EMA safety committee suspends medication for premature births

The European Medicines Agency (EMA) has suspended the use of hydroxyprogesterone caproate medicines, which mimic the hormone progestin, amid doubts about their medical benefits and concerns that they may be linked to an increased risk of cancer.

Medicines from this group of medicines are sometimes given to reduce the risk of premature birth, especially if an expectant mother has given birth to a premature baby in the past.

The decision was prepared by the EMA safety committee, PRAC (Pharmacovigilance Risk Assessment Committee). The PRAC concluded that there is a possible but unconfirmed risk of cancer in people exposed to hydroxyprogesterone caproate (17-OHPC) in utero.

In addition, recent studies showed that 17-OHPC is not effective in preventing preterm birth, and there were also limited data on its effectiveness in other approved uses, such as various gynecological and fertility disorders, particularly those associated with a deficiency naturally produced progesterone.

The study that led to this decision involved a large cohort and examined the cancer risk of people exposed to 17-OHPC in utero over a period of approximately 50 years from birth. The data suggests that these people may have an increased risk of cancer compared to people who were not exposed to the drugs.

However, it should be noted that there were only a very small number of cancer cases and the committee concluded that the risk of cancer in people exposed to 17-OHPC in utero is possible but not confirmable. Given its questionable benefits in preventing premature births, it was considered better to suspend the measure.

In addition to scientific studies, PRAC sought the opinions of experts in obstetrics, gynecology and fertility treatment as well as patient advocates.

For those concerned about premature birth, alternative treatment options are available.

(Edited by Zoran Radosavljevic)