US mothers face uncertainty as lone, unproven drug for preterm birth pulled
Makena is the only drug approved specifically to prevent premature birth, a major health issue facing children and families, in the US. In the 12 years since it was fast-tracked by the US Food and Drug Administration (FDA), hundreds of thousands of patients in America have received injections of Makena, which is about 5,200% more expensive than generic versions of the same medication.
There was just one problem: there’s no evidence Makena actually works.
After years of crossfire with the FDA, the Swiss drugmaker Covis announced earlier this month that Makena would be pulled from the market, since a major study focused on the drug indicated it had no benefit.
One in 10 babies are born early in the United States, and preemies may experience lifelong health and development issues, in addition to the economic and emotional costs of premature birth. There are also dramatic disparities among those born too soon. While 9.2% of white infants are born early, 14.2% of Black infants and 11.6% of American Indian and Alaska Natives infants are born before 37 weeks of gestation in the US, according to 2021 data from the March of Dimes.
To address this pressing issue, the FDA granted accelerated approval for Makena in 2011, allowing patients to access the medication while the injection was studied for effectiveness. An estimated 350,000 people in the US with singleton pregnancies and a history of preterm birth have since received the shots.
https://www.theguardian.com/us-news/2023/mar/23/makena-premature-birth-drug-pulled-us-reaction
Reminding you that the last unproven drug for preterm births (DES) continued in use for years, despite evidence that it didn't work, and not only caused problems for the women it was given to, but abnormalities in their children, especially daughters (ever heard the term "DES daughters"?) but also sons, and now problems are cropping up in the the grandchildren, including boys.