A US Food and Drug Administration advisory committee voted Wednesday that a drug approved more than a decade ago to reduce the risk of preterm birth should not be allowed to remain on the market after a larger study failed to show that it was effective. It’s now up to FDA leaders to make a final decision about whether to remove the drug from the market.
It noted that risk of preterm labor is higher for Black and other minority women and argued that withdrawal of accelerated approval “would have significant negative public health consequences for high-risk pregnant women, including Black and minority women and socially disadvantaged populations.” In a statement after Wednesday’s meeting, Raghav Chari, Covis’ chief innovation officer, said the company believes that “Makena is effective in a higher-risk patient population.
Nice. Now do the Covid💉.
Whoever is approving and disapproving anything is really using us humans as lab rats.
So what are the effects of this drug? Amen