January 28, 1:43 pm
(ANSA) - PARIS, JAN 28 - It's not just the 3rd and 4th generation pills that are being accused in France: Diane 35, an anti-acne treatment often used as a contraceptive and produced by the pharmaceutical giant Bayer, is also now being singled out for its secondary effects which can be devastating. In France, four fatal cases of venous thrombosis in the last 25 years are "clearly" linked to the use of this drug, according to data provided by the National Medicines Safety Agency (ANSM). The newspaper Le Figaro, which has had access to medical documents, speaks of seven cases. In France, 315,000 women take Diane 35 (data from 2012), a drug authorized in 1987 as a treatment to combat acne. The presence of synthetic hormones, such as estrogen and a progesterone derivative, have extended its use to contraceptive pills. "We must stop using Diane 35 as a contraceptive," underlined today the director of the ANSM, Dominique Maraninchi, speaking on RTL radio. A report on the drug is expected this week. The debate on the use of Diane 35 reaches the one that is spreading in France on the use of so-called 3rd and 4th generation pills, which multiply the risks of vascular accidents. About thirty complaints have been made in France in recent weeks. Meanwhile, a study by the university hospital of Brest (west), disclosed today by Le Figaro, found that the 80% of women who have had an accident related to the use of the pill had at least one risk factor: smoking (in half of the cases), high blood pressure, being overweight or long plane journeys. According to the document that the newspaper was able to obtain, the Brest laboratory analyzed 550 cases of hospitalization of women aged between 15 and 45 who suffered thrombosis, pulmonary embolisms or cerebral vascular accidents between 1998 and 2012: 155 of them took the pill, and three of these died. The German pharmaceutical group Bayer reacted yesterday by emphasizing that the risk of thrombus formation, i.e. clots of blood in the veins, is "known and clearly indicated in the leaflet" present in the Diane 35 package and that this treatment had to be prescribed "only against acne in compliance with the contraindications". (HANDLE)
Contraceptive pills, the EMA will review the safety of 3rd-4th generation pills
The European Medicines Agency so far describes the pills as having a "very rare risk" of thrombosis, but a new special panel will review the risks associated with the use of these contraceptives and therefore the possible need to change the guidelines for their use.