Sunday, February 6, 2011

New Preterm Birth Drug Approved

I have not had a pre-term birth, but I have had some scares. It sounds like I wouldn't be eligible for this drug because my kids were all born at term(not that I need any more kids!) If there are no dangers to the baby, I say GREAT! It is certainly a scary thought to think your baby is trying to come out early. I was given magnesium-sulfate to stop my contractions with my second (28 weeks.) My contractions stopped and I went on to deliver at 39 weeks. What do you think about the fast approval of this drug? I do wonder, why now?

FROM NBC: The Food and Drug Administration has approved a drug to reduce the risk for preterm birth. The drug is called Makena. It's given once a week as a shot in the hip beginning between 16- and 22-weeks gestation. It's only intended for women at risk of delivering before week 37 of pregnancy and for women carrying single babies, rather than multiples. Makena was given fast-track status and the manufacturer will be required to conduct additional long-term studies for safety and effectiveness. The March of Dimes released a statement applauding the drug's approval.

FROM BUSINESS WEEK: "The most common risk factor for preterm birth is recurrence," said Dr. Alan Fleischman, March of Dimes senior vice president and medical director. "This is the first approved drug to prevent recurrence for women who have had a singleton preterm baby and now have a singleton baby," he added. "That will dramatically [lower the] rate for those women."

Hydroxyprogesterone caproate has not been without some controversy. In 2006, an FDA advisory committee considering hydroxyprogesterone caproate to treat preterm birth brought up safety concerns, including a possible association with second trimester miscarriages.

Hydroxyprogesterone caproate is also the same drug as a much older one called Delalutin, which was approved by the FDA in 1956 and was used to treat female hormone disturbances and cancer, but withdrawn from the market for business reasons in 2008, the agency says.

"Makena is chemically the same as Delalutin," Burgess said.

What is new here is that a drug company will be making the drug; it won't have to be made up in pharmacies, according to Fleischman. "There will be consistency and high quality. This makes it a breakthrough not only that it's FDA approved and doctors will be comfortable in recommending it, but also there will be high quality and consistency for women as they take it," he said.

-NewsAnchorMom Jen

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