The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has advised the suspension of marketing authorisations for therapeutics containing 17-hydroxyprogesterone caproate (17-OHPC) in the European Union (EU).
The recommendation follows a review that raised concerns about an as-yet unconfirmed risk of cancer in individuals exposed to 17-OHPC in the womb.
The PRAC review included a large population-based study spanning 50 years.
Despite the low number of cancer cases and limitations such as insufficient information on cancer risk factors, the committee concluded that a possible cancer risk could not be ruled out.
In addition to cancer risk concerns, new studies have indicated that 17-OHPC is ineffective in preventing premature birth.
PRAC examined a study involving more than 1,700 pregnant women with a history of preterm delivery which found that 17-OHPC did not outperform a placebo in preventing recurrent preterm births or related medical complications in newborns.
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Your download email will arrive shortly
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalData
Two published meta-analyses further confirmed the lack of efficacy in preventing preterm birth.
For other authorised uses of 17-OHPC, such as the treatment of gynaecological and fertility disorders, PRAC found limited evidence of effectiveness.
The committee’s review process also included consultations with experts in obstetrics, gynaecology, fertility treatment, and patient representatives.
In some EU countries, 17-OHPC medicines have been authorised as injections for preventing pregnancy loss or premature birth in pregnant women. They are also used for treating conditions related to progesterone deficiency.
In a media statement, EMA said: “In view of the concern raised by the possible risk of cancer in people exposed to 17-OHPC in the womb, together with the data on the effectiveness of 17-OHPC in its authorised uses, PRAC considered that the benefits of 17-OHPC do not outweigh its risks in any authorised use.
“The committee is therefore recommending the suspension of the marketing authorisations for these medicines. Alternative treatment options are available.”
