Featured Research

from universities, journals, and other organizations

March Of Dimes: Drug To Prevent Preterm Birth Needs Prompt FDA Approval

Date:
August 30, 2006
Source:
March of Dimes Birth Defects Foundation
Summary:
The March of Dimes is urging the U.S. Food and Drug Administration officials to promptly approve a commercial progesterone therapy that appears to prevent some premature births.

The March of Dimes is urging the U.S. 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.

The March of Dimes works to improve the health of babies by preventing birth defects, premature birth and infant mortality. For more information, visit marchofdimes.com or nacersano.org for Spanish.


Story Source:

The above story is based on materials provided by March of Dimes Birth Defects Foundation. Note: Materials may be edited for content and length.


Cite This Page:

March of Dimes Birth Defects Foundation. "March Of Dimes: Drug To Prevent Preterm Birth Needs Prompt FDA Approval." ScienceDaily. ScienceDaily, 30 August 2006. <www.sciencedaily.com/releases/2006/08/060829080455.htm>.
March of Dimes Birth Defects Foundation. (2006, August 30). March Of Dimes: Drug To Prevent Preterm Birth Needs Prompt FDA Approval. ScienceDaily. Retrieved July 23, 2014 from www.sciencedaily.com/releases/2006/08/060829080455.htm
March of Dimes Birth Defects Foundation. "March Of Dimes: Drug To Prevent Preterm Birth Needs Prompt FDA Approval." ScienceDaily. www.sciencedaily.com/releases/2006/08/060829080455.htm (accessed July 23, 2014).

Share This




More Health & Medicine News

Wednesday, July 23, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Courts Conflicted Over Healthcare Law

Courts Conflicted Over Healthcare Law

AP (July 22, 2014) Two federal appeals courts issued conflicting rulings Tuesday on the legality of the federally-run healthcare exchange that operates in 36 states. (July 22) Video provided by AP
Powered by NewsLook.com
Why Do People Believe We Only Use 10 Percent Of Our Brains?

Why Do People Believe We Only Use 10 Percent Of Our Brains?

Newsy (July 22, 2014) The new sci-fi thriller "Lucy" is making people question whether we really use all our brainpower. But, as scientists have insisted for years, we do. Video provided by Newsy
Powered by NewsLook.com
Scientists Find New Way To Make Human Platelets

Scientists Find New Way To Make Human Platelets

Newsy (July 22, 2014) Boston scientists have discovered a new way to create fully functioning human platelets using a bioreactor and human stem cells. Video provided by Newsy
Powered by NewsLook.com
Gilead's $1000-a-Pill Drug Could Cure Hep C in HIV-Positive People

Gilead's $1000-a-Pill Drug Could Cure Hep C in HIV-Positive People

TheStreet (July 21, 2014) New research shows Gilead Science's drug Sovaldi helps in curing hepatitis C in those who suffer from HIV. In a medical study, the combination of Gilead's Hep C drug with anti-viral drug Ribavirin cured 76% of HIV-positive patients suffering from the most common hepatitis C strain. Hepatitis C and related complications have been a top cause of death in HIV-positive patients. Typical medication used to treat the disease, including interferon proteins, tended to react badly with HIV drugs. However, Sovaldi's %1,000-a-pill price tag could limit the number of patients able to access the treatment. TheStreet's Keris Lahiff reports from New York. Video provided by TheStreet
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins