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Articles for Makena, search results for fda

FDA pulls only drug for preterm births, saying it has no benefit
1 year, 8 months ago

FDA pulls only drug for preterm births, saying it has no benefit

LA Times  

The FDA ordered Makena be pulled from pharmacies on Thursday, saying the drug had no benefit for pregnant women. The Food and Drug Administration on Thursday ordered the immediate withdrawal of the only drug meant to prevent preterm birth, saying it’s ineffective and risky for pregnant women. The FDA’s order comes more than two years after the agency first asked …

Women Drug Fda Preterm Birth Makena Covis
FDA panel backs removal of unproven pregnancy drug
2 years, 2 months ago

FDA panel backs removal of unproven pregnancy drug

Associated Press  

WASHINGTON — Federal health advisers have concluded that a drug intended to prevent premature births hasn’t been shown to work, clearing the way for U.S. regulators to follow through on a long-delayed effort to get it off the market. The Food and Drug Administration’s advisory panel voted 14-1 Wednesday that the injectable drug Makena should be withdrawn, despite appeals from …

Market Drug Study Fda Panel Makena Covis
Drug meant to prevent premature births should be removed from market, FDA panel says
2 years, 2 months ago

Drug meant to prevent premature births should be removed from market, FDA panel says

LA Times  

A federal advisory panel voted Wednesday to recommend that the only approved drug to prevent premature birth be removed from pharmacy shelves because studies have shown it does not work. The Times detailed in a February 2022 investigation how the drug’s maker — private equity-owned Covis Pharma of Luxembourg — and the companies that previously owned the rights to Makena …

Women Birth Black Women Drug Study Panel Preterm Birth
FDA pushes to remove pregnancy drug, company pushes back
2 years, 2 months ago

FDA pushes to remove pregnancy drug, company pushes back

Associated Press  

WASHINGTON — The maker of the only U.S. drug intended to prevent premature births is making a last-ditch effort this week to keep its medication on the market, even as health regulators insist that it doesn’t work. “Makena and its associated generics represent the only treatment currently available to obstetrician-gynecologists to help prevent this condition.” But the FDA says existing …

Risk Drug Study Fda Preterm Birth Makena
Science hasn’t shown these medications work. They’re being sold anyway
2 years, 9 months ago

Science hasn’t shown these medications work. They’re being sold anyway

LA Times  

During her pregnancies, doctors encouraged Brittany Horsey to take a preterm birth drug called Makena. “In the vast majority of accelerated approvals,” it said, the drug’s clinical benefits were later verified through the confirmatory studies it required. Exondys 51 Duchenne muscular dystrophy $300,000 per year Aduhelm Alzheimer’s disease $28,200 per year Makena Preterm birth $13,000 per pregnancy For decades, the …

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Editorial: FDA should pull ineffective pregnancy drug Makena until we know it works
2 years, 10 months ago

Editorial: FDA should pull ineffective pregnancy drug Makena until we know it works

LA Times  

Brittany Horsey of Baltimore says she was prescribed Makena during two pregnancies, yet both times the drug failed to work and the babies were born prematurely. The drug’s approval was based on a flawed government- Despite this questionable data and repeated concerns raised by one of its statisticians, the FDA approved the drug in 2011. The FDA says that it …

Women Market Work Fda Medication Makena Pregnancy Drug
A drug for pregnant women doesn’t work, according to the FDA. A company is selling it anyway
2 years, 10 months ago

A drug for pregnant women doesn’t work, according to the FDA. A company is selling it anyway

LA Times  

Brittany Horsey of Baltimore was prescribed the drug Makena during two of her pregnancies because doctors believed she was at risk of giving birth too soon. “We keep injecting pregnant women with a synthetic hormone that hasn’t been shown to work,” said Adam Urato, chief of maternal and fetal medicine at MetroWest Medical Center in Framingham, Mass. The company said …

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