The European Medicines Agency is taking aim at preterm birth drugs, with the agency’s safety committee recommending that medicines containing 17-hydroxyprogesterone caproate, also known as 17-OHPC, be suspended.
A review by the safety committee “concluded that there is a possible but unconfirmed risk of cancer in people exposed to 17-OHPC in the womb,” as well as questions around its efficacy.
In its safety announcement, the committee said it analyzed a large study that looked at the risk of cancer in people who had been exposed to the drug in the womb and found that there might be an increased risk of cancer.
“The Committee therefore concluded that the risk of cancer in people exposed to 17-OHPC in the womb is possible, but cannot be confirmed due to uncertainties,” the EMA wrote.
According to the European regulators, 17-OHPC is a synthetic form of hydroxyprogesterone, which naturally occurs in the body and is formed from the hormone progesterone.
The committee cited new studies in its Friday statement that showed how 17-OHPC is not effective in preventing premature birth and there are “limited” data available for its effectiveness in other indications, including fertility disorders and those caused by a lack of progesterone.
This recommendation impacts Austria, France and Italy, where the medicines containing 17-OHPC are authorized and marketed under the names Proluton Depot, Progesterone Retard Pharlon and Lentogest.
The US FDA also cracked down on a preterm birth drug last year, ordering Covis Pharma to pull its drug Makena off the market. Makena won accelerated approval in 2011 but then failed its confirmatory trial after the data showed the drug did not benefit mothers or babies. It also had two FDA adcomms vote to pull the drug.