EU regulator scraps approval for pregnancy drug over cancer risk

By Thomson Reuters May 17, 2024 | 6:40 AM

(Reuters) – The European Medicines Agency (EMA) on Friday recommended scrapping approval for a drug used to prolong gestation, citing a “possible but unconfirmed” risk of cancer.

The EU health regulator’s Pharmacovigilance Risk Assessment Committee (PRAC), which monitors drug-related side effects, considered new studies in its review that showed the treatment, 17-hydroxyprogesterone caproate (17-OHPC), was not effective in preventing premature birth.

It also reviewed results from a study which looked at the risk of cancer in people who had been exposed to 17-OHPC in the womb. PRAC considered data on the effectiveness of the medicines in their authorised uses and decided to recommend withdrawing approval for the drug.

In some EU countries, 17-OHPC medicines are authorised as injections to prevent pregnancy loss or premature birth in pregnant women, according to the regulator. They are also authorised for treating various gynaecological and fertility disorders, including those caused by the lack of a hormone called progesterone.

Last year, the U.S. Food and Drug Administration (FDA) withdrew its approval for Covis Pharma’s preterm birth prevention drug, Makena, saying that the drug was not effective in treating the complication.

(Reporting by Eva Mathews in Bengaluru; Editing by Anil D’Silva)