The European Medicines Agency (EMA) has recommended the suspension of marketing authorizations for medicines containing 17-hydroxyprogesterone caproate (17-OHPC) in the European Union (EU), basing this decision on a review carried out by the PRAC – –the Pharmacovigilance Risk Assessment Committee, whose role is to evaluate all aspects of the risk management of medicines for human use– which concluded that there is a possible, but unconfirmed, risk of cancer in people exposed to 17-OHPC in the womb.
Additionally, the review considered new studies that showed that 17-OHPC is not effective in preventing preterm birth; There is also limited data on its effectiveness in other authorized uses. In some countries of the European Union, medicines with 17-OHPC are authorized as injections in pregnant women to prevent pregnancy loss or premature birth. They are also approved for the treatment of various gynecological and fertility disorders, including those caused by a lack of a hormone called progesterone.
The benefits of 17-OHPC do not outweigh its risks in any of its uses.
The PRAC reviewed the results of a large population-based study that examined the risk of cancer in people who had been exposed to 17-OHPC in utero, over a period of approximately 50 years from birth. Data from this study suggest that these people may have a higher risk of cancer compared to those who were not exposed to the drugs.
However, the PRAC noted that there were a low number of cancer cases in the study and that the study had some limitations, such as limited information on risk factors for cancer. Therefore, the Committee concluded that the risk of cancer in people exposed to 17-OHPC in utero is possible, but cannot be confirmed due to uncertainties.
In its review, the PRAC also considered data on the effectiveness of 17-OHPC medicines in their approved uses, including results from a study that evaluated their effectiveness in preventing preterm birth. The study, which included more than 1,700 pregnant women with a history of preterm birth, found that 17-OHPC is no more effective than a placebo (a dummy treatment) in preventing recurrent preterm birth or medical complications due to prematurity. in newborns.
The Committee concluded that the risk of cancer in people exposed to 17-OHPC in utero is possible, but cannot be confirmed due to uncertainties.
The Committee also reviewed two meta-analyses (combined analyzes of multiple studies), one published in The Lancet and the other in The BMJ, which confirmed that 17-OHPC is not effective in preventing preterm birth. For other authorized uses of 17-OHPC, the PRAC concluded that there is limited evidence of its effectiveness. During the review, opinions were also sought from experts in obstetrics, gynecology and fertility treatments, as well as patient representatives.
In view of the concerns raised about the possible risk of cancer in people exposed to 17-OHPC in utero, together with data on the effectiveness of 17-OHPC in its approved uses, the PRAC considered that the benefits of 17-OHPC were not exceed its risks in any of its authorized uses. Therefore, the Committee is recommending the suspension of the marketing authorizations for these medicines. There are alternative treatment options available.
