EMA has started a review of emergency contraceptives

This new review started at the request of the Swedish medicines regulatory agency and concerns emergency contraceptives containing levonorgestrel or ulipristal acetate.

The objective is to evaluate the influence of increased bodyweight and BMI on efficacy of these emergency contraceptives. There has already been carried out a procedure with the emergency contraceptive Norlevo (levonorgestrel). The clinical trials prooved that contraceptive efficacy was decreased in women weighing 75 kg or more, and in women weighing more than 80 kg levonorgestrel was not effective.. This information is currently not reflected in the product information for other emergency contraceptives containing levonorgestrel, therefore it has to be assessed further and the possible change in product information will be discussed. 

Original source


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