromboembolic accident (phlebitis, pulmonary embolism) twice as high as the 2nd generation pills.
Restriction of the prescription of 3rd and 4th generation pills
Faced with the pressure, the Minister of Health, Marisol Touraine, decides to reimburse these contraceptives which present health risks. She is also setting up a toll-free number to answer questions from women. In early January 2013, doctors received an instruction from the National Medicines Safety Agency (ANSM) to only prescribe 1st and 2nd generation pills as a first-line treatment. The College of French Gynecologists (CNGOF) agrees. “Following the still recent studies, showing an increased risk of venous thrombosis with 3rd generation pills, the recommendation to prescribe a 2G pill in first intention is justified”, insists Bernard Hédon, President of the CNGOF. However, women who have been using a 3rd or 4th generation pill for several months should not stop it without medical advice. The risk of revelation of a venous thrombosis appearing mainly during the first weeks of the prescription. In March 2013, an ANSM report concluded that all generations combined, the pills cause an average of “2 venous thromboembolic accidents” and “ 20 premature deaths of women including 14 attributable to 3rd and 4th generation pills. “
The controversy does not end. In mid-February 2013, around sixty new complaints were lodged with the Paris tribunal de grande instance. Among them, victims of the 3rd and 4th generation pills, but also of the anti-acne treatment Diane 35. This dermatological drug is the subject of misuse as a contraceptive because it does not have a marketing authorization. the French market (AMM) only for the treatment of acne. Dominique Maraninchi, director of the ANSM then announces that it is necessary to stop using Diane 35 as a contraceptive. “Diane 35 multiplies by 6,68 the risk of venous thrombosis compared to women not taking oral contraception,” he explains. The drug agency confirms four deaths “attributable to venous thrombosis linked to Diane 35”, over the past 25 years. This drug will no longer be sold as of May 21, 2013. But this decision raises reservations among professionals, in particular among gynecologists. The Syndicate of Gynecologists (SYNGOF) asks in particular that “the balance between risks and advantages is correctly ensured, sheltered from the media emotions and the interests which any could draw to the detriment of certain women bruised by acne”.
3rd generation pill, Diane 35: France’s position contested at European level
May 2013, The European Medicines Agency (EMA) disapproves of France’s decision to ban Diane 35, considering that Diane 35’s benefits outweigh its risks, but criticizes its excessive use as a contraceptive method. Two months later, the European Commission requires France to put this anti-acne treatment back on the market. Same observation as the EMA, the benefit / risk ratio remains positive. Nevertheless, she decides to restrict the prescriptions of this acne medication. The suspension of the sale of Diane 35 is lifted on July 31, 2013. Final rebound in the fall, the European Medicines Agency declares itself in favor of 3rd and 4th generation pills, the benefits of which remain greater than the risks, according to it, despite a higher rate of accidents due to venous thrombosis. A turnaround that does not surprise Dr. Marie-Claude Benattar, gynecologist: “In this case, everything has been exaggerated”, she regrets. “We the specialists who are in the field, we know that these pills have qualities and that if we do the right investigations with the patients, then there are no more risks. ” Diane 35 and its generics will be back on the market in January 2014, but with restriction of the indication, modification of the contraindications and reinforcement of the warnings against the risks of blood clots, according to the Medicines Agency (ANSM).
Women have changed contraception
Undoubtedly, the controversy around 3rd and 4th generation pills has shaken women’s confidence in their method of contraception. The media boom that followed caused confusion and concern among many French women. Nevertheless, positive point, women have become aware of the risks of the contraceptive pill. “We feel that they are more vigilant, they ask questions, whereas previously we had entered into a certain trivialization of the act of prescribing contraception, especially among very young women,” notes Dr. Benattar. Proof of the evolution of mentalities, almost one in 5 women has changed contraceptives since January 2013. This figure was revealed by the Ministry of Health on the occasion of World Contraception Day, September 26, 2013. French women are now turning to 1st and 2nd generation pills and intrauterine devices such as the IUD (+ 26% in 1 year). Contrary to what one might have imagined, the various scandals have not pushed women to give up taking a method of contraception and the number of abortions has remained stable.
Dr Marie-Claude Benattar has published “Scandals, women’s health in danger”, published by J.Lyon.