FDA okays drug to cut preterm birth rate

The U.S. Food and Drug Administration this week approved the first drug aimed at reducing the rate of pre-term birth.

Makena, hydroxyprogesterone caproate, is an injection approved to stop preterm delivery before 37 weeks of gestation. It is intended for pregnant women who have had at least one spontaneous preterm birth, and is not advised for use with multiple fetuses, or other risk factors for pre-term birth.

Pregnant Graffiti

One in every eight babies in the United States is born before 37 weeks — 1,500 every day, 13 of whom die from complications.

“Preterm birth is a significant public health issue in the United States,” said Sandra Kweder, M.D., deputy director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. “This is the first drug approved by the FDA that is indicated to specifically reduce this risk.”

A health care provider injects Makena into a woman's hip weekly, beginning at 16 weeks, or no later than 21 weeks gestation.

The FDA approved Makena under its accelerated approval protocol, which requires a drug's manufacturer to continue to research the drug's efficacy and side effects. An international trial is now under way.

Hologic, a Bedford, Mass.-based manufacturing firm that concentrates on women's health, developed Makena, previously known as Gestiva. Hologic recently finalized the sale of the drug to KV Pharmaceuticals of St. Louis, Missouri.

The FDA okayed Makena's use based on a multicenter randomized double-blind trial that looked at 463 women ages 16 to 43 who had a history of preterm birth. Of the subjects treated with Makena, 37 percent delivered their babies before 37 weeks, compared with 55 percent of women in the control group.

The FDA previously approved hydroxyprogesterone caproate in 1956 under the name Delalutin. The drug was withdrawn from the market in 2001 "for reasons unrelated to safety concerns," according to the FDA.

Pregnant Graffiti by Petteri Sulonen

National Birth Defects Prevention Month

The focus this year during January, National Birth Defects Prevention Month, is on the judicious use of medicines before, during and after pregnancy.

That goes for prescription and over-the counter drugs, as well as herbal remedies and dietary supplements.

Perhaps two-thirds of women use some kind of medication during pregnancy, according to the Centers of Disease Control and Prevention in Atlanta, Ga. Yet many of the effects of these drugs are poorly understood.

Pregnant women are often excluded from drug trials because of concerns for their unborn babies. As a result, we often know little about how drugs will affect fetuses.

Birth defects affect about 3 percent of babies born in the United States and cause more than 20 percent of infant deaths, according to the CDC.