Medicines based on 17-hydroxyprogesterone caproate will be suspended from the EU market due to oncological risks in unborn children. This was announced by the European Medicines Agency, EMA, following the recommendation of the Pharmacovigilance and Safety Committee Prac which met from 13 to 16 May. The review of these products by the PRAC, announced a year ago by the EMA, concluded that “there is a possible, but not confirmed, risk of cancer in people exposed to 17-hydroxyprogesterone caproate in the uterus“. The review also evaluated new studies demonstrating that “17-hydroxyprogesterone caproate is not effective in preventing premature births. There is also limited data on its effectiveness in other authorized uses”, the EMA further specifies.
In some European Union countries, the regulatory body recalls, 17-Ohpc-based drugs are approved as injections to prevent miscarriage or premature birth in pregnant women. They are also licensed for the treatment of various gynecological and fertility disorders, including problems caused by deficiency of the hormone progesterone.
“In view of the concern raised by the possible risk of cancer in people exposed to 17-Ohpc “during life” in utero, together with the data on the effectiveness of 17-Ohpc in its authorized uses – continues the EMA – the PRAC considered that the benefits of 17-Ohpc do not outweigh the risks of any approved use the suspension of marketing authorizations for these medicines. Alternative treatment options are available, the agency points out.
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