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Emergency Contraception – New information on levonorgestrel (Levonelle, Norlevo, Tyedra, Levonorgestrel Teva) and ulipristal (ellaOne)

Notice type: Advisory

Date: 24/07/2014
 

Product name or type:
Levonelle, Norlevo, Tyedra, Levonorgestrel Teva and ellaOne

Active Substance:
levonorgestrel, ulipristal

Updated Information for Healthcare Professionals:
The European Medicines Agency today concluded that levonorgestrel and ulipristal are suitable emergency contraceptives for all women, irrespective of body weight. This follows a review of emergency contraceptives 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, 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 75 kg or more and not effective in women weighing more than 80 kg. Subject to approval of the CHMP recommendation, by the European Commission, this statement will be deleted from the Norlevo product information.

Actions To Be Taken:

The HPRA will continue to work with the Marketing Authorisation Holders for the above mentioned medicines and will ensure that revised educational material is provided to healthcare professionals as soon as possible. In the meantime, the HPRA recommends that:

  • Emergency contraceptives can continue to be used to prevent unintended pregnancy in women of any weight or body mass index (BMI). The available data are limited and not robust enough to support with certainty the conclusion of decreased contraceptive effect with increased bodyweight/BMI.

Further Information:
EMA Press Release

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