The US Food and Medication Organization declared its ultimate choice to pull out its endorsement of Makena, a medication supported over 10 years prior to lessen the gamble of preterm birth that had been the main drug endorsed for the condition. The FDA says that the medication isn’t successful and that the advantages of taking it don’t offset the dangers.
According to FDA Commissioner Dr. Robert Califf, it is tragic that the medical and scientific communities have not yet discovered a treatment that has been shown to be effective in preventing preterm birth and improving neonatal outcomes. This is especially true in light of the fact that this serious condition has a disparate impact on communities of color, particularly Black women.
However, a favorable benefit-risk analysis is the criterion for FDA drug approval; The drug should not have been granted approval by the FDA unless that favorable evaluation was provided.
In the United States, about one in ten babies are born before 37 weeks of pregnancy, or preterm. Preterm birth increases both the baby’s and the mother’s risk of death and disability because the brain and lungs stop developing in the last few months of pregnancy.
According to the US Centers for Disease Control and Prevention, Black women have a rate that is approximately 50% higher than that of White or Hispanic women. In the United States, preterm birth has also become a growing issue. According to the CDC, the rate increased by 4% from 10.1% in 2020 to 10.5% in 2021. Because these patients lacked dependable medication options prior to Makena, the FDA accelerated its approval process.
When a drug shows promise in clinical trials but there is no reliable treatment for the condition, this procedure is used. It was developed by the FDA during the height of the AIDS pandemic, when a record number of people were dying without any other options. A drug that receives expedited approval does not have to undergo all of the human testing required by the standard approval procedure.
After a clinical trial demonstrated a reduction in the rate of preterm births but no direct clinical benefit, Makena was approved in 2011 for use in women who have a history of spontaneous preterm birth.
