FDA Approval of Drug to Prevent Pre-term Births Considered

A Food and Drug Administration advisory panel is considering the approval of a new drug that would help prevent the risk of premature births, thus decreasing potential birth complications such as cerebral palsy.

Upon FDA approval, Gestiva could become the only drug that would help mothers have a full term pregnancy. Currently, Gestiva is available in pharmacies that formulate custom medications, but it is very hard for women to obtain, according to Dr. Ashley S. Roman, an assistant professor of gynecology and obstetrics at New York University School of Medicine.

Premature Births Linked to Serious Complications

Research has found that pre-term births are strongly associated with severe neurological and behavioral problems, including brain damage, cerebral palsy, attention deficit hyperactivity disorder, and even death.

According to a U.S. Institute of Medicine report, about 12.5 percent of all infants born in the United States in 2005 were born a minimum of three weeks ahead of the due date—a 30 percent jump from the rate of premature births since 1981.

The FDA Advisory Committee for Reproductive Health Drugs' consideration to approve the widespread use of Gestiva is a step toward addressing a serious reproductive issue.

“This is addressing a very legitimate problem that we really have no medication for,” said Dr. Jennifer Wu, a New York obstetrician/gynecologist.

History of Gestiva

The FDA first approved Gestiva, manufactured by Adeza Biomedical, in 1956 to help prevent miscarriages. However, the drug was taken off the market in 2000 due to some safety concerns.

The drug has been linked to increased rates of stillbirths and miscarriages and does not appear to prevent early preterm births, which typically result in serious problems and death. New federal regulations require the drug makers to conduct health studies in order to evaluate the efficacy and safety of Gestiva.

Furthermore, there is little information on how Gestiva works on multiple pregnancies, which are a significant factor in preterm births. “There need to be more studies, especially in multiples,” said Wu. “These are the patients that are at really high risk. You have to be really careful that you are following the guidelines.”

The FDA will continue to discuss Gestiva's approval process.

Did your child suffer a birth injury? If so, contact a cerebral palsy attorney to discuss your child's legal rights.