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European Medicines Agency started a review of emergency contraceptives

24.01.2014

The European Medicines Agency (EMA) has started a review of emergency contraceptives to assess whether increased body weight and body mass index reduce the efficacy of these medicines in preventing an unintended pregnancy following unprotected sexual intercourse or conceptive failure.

Emergency contraceptives act by blocking and/or delaying ovulation. Available emergency contraceptive medicines in the European Union contain levonorgestrel or ulipristal acetate.

The EMA will evaluate the impact of new data suggesting that a high bodyweight could impair the effectiveness of emergency contraceptives. It will assess whether any changes should be made to the product information for all emergency contraceptive medicines containing levonorgestrel or ulipristal acetate.

More about the medicines

The emergency contraceptives being reviewed include a number of medicines authorised at the national level that contain the progestogen levonorgestrel, such as Escapelle and Vikela. It also includes a centrally-authorised medicine, ellaOne, which contains ulipristal acetate and was granted a marketing authorisation in the European Union in 2009.

Emergency contraceptives containing levonorgestrel can be used up to 72 hours after unprotected sexual intercourse or contraceptive failure while ulpristal acetate can be used up to 120 hours.

The review is being conducted by the Committee for Medicinal Products for Human Use (CHMP), responsible for all questions concerning medicines for human use. The CHMP opinion will then be forwarded to the European Commission for a legally-binding decision.

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