Collaborative program to examine medication safety during pregnancy

About two-thirds of pregnant women have taken at least one prescription medication during pregnancy, yet few clinical trials have examined drug safety in this population. A new program called the Medication Exposure in Pregnancy Risk Evaluation Program will provide funding to explore this unmet need.

Researchers from the FDA, the HMO Research Network Center for Education and Research in Therapeutics at Harvard University, researchers from Vanderbilt University and multiple centers within the Kaiser Permanente network will examine health care information from mothers and their babies at 11 participating research sites. Collectively, these sites encompassed about one million births between 2001 and 2007.

FDA epidemiologist Pamela E. Scott, PhD, will serve as the FDA project lead and will chair a Steering Committee composed of representatives from each participating site that will oversee program activities.

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

Food and Drug Commissioner Margaret Hamburg, MD, added that the program is “a great example of FDA and the private sector working together to improve the health of pregnant women and their children.”