If the FDA won’t protect pregnant women & babies, who will it protect? (25 August 2022)

Summary

In this article, Maryanne Demasi looks at the continued prescription of Makena, an injectable synthetic hormone approved by the US Food and Drug Administration (FDA) to women who are at high-risk of premature delivery. Makena claims to reduce the risk of pre-term birth and was approved in 2011 on an accelerated pathway by the FDA following an initial trial that showed positive outcomes. However, Demasi explains, the study has been discredited as flawed in its methods and findings, and a confirmatory trial conducted by the manufacturer showed that Makena does not actually prevent preterm birth. In spite of this, and in the face of known risks, Makena is still being prescribed to pregnant women as the manufacturer has refused to withdraw it from the market.

She highlights the dangers of the FDA not taking stronger action against the manufacturer of Makena, by looking at the example of Diethylstilbestrol (DES), a synthetic hormone use by women from the 1930's to the 1970s to prevent miscarriages and premature births. DES was later found to cause cancers, immune and cardiovascular disorders and other abnormalities in pregnant women, their children and their grandchildren.