EMA’s PRAC recommends 17-OHPC med suspension
At its meeting this week the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) reviewed medicines regarding their safety.
The PRAC has recommended the suspension of the marketing authorizations 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.
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