Hydroxyprogesterone-containing medicinal products
- Procedure started
- Under evaluation
- PRAC recommendation
- CMDh position
- European Commission final decision
Table of contents
Overview
Review of hydroxyprogesterone started
EMA has started a review of medicines containing hydroxyprogesterone following concerns about the safety and effectiveness of these medicines. In the EU, these medicines are available as hydroxyprogesterone caproate and are given as injections to prevent pregnancy loss or premature birth in pregnant women. In some countries they are also authorised for the treatment of various gynaecological disorders, including disorders caused by a lack of a hormone called progesterone.
EMA’s safety committee (PRAC) started this review due to concerns about results from a study1 which suggested that people who were exposed to hydroxyprogesterone caproate in the womb may have an increased risk of cancer compared with those who were not. The risk seemed to increase when the medicine was used during the first trimester of pregnancy and with the number of injections given. The use of hydroxyprogesterone caproate during the second or third trimester appeared to further increase the risk of cancer for males but not for females.
In addition, results from a second study2 suggested that hydroxyprogesterone caproate is no more effective than placebo in preventing recurrent premature birth or medical complications due to prematurity in the newborn infant.
As a result of these concerns, the French medicines agency (ANSM) requested the PRAC to review the risks and benefits of these medicines in all their approved uses and to issue a recommendation on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the EU.
EMA will communicate PRAC’s recommendations once the review has concluded.
1 Murphy CC, et al. In utero exposure to 17α-hydroxyprogesterone caproate and risk of cancer in offspring. Am J Obstet Gynecol. 2022 Jan;226(1):132.e1-132.e14. doi:10.1016/j.ajog.2021.10.035
2 Blackwell, S. C. et al. 17-OHPC to prevent recurrent preterm birth in singleton gestations (PROLONG Study): A multicenter, international, randomized double-blind trial. Am J Perinatol. 2020 Jan;37(2):127-136. doi:10.1055/s-0039-3400227.
Key facts
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About this medicine
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|---|---|
| Approved name |
Hydroxyprogesterone-containing medicinal products
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| International non-proprietary name (INN) or common name |
hydroxyprogesterone
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| Associated names |
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| Class |
progestogens
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About this procedure
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|---|---|
| Current status |
Procedure started
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| Reference number |
EMEA-H-A-31-1528
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| Type | |
| Authorisation model |
Nationally authorised product(s)
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| Decision making model |
PRAC-CMDh
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Key dates and outcomes
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|---|---|
| Procedure start date |
12/05/2023
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All documents
Procedure started
Hydroxyprogesterone-containing medicinal products Article 31-referral - Notification (PDF/55.6 KB) (new)
First published: 12/05/2023
Hydroxyprogesterone-containing medicinal products Article 31-referral - Timetable for the procedure (PDF/110.96 KB) (new)
First published: 12/05/2023
EMA/PRAC/194263/2023
Hydroxyprogesterone-containing medicinal products Article 31-referral - PRAC List of questions (PDF/198.2 KB) (new)
First published: 12/05/2023
EMA/PRAC/194264/2023
Hydroxyprogesterone-containing medicinal products Article 31-referral - Annex I (PDF/123.47 KB) (new)
First published: 12/05/2023
EMA/194533/2023
Description of documents published
Please note that some of the listed documents apply only to certain procedures.
- Overview - lay-language summary of the stage of the procedure
- Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
- Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
- List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
- Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
- List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
- List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
- Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
- Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
- Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
- Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
- Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
- Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
- Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
- Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)
Note that older documents may have different titles.