Drugs

Ban Pre-Term Birth Drug Makena: Public Citizen

Public Citizen says FDA should remove from the market Amag Pharmaceuticals’ Makena (hydroxyprogesterone caproate) and all of its generic forms, indicated for preventing pre-term birth in certain pregnant women, because it is not effective. The advocacy organization says it and an expert in maternal-fetal medicine filed a petition with the agency seeking the ban.

Hydroxyprogesterone was initially approved by FDA in 1956 as Delautin to treat several gynecological and obstetrical conditions, including habitual and threatened miscarriages, Public Citizen says. It notes that by 1973 the agency had concluded that the drug had not been shown to be effective for the miscarriage use and was unable to treat any pregnancy-related conditions because of evidence linking it to congenital heart defects in infants of mothers given the drug during pregnancy.

At the request of Bristol-Myers Squibb, the manufacturer, FDA withdrew Delautin in 2000 because it had not been marketed for several years.

FDA approved hydroxyprogesterone again in 2011 as Makena, solely to reduce the risk of pre-term birth in certain high-risk women, using the accelerated approval pathway. Public Citizen says the approval was based largely on evidence from a single clinical trial that an advisory committee found did not adequately prove that the medication reduced the rate of fetal and neonatal health problems and death. The petition says an FDA statistical expert also opposed approval because data from the trial failed to provide convincing evidence that Makena was effective.

Under the requirements of the accelerated approval pathway, FDA in 2011 told Makena’s then- manufacturer, Hologic, Inc., to complete a larger trial to determine the medication’s effectiveness. Public Citizen reports that on 3/8, Amag Pharmaceuticals, the current manufacturer, announced that the trial – called the PROLONG trial – showed that hydroxyprogesterone was not effective in reducing the rate of preterm birth prior to 35 weeks of pregnancy or the rate of fetal and neonatal health problems and death.

“It is inconceivable that FDA would have approved Makena if the results of the PROLONG trial had been available prior to approval,” says Public Citizen health researcher Meena Aladdin

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