Information on the combined hormonal contraceptives (CHC) containing the dienogest + ethinyl estradiol combination (Jeanine®)
https://doi.org/10.17749/2313-7347.2019.13.1.007-012
Abstract
In this short communication, the editorial board publishes the information on safety of the combined hormonal contraceptive (CHC) Jeanine®, containing the fixed dose combination of dienogest and ethinyl estradiol. This information has been received from the Russian regulatory authority (Roszdravnadzor) and the manufacturer. According to a metaanalysis of four observational studies, women using the dienogest/ethinyl estradiol fixed dose combination had a higher risk of developing venous thromboembolism (VTE) as compared with women taking the CHCs containing the levonorgestrel/ ethinyl estradiol combination. The estimated risk of developing VTE in women taking the dienogest/ethinyl estradiol combination is 8-11 cases of VTE per 10,000 women per year, while in women taking the CHCs containing levonorgestrel, norethisterone or norgestimate the risk is 5-7 cases of VTE per 10,000 women per year. A patient information leaflet amendment is under consideration by the regulatory authorities. For now, however, hormonal contraceptives containing the dienogest/ethinyl estradiol combination accompanied with the previous version of the instruction are still available in pharmacies. Therefore, when prescribing the combined hormonal contraceptives with dienogest and ethinyl estradiol, the obstetrician-gynecologist should discuss these risks with the woman.
About the Authors
A. D. Makatsariya
I.M. Sechenov First Moscow State Medical University, Health Ministry of Russian Federation
Russian Federation
Russian Federation
Alexander D. MakatsariYa - MD, PhD, Corresponding Member of RAS, Professor, Head of the Department of Obstetrics and Gynecology, Faculty of Clinical and Preventive Medicine, I.M. Sechenov First MSMU HM of RF.
62 St. Zemlyanoi Val, Moscow 109004.
Researcher ID: M-5660-2016
Scopus Author ID: 6602363216
V. O. Bitsadze
I.M. Sechenov First Moscow State Medical University, Health Ministry of Russian Federation
Russian Federation
Russian Federation
Viktoriya O. Bitsadze - MD, PhD, Professor, Department of 0bstetrics and Gynecology, Faculty of Clinical and Preventive Medicine, I.M. Sechenov First MSMU.
62 St. Zemlyanoi Val, Moscow 109004.
Scopus Author ID: 6506003478
D. V. Blinov
Institute of Preventive and Social Medicine; Lapino Clinical Hospital, GC «Mother and Child»; Moscow Medico-Social Institute named after F.P. Gaaz
Russian Federation
Russian Federation
Dmitry V. Blinov - Head of Scientific and Medical Affairs, Institute of Preventive and Social Medicine; Neurologist, Lapino Clinical Hospital, GC «Mother and Child»; PhD, MBA, Lecturer, Department of Neurology, Psychiatry and Narcology, MMSI n.a. F.P. Gaaz.
4-10 Sadovaya-Triumfalnaya St., Moscow 127006; 111,1-e Uspenskoe shosse, Lapino, Moscow region, 143081; 5, s. 1-1a, 2-ya Brestskaya St., Moscow 123056.
Researcher ID: E-8906-2017
RSCI: 9779-8290
D. I. Korabelnikov
Moscow Medico-Social Institute named after F.P. Gaaz
Russian Federation
Russian Federation
Daniil I. Korabelnikov - Rector MMSI n.a. F.P. Gaaz.
5, s. 1-1a, 2-ya Brestskaya St., Moscow 123056.
Теl.: +7(495)1503956.
References
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Review
For citations:
Makatsariya A.D., Bitsadze V.O., Blinov D.V., Korabelnikov D.I. Information on the combined hormonal contraceptives (CHC) containing the dienogest + ethinyl estradiol combination (Jeanine®). Obstetrics, Gynecology and Reproduction. 2019;13(1):7-12. (In Russ.) https://doi.org/10.17749/2313-7347.2019.13.1.007-012
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