FDA approves drug to reduce mothers' risk of preterm birth

March 1, 2011

FDA has approved the first drug to help prevent premature birth before 37 weeks of pregnancy in women who have had at least one previous preterm delivery.

NATIONAL REPORTS-FDA has approved Makena, a drug commonly referred to as "17P," the first drug to help prevent premature birth before 37 weeks of pregnancy in women who have had at least one previous preterm delivery.

FDA originally approved hydroxyprogesterone caproate injection under the trade name Delalutin in 1956 for use in pregnant women, but the original manufacturer requested the withdrawal of Delalutin from the market in 2000 for reasons unrelated to safety.

Prior to FDA's recent approval of Makena, healthcare providers ordered prescriptions of 17P from compounding pharmacies, however, eligible patients faced access barriers.

Mitzi Wasik, regional director, clinical pharmacy, Coventry Healthcare, shares a similar viewpoint.

"The American College of Obstetrics and Gynecology has recommended weekly 17P injections for high-risk pregnancies since 2003," Wasik says. "The introduction of this new product will allow more women who meet criteria as high risk for preterm delivery to receive preventive treatment."

A national study estimates that if all women eligible for the progesterone injections received them, nearly 10,000 spontaneous premature births might be prevented each year.