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March of Dimes: Drug to prevent preterm birth needs prompt FDA approval
August 29, 2006The March of Dimes today urged Food and Drug Administration officials to promptly approve a commercial progesterone therapy that appears to prevent some premature births.
Dr. Nancy Green, March of Dimes medical director, testified before the FDA Advisory Committee for Reproductive Health Drugs, which met to discuss "Gestiva," also known as 17 alpha-hydroxyprogesterone or 17-P.
"Studies of progesterone injections offer promise that the risk of recurrent preterm births will be reduced in a select group of women who already had a baby born too soon," said Dr. Green. "We hope the FDA will approve the licensing of this drug so those women can be helped by this treatment."
Nationwide, nearly a half million babies are born too soon each year and babies who survive face risks of lifelong developmental challenges, such as cerebral palsy, mental retardation, chronic lung disease, and vision and hearing loss. The Institute of Medicine estimates the national cost of premature birth in 2005 exceeded $26 billion.
Progesterone is given as weekly injections during the second half of pregnancy. FDA approval is needed before the drug can be widely available in pharmacies and covered by Medicaid.
Obstetricians who treat women with a high risk pregnancy, such as those with a history of spontaneous preterm birth, often offer progesterone treatments. A 2005 survey found 67 percent of these obstetricians use progesterone compared to 38 percent in 2003.
A large study found that for women who had a previous premature baby 17-P reduced the preterm birth rate by 33 percent compared to a control group. The March of Dimes estimated that if all women eligible for the progesterone therapy had received it, nearly 10,000 premature births might have been prevented in 2003.
While there is no evidence that 17-P has an adverse effect on infants, the March of Dimes remains cautious about its use and is concerned that women without a previous premature baby are receiving the injections.
Dr. Green asked the FDA to monitor the drug for possible adverse effects on infants. She also recommended the FDA direct that, given what is known about its efficacy, Gestiva should only be used by women with a history of spontaneous premature birth.
March of Dimes Birth Defects Foundation
Nationwide, nearly a half million babies are born too soon each year and babies who survive face risks of lifelong developmental challenges, such as cerebral palsy, mental retardation, chronic lung disease, and vision and hearing loss. The Institute of Medicine estimates the national cost of premature birth in 2005 exceeded $26 billion.
Progesterone is given as weekly injections during the second half of pregnancy. FDA approval is needed before the drug can be widely available in pharmacies and covered by Medicaid.
Obstetricians who treat women with a high risk pregnancy, such as those with a history of spontaneous preterm birth, often offer progesterone treatments. A 2005 survey found 67 percent of these obstetricians use progesterone compared to 38 percent in 2003.
A large study found that for women who had a previous premature baby 17-P reduced the preterm birth rate by 33 percent compared to a control group. The March of Dimes estimated that if all women eligible for the progesterone therapy had received it, nearly 10,000 premature births might have been prevented in 2003.
While there is no evidence that 17-P has an adverse effect on infants, the March of Dimes remains cautious about its use and is concerned that women without a previous premature baby are receiving the injections.
Dr. Green asked the FDA to monitor the drug for possible adverse effects on infants. She also recommended the FDA direct that, given what is known about its efficacy, Gestiva should only be used by women with a history of spontaneous premature birth.
March of Dimes Birth Defects Foundation
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Management of asthma during pregnancy can optimize health of mother and baby
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Preterm Birth: Causes, Consequences, and Prevention by Committee on Understanding Premature Birth and Assuring Healthy Outcomes (Author), Richard E. Behrman (Editor), Adrienne Stith Butler (Editor) The increasing prevalence of preterm birth in the United States is a complex public health problem that requires multifaceted solutions. Preterm birth is a cluster of problems with a set of overlapping factors of influence. Its causes may include individual-level behavioral and psychosocial factors, sociodemographic and neighborhood characteristics, environmental exposure, medical conditions, infertility treatments, and biological factors. Many of these factors co-occur, particularly in those who are socioeconomically disadvantaged or who are members of racial and ethnic minority groups. While advances in perinatal and neonatal care have improved survival for preterm infants, those infants who do survive have a greater risk than infants born at term for developmental disabilities, health... |
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Neurodevelopmental Outcomes of Preterm Birth: From Childhood to Adult Life by Chiara Nosarti (Editor), Robin M. Murray (Editor), Maureen Hack (Editor) The improved survival of very preterm and very low birth weight infants in recent decades has been associated with an increase in the prevalence of physical and neurodevelopmental problems. Attention is increasingly being focused on the quality of life of survivors, who are at greater risk of brain damage and consequent neurological disorders, and neuropsychological and behavioural impairments. In this volume, leading experts present a comprehensive and up-to-date perspective on research in various aspects of the long-term consequences of very preterm birth. As well as extending existing knowledge of the neurodevelopmental sequelae following very preterm birth, a shared aim of this burgeoning body of research is to identify the mechanisms underlying variations in outcome, and thus... |
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Preterm Birth: Mechanisms, Mediators, Prediction, Prevention & Interventions (Series in Maternal Fetal Medic) by Felice Petraglia (Editor), Jerome F. Strauss III (Editor), Steven G. Gabbe (Editor), Gerson Weiss (Editor) Preterm delivery is probably the most important problem in obstetrics, and a major public health concern. Recent developments - such as the preventive use of progesterone, and new data on possible mechanisms of initiation of parturition – have placed the topic at the forefront of the interests and preoccupation of many in maternal-fetal medicine and obstetrics. Recent studies have found that preterm deliveries have increased even amongst low risk women. Also shown is that assisted conceptions, multiple pregnancies and elective deliveries are associated with early birth. The impact on society is considerable. Preterm birth can also have considerable impact on long-term health, including severe mental or physical disability. With all this being currently debated,... |
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Studies back progesterone injections to prevent preterm birth.(Women's Health): An article from: Family Practice News by Sherry Boschert (Author) This digital document is an article from Family Practice News, published by Thomson Gale on October 1, 2005. The length of the article is 584 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Amazon.com Digital Locker immediately after purchase. You can view it with any web browser. Citation Details Title: Studies back progesterone injections to prevent preterm birth.(Women's Health) Author: Sherry Boschert Publication: Family Practice News (Magazine/Journal) Date: October 1, 2005 Publisher: Thomson Gale Volume: 35 Issue: 19 Page: 64(1) Distributed by Thomson... | |
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Medicolegal issues in preterm birth of multiples.(Obstetrics): An article from: OB GYN News by Sherry Boschert (Author) This digital document is an article from OB GYN News, published by Thomson Gale on March 1, 2006. The length of the article is 680 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Amazon.com Digital Locker immediately after purchase. You can view it with any web browser. Citation Details Title: Medicolegal issues in preterm birth of multiples.(Obstetrics) Author: Sherry Boschert Publication: OB GYN News (Magazine/Journal) Date: March 1, 2006 Publisher: Thomson Gale Volume: 41 Issue: 5 Page: 11(1) Distributed by Thomson... | |
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