The FDA pulled the only approved drug for premature birth
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The FDA’s Obstetric, Reproductive and Urologic Drugs Advisory Committee voted against Makena after a large study of the effects on preterm birth
In October, the FDA’s Obstetrics, Reproductive and Urologic Drugs Advisory Committee voted that Makena should not remain on the market after a large study failed to show that it was effective. The evidence didn’t show that Makena reduced the risk of stillbirths in women who had had one before and it also didn’t show any benefit to babies from a postmarket trial.
Covis said that soon after the committee hearing, it outlined a plan for withdrawal that included a wind-down period allowing patients to finish the 21-week course of treatment. The plan was rejected by the FDA’s Center for Drug Evaluation and Research.
“It is tragic that the scientific research and medical communities have not yet found a treatment shown to be effective in preventing preterm birth and improving neonatal outcomes,” FDA Commissioner Robert M. Califf said in a statement on Thursday.
Hundreds of thousands of babies are born preterm every year in the U.S. It’s one of the top causes of infant deaths according to a March of Dimes report last year. And preterm birth rates are highest for Black infants compared to other racial and ethnic groups. There is only one approved treatment to prevent preterm birth.
Why is it logical to put a stop to medicine that doesn’t work? A comment by J. N. Kaimal, MD, M. C. Iwasawa, J. A. Yamabe, Ph. D.
The decision to pull the drug immediately was taken by Califf and chief scientist, who quoted a University of South Florida professor.
It would not make sense to give patients a medicine that doesn’t seem to work, when there is another trial to be had, said Kaimal.
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