Drug Approved to Help Prevent Preterm Birth
FRIDAY Feb. 4, 2011 -- Makena (hydroxyprogesterone caproate) has been approved by the U.S. Food and Drug Administration to help prevent birth before 37 weeks of pregnancy in women who have had at least one prior early delivery.
Makena, however, is not intended for women who are at greater-than-average risk for preterm birth because they are pregnant with multiple fetuses, the agency said Friday in a news release.
The drug was sanctioned under an accelerated-approval program that requires post-marketing studies that provide additional proof of the medication's benefit, the FDA said.
Makena is designed to be injected into the hip once weekly by a health-care provider, beginning at 16 weeks and no later than 21 weeks of pregnancy.
In clinical testing involving 463 women aged 16 to 43, 37 percent of those who took Makena delivered early, compared with 55 percent among those who didn't take the drug, the FDA said.
The most common side effects were injection site reactions, hives, nausea and diarrhea, the FDA said.
Makena is manufactured by Hologic Inc., of Bedford, Mass.
The U.S. Centers for Disease Control and Prevention has more about preterm birth.
Posted: February 2011