The European Medicines Agency's (EMA) safety committee, PRAC, has recommended the suspension of marketing authorisations for medicines containing 17-hydroxyprogesterone caproate (17-OHPC) in the European Union (EU). This decision follows a review which indicated a possible but unconfirmed risk of cancer in individuals exposed to 17-OHPC in the womb. Additionally, new studies have shown that 17-OHPC is ineffective in preventing premature birth, and there is limited data on its effectiveness in other authorised uses.

Authorised Uses and Concerns

In some EU countries, 17-OHPC medicines are authorised as injections to prevent pregnancy loss or premature birth in pregnant women, and for treating various gynaecological and fertility disorders related to a lack of progesterone. The PRAC reviewed a large population-based study which suggested a potential increased risk of cancer in people exposed to 17-OHPC in the womb. However, due to the low number of cancer cases and study limitations, the risk remains unconfirmed.

Effectiveness Studies

The PRAC also evaluated the effectiveness of 17-OHPC in its authorised uses. A significant study involving over 1,700 pregnant women with a history of preterm delivery found that 17-OHPC was no more effective than a placebo in preventing recurrent premature birth or associated complications in newborns. Two meta-analyses further confirmed the ineffectiveness of 17-OHPC in preventing preterm birth. Limited evidence was found supporting its effectiveness in other authorised uses.

Expert Opinions and Recommendations

During the review, input was sought from experts in obstetrics, gynaecology, and fertility treatment, as well as patient representatives. Based on the potential cancer risk and lack of effectiveness, the PRAC concluded that the benefits of 17-OHPC do not outweigh its risks in any authorised use, recommending the suspension of its marketing authorisations. Alternative treatments are available.

About 17-OHPC

17-hydroxyprogesterone caproate (17-OHPC) is a synthetic form of hydroxyprogesterone, a hormone involved in preparing and maintaining the womb lining during pregnancy. It was expected to reduce pregnancy loss and premature labour and to treat infertility and gynaecological disorders caused by progesterone deficiency. 17-OHPC is available as an injectable solution and is authorised in Austria, France, and Italy under the trade names Proluton Depot, Progesterone Retard Pharlon, and Lentogest.

Highlights

• Recommendation: PRAC recommends suspension of 17-OHPC medicines in the EU due to potential cancer risk and ineffectiveness.
• Uses: Previously used to prevent pregnancy loss, premature birth, and treat gynaecological and fertility disorders.
• Study Findings: Large study and meta-analyses confirm ineffectiveness in preventing preterm birth; potential cancer risk remains unconfirmed.
• Expert Input: Recommendations based on input from experts and patient representatives.
• Alternative Treatments: Available for the conditions previously treated with 17-OHPC.