FDA and Health Organizations to Study Safety of Medications Taken During Pregnancy

The Medication Exposure in Pregnancy Risk Evaluation Programme (MEPREP) is a new research programme that intends to support research on studying the effects of using prescription medicines during pregnancy. MEPREP will work alongside the U.S. Food and Drug Administration and researchers from the HMO Research Network Center for Education and Research in Therapeutics (CERT) and research centers from Kaiser Permanente and Vanderbilt University.

A recent article published in the American Journal of Obstetrics and Gynaecology states that around two-thirds of women while being pregnant take at least one prescription medication. With the use of medication during pregnancy as an appropriate safety measure only tested in a handful of clinical trials, it should be addressed, as the health of both mother and child is a cause for concern.

Margaret Hamburg, MD, Commissioner of Food and Drugs said, “This program is a great example of FDA and the private sector working together to improve the health of pregnant women and their children. This data will guide regulatory policy and influence medical practice.”
MEPREP’s strategy incorporates the sharking of healthcare information for mothers and babies in every single research site participating in the programme. This will aid to counter the deficiency of clinical trial data regarding the utilization of medication during pregnancy.

Currently, around eleven participating websites contain information for over one million births from 2001-2007, with a large number of these mothers having used prescription medication while being pregnant. With the new programme in place, the FDA says retrieving relevant information from the network is far more efficient and makes the research process easier and more accurate.

“This collaborative effort creates a unique resource to study the effects of medication in pregnant women and their children. Results of these studies will provide valuable information for patients and physicians when making decisions about medication during pregnancy,” says Gerald Dal Pan, M.D., director of the Office of Surveillance and Epidemiology at the FDA’s Center for Drug Evaluation and Research.