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FDA Approves First Drug to Prevent Premature Births
Date:2/7/2011

By Steven Reinberg
HealthDay Reporter

FRIDAY, Feb. 4 (HealthDay News) -- The U.S. Food and Drug Administration has approved the first drug to help prevent premature birth in women who have had at least one previous preterm delivery.

The drug -- called Makena (hydroxyprogesterone caproate) -- is expected to reduce the risk of premature delivery, which experts say raises the risk of infant complications at birth, lifelong disabilities such as cerebral palsy, and even death.

Preterm delivery is a serious problem in the United States, FDA spokeswoman Shelly Burgess said.

According to the March of Dimes, preterm birth -- or the birth of a baby at less than 37 completed weeks of pregnancy -- affects one in eight babies born in the United States, she noted.

What's more, the rate of preterm birth has increased more than 35 percent in the last 25 years in the United States, and late preterm births -- babies born at 34 to 36 weeks of pregnancy -- account for nearly three-quarters of such births, Burgess said.

Makena will reduce the risk of preterm delivery before 37 weeks of gestation in pregnant women with a history of at least one spontaneous preterm birth, Burgess noted.

She added that Makena is approved for a certain subset of all U.S. women at risk for preterm birth: those carrying one baby (known as a "singleton pregnancy") who previously gave birth prematurely to one baby.

According to the agency, the drug is not intended to be used by women having twins or other risk factors for preterm birth.

The March of Dimes applauded the FDA's decision.

"The most common risk factor for preterm birth is recurrence," said Dr. Alan Fleischman, March of Dimes senior vice president and medical director. "This is the first approved drug to prevent recurrence for women who have had a singleton preterm baby and now have a singleton baby," he added. "That will dramatically [lower the] rate for
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