The U.S. Food & Drug Administration (FDA) is ramping up a new research program relevant to soon-to-be mothers and their children. This effort, called the “Medication Exposure in Pregnancy Risk Evaluation Program,” will study the effects of prescription drugs given to women during their pregnancies. Certain drugs can affect or harm the fetus or baby, so pregnant women must consult their doctors before taking any prescription medication.
This study is particularly crucial because research published in the American Journal of Obstetrics and Gynecology (AJOG) shows that 2/3 of women who have a child take at least one prescription during the time in which they are pregnant. It is fairly common that pregnant mothers are unaware of the potential adverse health effects of a drug. They often place their trust in the physician’s expertise and continue to take a particular drug because it comes from a trusted source.
There are very few clinical trials that test medication safety in pregnant women because of fears that there might be adverse effects in those participating. This study works around this issue, using a very large collection of retrospective data to evaluate medication safety without needing to put mother or child at risk. The information this study provides will be useful to both expectant parents and physicians as it will provide more information about the potential hazards of specific common medications. This will allow physicians to more fully obtain informed consent from their patients and allow pregnant women to fully understand the health benefits and risks of their current drug regimens.
This work will be conducted by a collaborative group of researchers at the HMO Research Network Center for Education and Research in Therapeutics, Kaiser Permanent, and Vanderbilt University. The program brings both clinical and research expertise from numerous world-class health centers. Dr. Richard Platt will lead the coordinating center for the program at the HMO Research Network Data Center at the Department of Population Medicine at Harvard Medical School.