European Medicines Agency recalls drugs due to cancer risk

European Medicines Agency (EMA, for its abbreviation in English) will suspend marketing authorizations for medicines containing 17-hydroxyprogesterone caproate (17-OHPC) in the European Union, tyou can conclude that There is a possible but unconfirmed risk of cancer in people exposed to 17-OHPC in utero, and it is not effective in preventing preterm birth.

The recommendation comes from the Pharmacovigilance Risk Assessment Committee (PRAC), which conducted a review of available data that also shows doubts, due to limited data, about its effectiveness in other approved uses. Additionally, they note that there are alternative treatment options for current use of hydroxyprogesterone caproate.

17-Hydroxyprogesterone caproate (17-OHPC) is a synthetic form of hydroxyprogesterone that occurs naturally in the body and is formed from progesterone. Progesterone is involved in preparing the endometrium (uterine lining) for pregnancy and maintaining it during pregnancy. 17-OHPC is thought to attach to receptors (targets) on cells that progesterone normally targets. It was expected to reduce the risk of pregnancy loss or premature birth in pregnant women and help treat some types of infertility and gynecological diseases associated with a lack of progesterone.

17-OHPC, which has different pharmacological properties from progesterone, is available as an injection. In the EU, the drug is currently approved in Austria, France and Italy under the trade names Proluton Depot, Progesterone Retard Farlon and Lentogest. And they are approved as injections to prevent pregnancy loss or premature birth in pregnant women. They are also approved for the treatment of various gynecological diseases and fertility disorders, including disorders caused by a lack of the hormone progesterone.

Given concerns about the possible risk of cancer in people exposed to 17-OHPC in utero, and evidence of the effectiveness of 17-OHPC when used in its approved use, PRAC considered that the benefits 17-OHPC does not exceed its risks for any approved use.. Therefore, the Committee recommends that the marketing authorizations for these medicines be suspended.