PRAC May 2024 – 17-hydroxyprogesterone caproate medicines to be suspended from the EU market

date: 13/06/2024

During its May 2024 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended the suspension of the marketing authorisations for medicines containing 17-hydroxyprogesterone caproate (17-OHPC) in the European Union (EU). 

Possible risk of cancer and ineffectiveness
The PRAC has concluded that there is a possible but unconfirmed risk of cancer in people exposed to 17-OHPC in the womb. In addition, new studies showed that 17-OHPC is not effective in preventing premature birth. There are also limited data on its effectiveness in other authorised uses.   

17-OHPC medicines
In Belgium, 17-OHPC medicines are not authorised whereas in some EU countries, they are approved as injections to prevent pregnancy loss or premature birth in pregnant women. They are also authorised for the treatment of various gynaecological and fertility disorders, including disorders caused by a lack of a hormone called progesterone. 

Suspension of the marketing authorisations
In view of the concern raised by the possible risk of cancer in people exposed to 17-OPHC in the womb, together with the evidence on the effectiveness of 17-OHPC in its authorised uses, the PRAC considered that the benefits of 17-OHPC do not outweigh its risks in any authorised use. The Committee is therefore recommending the suspension of the marketing authorisations for these medicines. Alternative treatment options are available. 
More information is available on the EMA website.

Last updated on 13/06/2024