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

fore 37 weeks, compared with 55 percent of women who did not get the drug, the agency said.

Another study evaluated the development of children born to mothers enrolled in the first trial. Here, children ages 2.5 years to 5 years reached the same developmental targets, whether the mother was given the drug or not.

"The confirmatory study that is ongoing will be followed by a similar infant follow-up study, to be completed about 2018. That study is expected to include 580 to 750 infants, depending on the number of study sites and mothers willing to participate," the FDA says.

Makena is given by injection once a week from the 16th to the 37th week of pregnancy. Known by doctors as 17P, it is a synthetic form of a hormone produced during pregnancy.

Common side effects included pain, swelling or itching at the injection site; hives, nausea and diarrhea, according to the FDA. Serious adverse reactions are rare, although there was a report of a blood clot in the lungs and another of infection at the injection site, the agency noted.

The drug is being marketed by St. Louis-based KV Pharmaceutical.

More information

For more information on premature birth, visit the U.S. National Library of Medicine.

SOURCES: Shelly Burgess, spokeswomen, U.S. Food and Drug Administration; Alan Fleischman, M.D., senior vice president and medical director, March of Dimes; Gene Burkett, M.D., professor of obstetrics and gynecology, University of Miami Miller School of Medicine


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