Drug to forestall preterm birth gains FDA approval

February 10, 2011

The United States Food and Drug Administration (FDA) has approved a drug to decrease the risk of delivery before 37 weeks of pregnancy in women with a history of at least 1 spontaneous preterm birth.

The United States Food and Drug Administration (FDA) has approved a drug to decrease the risk of delivery before 37 weeks of pregnancy in women with a history of at least 1 spontaneous preterm birth.

Hydroxyprogesterone caproate (Makena) is injected into the hip once weekly beginning at 16 weeks, and no later than 21 weeks, of pregnancy. It’s not indicated for women with a multiple pregnancy or other risk factors for preterm birth. The most common reported side effects included pain, swelling, or itching at the injection site, hives, nausea, and diarrhea. Serious adverse effects were rare-a single report each of pulmonary embolism and infection at the injection site.

“Preterm birth is a significant public health issue in the United States,” says Sandra Kweder, MD, 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.”

FDA reviewed data on the safety and effectiveness of the drug in a multicenter, randomized, double-blind clinical trial of 463 women 16 to 43 years of age with a singleton pregnancy and a history of spontaneous preterm birth. Thirty-seven percent of women treated with the drug gave birth earlier than 37 weeks, compared with 55% of controls. A separate study of children born to mothers enrolled in the clinical trial found that children between 2.5 and 5 years of age achieved similar developmental milestones regardless of the mother’s treatment.

Approval was granted under FDA’s accelerated approval regulations. Originally approved in 1956 under the brand name Delalutin, hydroxyprogesterone caproate was withdrawn from the market in 2000 for reasons unrelated to safety.