The drug is prescribed for the treatment of acne and polycystic ovaries, but it is also used as a contraceptive, a fact that the French agency responsible (ANSM) disputes. After the death of 7 women, 4 of which are directly related to Diane 35, the order of its suspension was given, and has up to 3 months to be fulfilled, when all lots must be out of circulation and no prescription can be prescribed. neither for him nor for his generic version.
Bayer, the company that makes Diane 35, has stated that its sale is approved for different indications in 116 countries, and that in France it was authorized for acne treatment in women. In addition, the manufacturer informs that precautions related to the problems experienced by the patients in question are listed in the package leaflet, and is willing to continue to collaborate with the authorities and share relevant information regarding the use of the product, since the sale of the pills is monitored as it requires prescription.
In Portugal, there was a statement by the Portuguese Society of Obstetrics and Maternal-Fetal Medicine (SPOMMF), the Portuguese Society of Contraception (SPdC) and the Portuguese Society of Gynecology (SPG) that, despite the cases, there is no reason to suspend medicine, as long as they are closely monitored, although they find the news alarming.
Here, Anvisa is following the facts, and although it has not yet suspended the sale, a warning was given to the risk of use in patients with a history of thrombosis or vascular problems, as the other 3 deaths have been proven and are related to the compound. For those who use the drug, it is recommended to seek your specialist and look for a new solution.
- Contraceptive methods
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