Health Discoveries in General Health News

FDA approves drug to reduce pre-term births

February 8, 2011
A drug to reduce pre-term deliveries before 37 weeks of pregnancy in women who have a history of such births has been approved by the U.S. Food and Drug Administration (FDA).

The drug, Makena (hydroxyprogesterone caproate), is not for use by women with a multiple pregancy or who may have other risk factors for pre-term births.

The FDA is requiring additional clinical study to learn whether the drug, sponsored by California-based Hologic, will reduce the number of babies who don't survive a pre-term birth and any health problems that occur as a result of such births. The confirmatory study is expected to be completed about 2018.

"Preterm birth is a significant public health issue in the United States," said Dr. Sandra Kweder, deputy director of the FDA's Office of New Drugs. "This is the first drug approved by the FDA that is indicated to specifically reduce this risk."

The drug regimen calls for a pregnant women to be given an injection of Makena into the hip starting at 16 weeks into the pregnancy and no later than 21 weeks.

Within the North Shore-LIJ Health System, both North Shore University Hospital and Long Island Jewish Medical Center are Regional Perinatal Centers (RPCs) for high-risk obstetrical and neonatal management.
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