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EMA reviews effectiveness of morning-after pill for overweight women

Clinical The European Medicines Agency is reviewing whether any changes should be made to the product information for emergency contraceptives, following a request from the Swedish medicines regulatory agency

The European Medicines Agency (EMA) is reviewing emergency contraceptives to examine whether they are less effective in overweight women. 


The EMA is assessing whether increased body weight and body mass index reduce the effectiveness of levonorgestrel (Levonelle) and ulipristal (ellaOne), following a request from the Swedish medicines regulatory agency, it announced on Friday (January 24).


Contraceptives containing levonorgestrel are less effective for women weighing 75kg or more and ineffective for women weighing more than 80kg, according to manufacturer HRA Pharma

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The review comes after the French manufacturer HRA Pharma changed the product information for its morning-after-pill Norlevo, which contains the hormone levonorgestrel, in November last year.


The new information states that clinical trials had found the efficacy of the contraceptive was reduced in women weighing 75kg or more and did not prevent unwanted pregnancies in women weighing more than 80kg.


The EMA said last week that it would assess whether any changes should be made to the product information for all other emergency contraceptives.


The review is being carried out by the Committee for Medicinal Product for Human Use (CHMP). It will forward its views to the European Commission, which will make the final decision.



What do you make of the EMA's review?

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2 Comments

cathryn brown, Community pharmacist

So not happy about the headline, and the photo used for this article. As always, a "big" lady with no head...
For taller women, a weight of 75kg would be well within the healthy range so classing it as an issue for overweight women is not appropriate.

John Randell, Non Pharmacist Branch Manager

volume of distribution and all that jazz from 1st and 2nd year pharmacy school....i could have told you that...

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