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Robin Elise Weiss, LCCE

Makena Approved to Treat Preterm Labor

By February 7, 2011

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Premature infant nicu

The FDA has approved Makena™ (hydroxyprogesterone caproate injection), formerly known as 17P, to reduce the risk of preterm birth.  Makena™ is the only treatment that is FDA approved.  Women who are eligible for Makena™ are moms who are carrying only one baby and have a history of a preterm birth.  While this is only a certain portion of moms who experience preterm labor, it is still helpful.

These shots are begun between 16-20 weeks and done every 7 days until delivery or 37 weeks, which ever comes first.

You should not take Makena™ if:

  • current or history of thromoembolic disorders or thrombosis
  • known or suspected breast cancer
  • cholestatic jaundice of pregnancy
  • live tumors or disease
  • other hormone-sensitive cancers
  • undiagnosed abnormal vaginal bleeding not related to pregnancy
  • others.

"Preterm birth is a national healthcare crisis. The approval of this new treatment is a breakthrough in our fight against preterm birth," said Alan R. Fleischman, M.D., Medical Director, March of Dimes.  "Although the United States has made great progress in caring for premature babies, there is no greater advance than allowing a baby to mature in a mother's womb."

There are also side effects related to Makena™, most commonly at the site of the shot.  Other side effects included nausea and diarrhea.  However, there were also complications associated with Makena™ users versus the controls in the study.  This can include higher rates of miscarriage, stillbirth, preeclampsia, gestational diabetes and oligohydramnios (low amniotic fluid), to name a few.

This is obviously something to talk to your doctor about the risks versus the benefits.  Preterm birth has an amazing impact on the health of the babies born early as well as the families.  The March of Dimes estimates that if every one who was eligible to take this treatment did so, we'd have about 10,000 fewer preterm births every year.

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