Makena, a new drug approved by the Food and Drug Administration in the United States, may help reduce the risk of premature birth in women who are at higher risk of entering pre-term labor.

Makena, a new drug approved by the Food and Drug Administration in the United States, may help reduce the risk of premature birth in women who are at higher risk of entering pre-term labor. Pre-term labor is defined as labor starting on or before the 36th week of pregnancy. Doctors note the drug is made for women pregnant with singlets and not twins or more.

Treatments with Makena should begin in the 16th week of pregnancy, but the drug can be started as late as the 21st week. Shots are given in the hip and continue for the duration of the pregnancy, weekly. Women who participated in the study before Makena was approved gave birth early in 37-percent of cases. The placebo group gave birth early 55-percent of the time.

A current study is beginning that will test the learning rates of children born to mothers given Makena. The study currently has more than 500 participants and is expected to be completed no later than 2018. Makena was first approved for use by women who were at higher risk of miscarriage. The original drug name was Delalutin and was approved in 1956. The drug was taken off the market in 2000 by the manufacturer; a re-approval process was required at which time the drug was named Makena.

Source: Release by the U.S. Food and Drug Administration. 6 February, 2011.