Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 – 12 May 2023

Review of hydroxyprogesterone started

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 the lack of a hormone called progesterone.

EMA’s safety committee (PRAC) started this review due to concerns about results from a study1 which suggested that people who were exposed to hydroxyprogesterone caproate in the womb may have an increased risk of cancer compared with those who were not. The risk seemed to increase when the medicine was used during the first trimester of pregnancy and with the number of injections given. The use of hydroxyprogesterone during the second or third trimester appeared to further increase the risk of cancer for males but not for females…