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FDA Approves Makena™, the First and Only Treatment to Reduce the Risk of Preterm Birth in Women With a Singleton Pregnancy Who Have a History of Singleton Spontaneous Preterm Birth
Date:2/4/2011

rican College of Obstetricians and Gynecologists issued a written opinion in October 2008 stating that, "Progesterone supplementation for the prevention of recurrent preterm birth should be offered to women with a singleton pregnancy and a prior spontaneous preterm birth due to spontaneous preterm labor or premature rupture of membranes." Makena is indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.  

"As an obstetrician specializing in high risk pregnancies and a mom of two, I know that every week of pregnancy counts," said Ashley Roman, M.D., MPH, Clinical Assistant Professor, Department of Obstetrics and Gynecology, NYU Langone Medical Center.  "I have confidence in the safety and efficacy profile of Makena to reduce the risk of another preterm birth for women who are eligible for therapy."

Important Safety InformationMakena should not be used in women with any of the following conditions: current or history of thrombosis or thromboembolic disorders; known or suspected breast cancer, other hormone-sensitive cancer, or history of these conditions; undiagnosed abnormal vaginal bleeding unrelated to pregnancy; cholestatic jaundice of pregnancy; liver tumors, benign or malignant, or active liver disease; or uncontrolled hypertension.

Makena should be discontinued if thrombosis or thromboembolism occurs. Consider discontinuing Makena if allergic reactions occur. Women receiving Makena should be monitored if they are prediabetic or diabetic; have conditions that may be affected by fluid retention, such as preeclampsia, epilepsy, cardiac or renal dysfunction; develop hypertension; or have a history of clinical depression. Makena should be discontinued if depression recurs.

Certain pregnancy-related fetal and maternal complications or events were numerically increased in Makena-treated subjects as compared to placebo subjects, including miscar
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SOURCE K-V Pharmaceutical Company
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