Review of emergency contraceptives started
24 January 2014
EMA/36862/2014
Press Office
Press Release
Review of emergency contraceptives started
The European Medicines Agency has started a review of emergency contraceptives to assess whether increased bodyweight and body mass index (BMI) reduce the efficacy of these medicines in preventing an unintended pregnancy following unprotected sexual intercourse or contraceptive failure.
Emergency contraceptives act by blocking and/or delaying ovulation. Available emergency contraceptive medicines in the European Union contain levonorgestrel or ulipristal acetate.
The European Medicines Agency 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 (hormone) levonorgestrel, such as Norlevo, Levonelle/Postinor and Levodonna. It also includes a centrally-authorised medicine, ellaOne, which contains ulipristal acetate and was granted a marketing authorisation in Europe in 2009.
Emergency contraceptives containing levonorgestrel can be used up to 72 hours after unprotected sexual intercourse or contraceptive failure while ulipristal acetate can be used up to 120 hours. Levonorgestrel-containing emergency contraceptives are available 'over the counter' in certain European countries. EllaOne can only be obtained with a prescription.
More about the procedure
The review of emergency contraceptives started at the request of the Swedish medicines regulatory agency, under Article 31 of Directive 2001/83/EC.
It follows a procedure finalised in November 2013 for Norlevo, an emergency contraceptive medicine containing levonorgestrel, to add the following information to the summary of product characteristics: 'In clinical trials, contraceptive efficacy was reduced in women weighing 75 kg or more, and levonorgestrel was not effective in women who weighed more than 80 kg'. This information is currently not reflected in the product information for other emergency contraceptives containing levonorgestrel.
For ulipristal acetate, no information regarding the woman's weight or BMI is currently included in the product information.
The review is being conducted by the Committee for Medicinal Products for Human Use (CHMP), the Committee 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.
Notes
This press release, together with all relevant documents is available on the Agency's website.
More information on the work of the European Medicines Agency can be found on its website: www.ema.europa.eu
Contact our press officer
Monika Benstetter
Tel. +44 (0)20 7418 8427
E-mail: [email protected]