Is an EMA review on hormonal contraception and thrombosis needed?BMJ 2013; 346 doi: https://doi.org/10.1136/bmj.f1464 (Published 07 March 2013) Cite this as: BMJ 2013;346:f1464
- Frans M Helmerhorst, professor in clinical epidemiology of fertility ,
- Frits R Rosendaal, professor in clinical epidemiology
- 1Leiden University Medical Center, 2300 RC Leiden, Netherlands
Four recently reported deaths in women using the Diane-35 contraceptive and a lawsuit against the French drug authority (L’Agence Nationale de Sécurité du Médicament) after it banned Diane-35 led the authority to request that the European Medicines Agency (EMA) review the safety of combined oral contraceptives.1 2 Of particular concern were third and fourth generation drugs, including Diane-35 and its generics. This review was granted on 7 February 2013.3 4 The Dutch College for the Evaluation of Medicines (Dutch “EMA”) decided that a new study on Diane-35 was in order.
Most oral contraceptives are combination preparations, containing a progestogen, to prevent ovulation, and an oestrogen to prevent breakthrough bleeding. Since the introduction of the pill, the oestrogen dose, in the …