FDA announces collaborative effort to gauge safety of drugs taken during pregnancy

January 5, 2010 by Shawn Douglas
Filed under: News, Pregnancy

The US Food and Drug Administration (FDA) announced a major effort to better understand the safety of drugs taken during pregnancy.

Due to a lack of scientific research into the effects of drugs on pregnant women, the U.S. FDA said last week it would collaborate with other researchers under a new program called Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP). The collaboration will include staff from the FDA, Vanderbilt University, Kaiser Permanente, and the HMO Research Network Center for Education and Research in Therapeutics (CERT).

The FDA estimates that nearly two out of every three women who have delivered a baby have taken at least one type of prescription medication during the pregnancy.

Multiple studies will be conducted, focusing on data collected on nearly one million births between 2001 and 2007 from the participating eleven research centers.

“Many of the mothers associated with these births likely used medication during their pregnancies and now, with the program in place, the FDA and participating researchers have a systematic and timely way of retrieving information from this network,” said an FDA spokesperson.

“These data will guide regulatory policy and influence medical practice,” added FDA Commissioner Dr. Margaret Hamburg in a news release to WebMD.

The information collected from the study of the data will be maintained at both the CERT Data Center at the Department of Population Medicine of Harvard Medical School and the Harvard Pilgrim Health Care Institute. The researchers will mine for data, analyzing for correlations between prescription drug use and birth outcomes.

“Results of these studies will provide valuable information for patients and physicians when making decisions about medication during pregnancy,” said Dr. Gerald Dal Pan, Director of the Office of Surveillance and Epidemiology at the FDA’s Center for Drug Evaluation and Research.

No timetable is set for the completion of the program and the release of its results.