The European Medicine Agency’s safety committee has recommended the suspension of the marketing authorisations for medicines containing 17-hydroxyprogesterone caproate (17-OHPC) in the European Union, after reviews suggested a possible but unconfirmed cancer risk in people exposed to the drug in the womb.
Last year, MedicalBrief reported that the US Food & Drug Administration (FDA) had withdrawn the drug (Makena) from the market – the only medication ever approved (in 2011) to prevent preterm births – after a 2019 study found no evidence that it works.
Thousands of women were prescribed the medication after it launched, amid mixed opinions on its efficacy.
In some countries, the medicines were authorised as injections not only to prevent pregnancy loss or premature birth in pregnancy but also to treat certain gynaecological and fertility disorders caused by a lack of progesterone.
The recent review by the safety committee, PRAC, concluded there was a possible but unconfirmed risk of cancer in people exposed to 17-OHPC in the womb, and additionally, considered new studies showing that 17-OHPC is not effective in preventing premature birth; there are also limited data on its effectiveness in other authorised uses.
The PRAC reviewed the results from a large population-based study looking at cancer risks in people who had been exposed to 17-OHPC in the womb – over a period of about 50 years from the time they were born.
Data from this study suggest these people might have an increased risk of cancer compared with those who were not exposed to the medicines.
The PRAC noted, though, that there was a low number of cancer cases in the study, and some limitations, like limited information on risk factors for cancer.
The committee concluded that the risk of cancer in people exposed to 17-OHPC in the womb was possible, but could not be confirmed due to uncertainties.
The PRAC also considered data on the effectiveness of 17-OHPC medicines in their authorised uses, including the results from a study looking at how well they prevented premature birth.
The study, which involved more than 1 700 pregnant women with a history of preterm delivery, found that 17-OHPC is no more effective than placebo in preventing recurrent premature birth or medical complications due to prematurity in newborns.
Two published meta-analyses were also reviewed, confirming that 17-OHPC is not effective at preventing preterm birth.
During the review, input was also sought from experts in obstetrics, gynaecology and fertility treatment, and from patient representatives.
In view of the concern raised by the possible risk of cancer in people exposed to 17-OHPC in the womb, and the data on the effectiveness of 17-OHPC in its authorised uses, the PRAC considered that the benefits of 17-OHPC do not outweigh its risks in any authorised use.
See more from MedicalBrief archives:
FDA pulls controversial pre-term birth drug
Complications in first pregnancy linked with increased risk of subsequent preterm birth
Blood test successfully predicts premature birth