Other safety alerts
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| European Union: Review of hydroxyprogesterone started |
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European Medicines Agency (EMA) announces that it has started a review of medicines containing hydroxyprogesterone following concerns about the safety and effectiveness of these medicines. In the European Union (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 the lack of a hormone called progesterone.
EMA’s safety committee, Pharmacovigilance Risk Assessment Committee (PRAC), started this review due to concerns about results from a study 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 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 study 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uses and to issue a recommendation on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the EU.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-10-12-may-2023
In Hong Kong, there is no registered pharmaceutical product containing hydroxyprogesterone.
Ends/Saturday, May 13, 2023
Issued at HKT 13:00
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