US FDA and health organizations to study safety of medicines taken during pregnancy

5 January 2010

Just prior to 2009 year-end, a new public/private  research program was announced in the USA, called the Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP), which will fund research to study the effects of prescription medicines used during pregnancy. The program is a collaboration among the Food and Drug Administration and researchers at the HMO Research Network Center for Education and Research in Therapeutics (CERT), Kaiser Permanente's multiple research centers and Vanderbilt University.

About two-thirds of women who deliver a baby have taken at least one prescription drug 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, FDA Commissioner, noting that 'These data will guide regulatory policy and influence medical practice."

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