22.05.2024 - PRAC recommendation

Hydroxyprogesterone caproate medicines to be suspended from the EU market

Review of studies raises possible safety concern and finds no effect in preventing premature birth

EMA’s safety committee, PRAC, has recommended the suspension of the marketing authorisations for medicines containing 17-hydroxyprogesterone caproate (17-OHPC) in the European Union (EU). A review by the PRAC concluded that there is a possible but unconfirmed risk of cancer in people exposed to 17-OHPC in the womb. In addition, the review considered new studies which showed that 17-OHPC is not effective in preventing premature birth; there are also limited data on its effectiveness in other authorised uses.  

12.05.2023 - Procedure started

Note: As of 10.12.2005, no hydroxyprogesterone-containing drugs are authorized in Germany.

EMA has started a review of medicines containing hydroxyprogesterone following concerns about the safety and effectiveness of these medicines. In the EU, these medicines are available as hydroxyprogesterone caproate and are given as injections to prevent pregnancy loss or premature birth in pregnant women. In some countries they are also authorised for the treatment of various gynaecological disorders, including disorders caused by a lack of a hormone called progesterone.

Further information

For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):