US FDA to study safety of medicines taken during pregnancy
A new research programme called the Medication Exposure in Pregnancy Risk Evaluation Programme (MEPREP) is to fund research into the effects of prescription drugs taken during pregnancy.
A new research programme called the Medication Exposure in Pregnancy Risk Evaluation Programme (MEPREP) is to fund research into the effects of prescription drugs taken during pregnancy.
The US Food and Drug Administration (FDA) and researchers at the HMO Research Network Centre for Education and Research in Therapeutics (CERT), Kaiser Permanente's multiple research centres and Vanderbilt University are to collaborate in the programme.
About two-thirds of women who have a baby take at least one prescription drug during pregnancy according to the American Journal of Obstetrics and Gynecology. However, only a small number of clinical trials test the safety of drugs taken during pregnancy because of concerns about the health of the mother and child.
To overcome the challenges presented by such a lack of clinical trial data, the research will link healthcare information for mothers and their babies in 11 participating research sites, which collectively have healthcare information for about one million births over seven years (2001-2007). Many of the mothers were likely to have used medication during their pregnancies and now the FDA and participating researchers have a systematic way of retrieving information from this network.
"Results of these studies will provide valuable information for patients and physicians when making decisions about medication during pregnancy," said Gerald Dal Pan, director of the Office of Surveillance and Epidemiology at the FDA's Centre for Drug Evaluation and Research.
A Steering Committee composed of representatives from each participating site and the FDA will oversee MEPREP activities and provide overall scientific leadership. FDA epidemiologist Pamela Scott is the FDA project lead and chair of the Steering Committee.