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Marie Lanen
Head of parenting sections (baby, pregnancy, family), psychology and beauty
Since August 21, the marketing authorization (AMM) for the specialty Progesterone Retard Pharlon 500 mg/2 ml, IM injection solution in ampoule (Bayer laboratory) has been suspended by the ANSM. Doctissimo tells you more.
“The marketing authorization for the medicinal product Progesterone Retard Pharlon (hydroxyprogesterone caproate) is suspended“, here is what we can read in the latest press release from the National Agency for the Safety of Medicines and Health Products (ANSM). This medication is indicated to prevent miscarriages or premature birth, and in the treatment certain gynecological and fertility disorders, including those linked to a lack of progesterone. What to do as a patient?
A decision following a recommendation from the pharmacovigilance committee of the European Medicines Agency (Prac)
In May 2023, the pharmacovigilance committee of the European Medicines Agency (Prac) initiated, at the request of the ANSM, the reassessment of the benefit/risk balance of medicines containing hydroxyprogesterone. This re-evaluation followed the results of a pharmacoepidemiological study suggesting that hydroxyprogesterone caproate could be associated with a higher risk of cancers (of all types) in the offspring of women treated during pregnancy. On the other hand, efficacy data from a recent clinical trial did not show any benefit in using hydroxyprogesterone caproate in the prevention of preterm birth in women with a history of spontaneous preterm birth, or in the reduction of serious events associated with prematurity in newborns. This lack of effectiveness in this type of indication is also confirmed by other recent meta-analyses.
Why is this drug withdrawn from the market?
The European Medicines Agency (EMA) has estimated that:
- The benefit of this medication has not been demonstrated in the prevention of premature births;
- There is a potential risk of cancer in people exposed in utero (in the womb) when their mother was treated with hydroxyprogesterone caproate during pregnancy.
As a reminder, Progesterone Retard Pharlon is indicated to prevent miscarriages or premature birth, and in the treatment of certain gynecological and fertility disorders, including those linked to a lack of progesterone. In France, this medicine has no longer been marketed since April 2023. All boxes still present in the distribution circuit or pharmacies are recalled as of August 21, 2024.
I was treated with Progesterone Retard Pharlon during my pregnancy, what should I do?
The drug Progesterone Retard Pharlon, containing hydroxyprogesterone caproate, has no longer been distributed in pharmacies in France since April 2023. As of August 21, 2024, pharmacies which still had certain stocks will no longer be able to market it because its AMM has been suspended. It was prescribed in the treatment of gynecological disorders such as cycle irregularities, management of infertility, prevention of miscarriages or premature birth.
The ANSM information note specifies that if you have questions about your past treatment, you are strongly advised to contact your doctor for further information on the procedure to follow.