FDA Approves Progesterone Injections to Prevent Premature Birth
February 9, 2011
Good news in the fight against preterm births (of which there are more than half a million each year in the U.S.): just last week, the FDA approved the use of hydroxyprogesterone caproate injection, commonly known as 17P, which is a synthetic form of a hormone produced during pregnancy. The drug will be marketed under the brand name Makena™ and given in weekly injections to pregnant women between 16 and 20 weeks gestation, continuing until 37 weeks. According to a published study by the March of Dimes, the National Institutes for Health, and the Centers for Disease Control and Prevention, nearly 10,000 spontaneous premature births might be prevented annually if all women eligible for the progesterone injections received them.
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Since 2003, the American Congress of Obstetricians and Gynecologists has recommended that doctors offer progesterone treatments (injections or vaginal suppositories, depending on the patient’s risk factors for preterm birth) to high-risk women, but prior to the approval of Makena, health care providers had to order prescriptions of 17P from specialized compounding pharmacies, which created logistical and financial barriers to access for many eligible patients. FDA approval means that the drug will now be widely available in specialty pharmacies and that access to it through healthcare coverage will be improved. However, vaginal progesterone suppositories still do not have FDA approval, although some doctors may choose to prescribe them “off-label” in women with certain risk factors for preterm birth, like a short cervix.
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Hydroxyprogesterone caproate injection is only approved for use by women who have already had a baby born before 37 weeks, and who are pregnant with one baby. "For the first time, we have an FDA-approved treatment to offer women who have delivered a baby too soon, giving them hope that their next child will have a better chance at a healthy start in life," said Alan Fleischman, MD, senior vice president and medical director of the March of Dimes, in a press release. "Women who already have had a baby born prematurely should check with their health care provider to see if this treatment is appropriate for them."
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