Hydroxyprogesterone caproate has not been without some controversy. In 2006, an FDA advisory committee considering hydroxyprogesterone caproate to treat preterm birth brought up safety concerns, including a possible association with second trimester miscarriages.
Hydroxyprogesterone caproate is also the same drug as a much older one called Delalutin, which was approved by the FDA in 1956 and was used to treat female hormone disturbances and cancer, but withdrawn from the market for business reasons in 2008, the agency says.
"Makena is chemically the same as Delalutin," Burgess said.
What is new here is that a drug company will be making the drug; it won't have to be made up in pharmacies, according to Fleischman. "There will be consistency and high quality. This makes it a breakthrough not only that it's FDA approved and doctors will be comfortable in recommending it, but also there will be high quality and consistency for women as they take it," he said.
Dr. Gene Burkett, a professor of obstetrics and gynecology at the University of Miami Miller School of Medicine said that "this is something we have been using with women prone to preterm labor. It has been almost a standard of care for the last five or six years."
"Makena was approved under FDA's accelerated approval regulations, which allow promising drugs to be approved based on showing a benefit on a 'surrogate endpoint' that is likely to predict an actual clinical benefit," Burgess said. In this case, it was reducing the risk of delivery before 37 weeks.
Part of the terms of this approval require the manufacturer to conduct studies that demonstrate that the drug has a clinical benefit, she said.
In making its decision, the FDA reviewed data on the safety and effectiveness of Makena from a clinical trial that included 463 pregnant women who had a history of a spontaneous preterm birth.
Among those receiving Makena, 37 percent delivered be
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