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calendary July 30, 2024

Preparations of 17-hydroxyprogesterone caproate may contribute to an increased risk of developing cancer

In mid-May, the recommendations of the European Safety Committee (PRAC) on the suspension of registration certificates for medicines containing 17-hydroxyprogesterone caproate (17-OHPC) as an active ingredient in the EU were published on the EMA website.

Substance 17-OHPC is a part of medicines for the treatment of conditions associated with insufficiency of the corpus luteum, such as, for example, amenorrhea (primary and secondary). In some European countries, a synthetic analogue of progesterone is used for the threat of miscarriages or premature birth in pregnant women. Nevertheless, the latest data from the PRAC show that 17-OHPC is an ineffective means to combat premature birth.

In addition to the lack of effectiveness, the safety committee has data that allow us to suspect a relationship between the use of 17-OHPC drugs and an increased risk of developing cancer in people exposed to this substance in the womb.

The basis for such suspicions were studies conducted over 50 years on people who were exposed to 17-OHPC in the prenatal period of development. The study showed that, perhaps, the risk of developing cancer in the subjects is higher than in people who were not exposed to 17-OHPC, but this cannot be stated with certainty. This is due to limited information about the predisposition to cancer in the subjects and, in general, a small number of cases of cancer.

Due to the availability of alternative treatment options and the fact that the risk from using the drug exceeds its benefit, the European Safety Committee recommends that registration certificates for drugs with the active substance 17-OHPC to be canceled.

Two drugs with 17-OHPC are registered in Russia. Both drugs are manufactured by JSC DALKHIMPHARM.

References:
  1. https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-13-16-may-2024
  2. https://www.ema.europa.eu/en/news/hydroxyprogesterone-caproate-medicines-be-suspended-eu-market

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