21 May 2024

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2024

Hydroxyprogesterone Caproate Medicines to be Suspended from the EU Market


EMA’s safety committee (PRAC) recommended suspending marketing authorisations for medicines containing 17-hydroxyprogesterone caproate (17-OHPC) in the EU. The PRAC review found a possible but unconfirmed risk of cancer in those exposed to 17-OHPC in the womb. The review also considered new studies, which showed that 17-OHPC is not effective in preventing premature birth. Limited data on its effectiveness for other authorised uses also contributed to this decision.


17-OHPC medicines, authorised in some EU countries as injections for preventing pregnancy loss or premature birth and treating various gynaecological and fertility disorders, have been found to have risks outweighing their benefits. The PRAC recommends suspension, noting alternative treatments are available. More information on the PRAC’s review
is available in < -suspended-eu-market> EMA’s public health communication.


New safety information for healthcare professionals: Hydroxyprogesterone caproate Medicines


The PRAC discussed a direct healthcare professional communication (DHPC) for 17-hydroxyprogesterone caproate medicines. The DHPC will inform healthcare professionals about the suspension recommendations and advise considering alternative treatments.

The DHPC will sent to the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) and, once adopted, will be disseminated according to an agreed communication plan and published on the <> Direct healthcare professional communications page and in <> national registers in EU Member States