EMA recommends suspending approval for 17-OHPC medicines due to unconfirmed cancer risk and ineffectiveness in preventing premature birth.
The European Medicines Agency (EMA) has recommended suspending approval for 17-hydroxyprogesterone caproate (17-OHPC) medicines, used to prolong gestation, citing a "possible but unconfirmed" risk of cancer. The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) reviewed new studies showing the treatment is not effective in preventing premature birth and has also assessed the risk of cancer in people exposed to 17-OHPC in the womb. In some EU countries, 17-OHPC medicines are authorised as injections to prevent pregnancy loss or premature birth in pregnant women.
May 17, 2024
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