Is an EMA review on hormonal contraception and thrombosis needed?

BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f1464 (Published 7 March 2013)
Cite this as: BMJ 2013;346:f1464

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  1. Frans M Helmerhorst, professor in clinical epidemiology of fertility ,
  2. Frits R Rosendaal, professor in clinical epidemiology
  1. 1Leiden University Medical Center, 2300 RC Leiden, Netherlands
  1. F.M.Helmerhorst{at}LUMC.nl

Sufficient evidence exists to recommend the second generation pill with the lowest tolerable oestrogen dose for all indications

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 …

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