FDA approves first drug to halt premature labor - Daily Dose - Boston.com

FDA approves first drug to halt premature labor - Daily Dose - Boston.com

Pregnant women at risk of going into premature labor now finally have a drug option that can help them reach full term. The US Food and Drug Administration on Friday approved Makena, a progesterone injection to reduce the risk of preterm delivery in women who have already had a preterm birth -- defined as before 37 weeks of pregnancy.

That's big news considering that some 12 percent of women give birth prematurely and that preterm babies are at greater risk of having lung problems, learning disabilities, and of dying during infancy and even later in childhood, according to a 2008 study published in the Journal of the American Medical Association.

Unfortunately, though, Makena (hydroxyprogesterone caproate) isn't a cure-all for preterm birth. In a clinical trial of 463 pregnant women who had previously had preterm delivery, some 37 percent of women who had weekly Makena injections -- starting between 16 and 21 weeks -- delivered prematurely compared with 55 percent of the control group.

"The magnitude of the effect is modest," says Dr. Michael Greene, chief of obstetrics at Massachusetts General Hospital; he wrote an editorial that accompanied the clinical trial study, which was published eight years ago in the New England Journal of Medicine. "But we don't have anything that's better."

Hydroxyprogesterone caproate was actually approved by the FDA, under the name Delalutin, some 55 years ago to halt an impending miscarriage. It was deemed safe but the manufacturer took it off the market in 2000 since it was shown to be worthless at stopping miscarriages.

Since the 2003 study which was funded by the National Institute of Child Health and Human Development, Greene has been ordering the medication from a compounding pharmacy and providing weekly injections to his patients who have had previous preterm births. "They wind up with sore rear ends, but I haven't seen any side effects other than that."

The FDA notes that "the most common side effects reported with Makena included pain, swelling, or itching at the injection site; hives, nausea, and diarrhea. Serious adverse reactions were rare; there was a single report each of blood clot in the lungs (pulmonary embolism) and an infection at the injection site."

The FDA waited eight years after the original study to approve Makena for the prevention of preterm births because it wanted followup data on the children born to women who were on the drug. All of the children of the study participants reached similar developmental targets at 2.5 years of age and again at 5 years of age.

Baxter Pharmaceutical Solutions, maker of Makena, will continue to study the drug to see whether it provides real clinical benefits in terms of better health outcomes to babies who make it to full term.

Pregnant women, though, need to realize that the drug has its limits. It hasn't been shown to be effective at preventing premature births in women who are carrying twins or triplets, says Greene. And it's only approved for those women who had already had a preterm birth.

Some doctors, no doubt, will prescribe it off-label and give it to, say, first-time mothers deemed to be at higher risk of preterm labor. But, adds Greene, the drug may not provide the same level of effectiveness for those at lower risk.

Up to this point, however, the drug has been deemed very safe for both mother and fetus, so women without other options might be willing to give it a try.


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