December 11, 2009

Project to explore risks of medication exposure on unborn

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Vanderbilt researchers are studying the risks of medication exposure on unborn babies. (Photo by Joe Howell)

Project to explore risks of medication exposure on unborn

Vanderbilt University Medical Center is taking part in a large scale, multi-center effort to assess the risks of medication exposure on unborn babies.

William Cooper, M.D., M.P.H., professor of Pediatrics, has been named principal investigator of a Food and Drug Administration (FDA) collaborative called the Medication Exposure Pregnancy Risk Evaluation Program (MEPREP).

William Cooper, M.D., M.P.H.

William Cooper, M.D., M.P.H.

“It is exciting to work with the FDA and these other sites on this project. It allows us to make connections with investigators across the country to add study power with a large number of pregnancies. This will allow us to look at exposures we would never have been able to study before,” Cooper said.

There are instances when medications are taken during pregnancy, either as prescribed by doctors for an important health concern in the mother, or before a mother is aware she is pregnant.

But these exposures can be accompanied by fear or uncertainty until the baby is born. Exposures, especially those that do not result in any obvious ill effects on the baby, are difficult to track unless there is a large population to draw from.

Cooper said Vanderbilt was selected because of its past participation in large network studies with the FDA.

This type of work began in 1975 with Wayne Ray, Ph.D., professor of Preventive Medicine and director of the Division of Pharmacoepidem-iology, who was joined by Marie Griffin, M.D., M.P.H., professor of Preventive Medicine, in a number of studies based on TennCare records.

Vanderbilt has access to the records through a strictly controlled agreement with the state of Tennessee.

Cooper has been involved in these studies since 1995.

“Because of this previous work we have data reaching back to the 1970s. This gives us great opportunities to make contributions to the network,” Cooper said.

Cooper will look back through records dating back to 2001, and will include the mother's pregnancy records and the records of her child through the first year of life.

Through this system, a great deal of time can be saved when the FDA selects a medication exposure it would like studied, and multiple exposure studies can be requested.