The US Food and Drugs Administration is embarking on a major study of the effect of prescription drugs taken during pregnancy. . The Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP) will be a massive new database-driven study.
For the study, the FDA will collaborate with the HMO Research Network's Center for Education and Research in Therapeutics, based at Harvard Medical School in Boston, and Vanderbilt University in Nashville to collate data from 11 health plan-affiliated research sites.
About two-thirds of women who deliver a baby have taken at least one prescription medication during pregnancy according to a journal article published in the American Journal of Obstetrics and Gynecology. There are very few clinical trials that test the safety of medications in pregnancy due to concerns about the health of the mother and child.
"This program is a great example of FDA and the private sector working together to improve the health of pregnant women and their children," said Margaret Hamburg, MD, Commissioner of Food and Drugs. "These data will guide regulatory policy and influence medical practice."
To overcome the challenges presented by the lack of clinical trial data about the use of medications during pregnancy, the research program will link health care information for mothers and their babies in each of the participating research sites. Collectively, the 11 participating sites have health care information for about 1 million births over the past seven years (2001-2007). 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.
"This collaborative effort creates a unique resource to study the effects of medication in pregnant women and their children," said Gerald Dal Pan, M.D., director of the Office of Surveillance and Epidemiology at the FDA's 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."
The investigators have collaborated on numerous studies related to medication use during pregnancy and birth outcomes, as well as studies on the effects of anti-depressant medications, antibiotics, and cardiovascular medications on birth defects and perinatal outcomes, the agency said in a statement.