Levonorgestrel and ulipristal remain suitable emergency contraceptives, says EMA

24 July 2014

The European Medicines Agency has concluded its review of emergency contraceptives containing levonorgestrel or ulipristal acetate to assess whether increased bodyweight affects the effectiveness of these medicines in preventing unintended pregnancy following unprotected sexual intercourse or contraceptive failure.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) recommends that these emergency contraceptives can continue to be used in women of all weights as the benefits are considered to outweigh the risks.

In November 2013, following a national procedure, the product information of one emergency contraceptive containing levonorgestrel, Norlevo, was updated on the basis of results from two clinical studies to state that Norlevo is less effective in women weighing 75kg or more and not effective in women weighing more than 80kg. An EU-wide review was then started to assess whether similar information should be included in the product information for other emergency contraceptives that contain levonorgestrel, and for ellaOne, an emergency contraceptive that contains ulipristal acetate.

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