24 May 2024
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2024
The EMA’s safety committee (PRAC) recommended suspending the marketing authorisations for 17-hydroxyprogesterone caproate (17-OHPC) medicines in the EU due to a possible cancer in people exposed to 17-OHPC in the womb and a lack of effectiveness in preventing premature birth. Limited data on other uses also contributed to the decision. These medicines, which are used in some EU countries to prevent pregnancy loss and treat gynaecological disorders, have been found to have risks that outweigh their benefits. Healthcare professionals will be advised to consider alternative treatments through a direct healthcare professional communication (DHPC).
For more information, see here.
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