FDA Should Ban Makena

Meena Aladdin, Health Researcher at Public Citizen’s Health Research Group, Testifies on Hydroxyprogesterone Caproate

The U.S. Food and Drug Administration (FDA) must remove from the market Makena (generic name hydroxyprogesterone caproate) and prohibit pharmacy compounding of the medication because it is not effective for preventing preterm birth or related complications, Meena Aladdin, health researcher at Public Citizen’s Health Research Group, said in testimony today before the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee.

The FDA approved hydroxyprogesterone in 2011 as the brand-name product Makena solely to reduce the risk of preterm birth in certain high-risk women. However, Makena’s approval was based largely on evidence from a single clinical trial that was seriously flawed and did not provide any evidence that the medication reduced the rate of fetal and neonatal health problems and death.

A recent clinical trial that was required by the FDA as a condition of Makena’s approval found that the drug is not effective for preventing preterm birth or major complications related to preterm birth.

Aladdin testified that maintaining approval of Makena in the absence of any clinical benefits being demonstrated by the two clinical trials would make a mockery of the more than 50-year FDA legal standard requiring substantial evidence of a drug’s effectiveness.

Read Aladdin’s testimony here.

Read Public Citizen’s petition to the FDA to ban Makena here.