FDA Panel Backs Drug to Prevent Pre-term Birth

Gestiva most effective before 35th week of pregnancy, researchers say

By Amanda Gardner HealthDay Reporter

Updated on June 12, 2022

WEDNESDAY, Aug. 30, 2006 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel has recommended approval of a drug to help reduce the number of premature babies.

If approved, Gestiva would be the only drug available to help mothers carry their babies to term. The panel has also recommended collecting data if, and when, the drug wins full FDA approval to monitor for any risks or side effects, according to published reports.

The FDA usually follows the recommendations of its advisory committees.

On Tuesday, the FDA's Advisory Committee for Reproductive Health Drugs met to discuss the new drug application for Gestiva, which is made by Adeza Biomedical, based in Sunnyvale, Calif. The drug, a naturally occurring female hormone called progesterone, would be used in women with a history of preterm delivery.

The drug's formulation is available from pharmacies that create custom medications but is difficult to obtain, said Dr. Ashley S. Roman, assistant professor of obstetrics and gynecology at New York University School of Medicine in New York City. "This is a powerful medication that we use a lot in our practice for a small subset of patients," she said.

But Gestiva does have potential drawbacks. It does not, for instance, appear to help prevent the earliest preterm births, which most often result in complications and death. The drug may also increase the rate of miscarriage and stillbirths.

Doctors are taking a cautious approach to a wider and easier availability for the drug.

"Ob/gyns think it's a very promising medication, but for anything that involves pregnant women we're not that aggressive about jumping on the bandwagon," said Dr. Jennifer Wu, an obstetrician/gynecologist at Lenox Hill Hospital in New York City. "Most doctors will have a wait-and-see approach and will probably use it in a select population."

"This is addressing a very legitimate problem that we really have no medication for," Wu added.

Premature babies face a host of neurological, behavioral and other problems, including brain damage.

According to a recent report from the U.S. Institute of Medicine, in 2005, 12.5 percent of all babies born in the United States were born at least three weeks ahead of their delivery date. This represents a 30 percent increase in the rate of preterm births since 1981.

Of all preterm births in the United States, the greatest number are "near-term" or "late-preterm" deliveries -- babies born between 32 weeks and 36 weeks. Although babies born before 32 weeks are at greatest risk for illness and death, all preterm babies face potential problems.

The closer to the expected delivery date the baby is, the lower the chances of problems, especially death.

The FDA first approved Gestiva in 1956 to prevent miscarriages, according to the Associated Press. The agency withdrew approval of the drug in 2000 after the company stopped selling it. New federal law now requires the manufacturer to conduct studies to prove a drug's safety and efficacy.

According to Roman, a U.S. National Institutes of Health study found the drug to be effective before both the 37th week and the 35th week of pregnancy. "There was also an improvement in birth weight," she said.

FDA documents note that the use of this form of progesterone is currently recommended by the American College of Obstetricians and Gynecologists to treat women with a history of preterm birth. It is given via injection starting during the 16th and 20th weeks of pregnancy until the 36th week or birth. The drug does not seem to benefit women if it is started later, or when the signs of preterm birth arise, such as preterm labor or water-breaking.

There is no data on how the drug works in multiple pregnancies, which are a major cause of preterm births.

"There need to be more studies, especially in multiples," Wu said. "These are the patients that are at really high risk. You have to be really careful that you are following the guidelines."

FDA approval could help some physicians breathe easier when they use the drug, one expert said.

Whenever an obstetrician decides to give a medicine to a pregnant woman, the obstetrician runs the risk of whatever liability might be associated with an adverse outcome that could one day be attributed to the drug, explained Dr. F. Sessions Cole, director of newborn medicine and head of the neonatal intensive care unit at St. Louis Children's Hospital. The FDA approval, in addition to making the drug more widely available, also provides some protection against liability.

"These progesterone compounds have been effective in some studies in the past," he continued. "I don't think they're the magic bullet to stop all women from delivering prematurely, but its broader availability and its FDA approval will certainly help reduce the problem."

More information

The March of Dimes has more on premature births.

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