Side Effects of Drugs Used During Pregnancy to be Studied

A collaborative study is being conducted by the FDA, Vanderbilt University, and a number of research centers across the country to examine the effects of prescription medication on pregnant women.

The research program is using health care information on mothers and their children from 11 participating sites, which will give researchers a database of about one million births from a time period of 2001 through 2007. FDA announced the program, known as the Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP) in a statement issued on December 30, 2009.

Officials say that it was necessary to bring together a number of different research centers and databases to compile information on pregnancy and prescription medications because it is considered too dangerous to conduct clinical trials on pregnant women. The lack of information on how prescription drugs affect pregnant women is troubling to some health experts, who estimate that about two-thirds of women who deliver a baby are given at least one prescription medication during their pregnancy.

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

Centers participating in the research program include several Kaiser Permanente centers, Harvard Pilgrim Health Care Institute, Group Health Research Institute, HealthPartners, Lovelace Clinic Foundation, the Meyers Primary Care Institute and Tennessee State Medicaid. The data will be coordinated by the HMO Research Network CERT Data Center at the Department of Population Medicine of the Harvard Medical School and Harvard Pilgrim Health Care Institute.

The project will be overseen by a steering committee of representatives from all of the participating sites and the FDA.