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FDA Committee Recommends Premature Birth Drug

By: Lindsay Puccio
By: Lindsay Puccio

August 29, 2006

The advisory committee for the Food and Drug Administration decided to recommend a new drug to help prevent premature births. This drug is something that doctors say is desperately needed. The U.S. premature birth rate grew 12% in the last few years. If the FDA approves this new drug, it could benefit hundreds of thousands of babies born premature every year.

"We find that the rate of preterm labor, that is women delivering before 37 weeks, has actually increased in the past few years," said Dr. Devereux Saller, of the University of Virginia Maternal-Fetal Medicine.

Dr. Saller has seen it happen time and time again.

However, a new drug may help this growing problem.

In clinical trials, Gestiva, has been known to reduce the number of babies born a few weeks early.

"The hope is that it will cause uterine relaxation, where it will relax the womb, helping to prevent preterm labor," explained Dr. Saller.

Injections of the drug are given to pregnant women once a week. In fact, a similar kind of drug is already being used in the University's outpatient clinics.

"It seems to be beneficial for the patients who have received the drug, at least to deliver at a later point in their current pregnancy then they did in a previous pregnancy," said UVA Pharmacy Clinical Specialist Julie Kelsey, PhD.

However, an FDA report shows that may not be enough to approve the drug. The drug doesn't appear to delay the earliest preterm births; those infants born at least two months early, which account for most cases of death and serious health problems.

"The numbers that were looking at in that particular study were just not high enough [and there were] not enough patients in those groups to really evaluate that subgroup well," said Dr. Kelsey.

Considering 500,000 babies are born prematurely every year, the UVA doctors said even if a premature birth for one of those babies is prevented, it would be worth it.

The only thing the FDA committee recommended is more studies to evaluate a possible link between the drug and miscarriages and stillbirths.

It is now up to the FDA to make a final decision in a few days. If the drug is approved, it would be more readily available for pregnant women, and it would encourage insurance companies to start carrying it.


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