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.
In some EU countries, 17-OHPC medicines are authorised 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…
