FDA To Study Safety Of Drugs Taken By Women While Pregnant

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Main Category: Pregnancy / Obstetrics
Also Included In: Regulatory Affairs / Drug Approvals;  Pediatrics / Children's Health
Article Date: 05 Jan 2010 - 2:00 PDT

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The US Food and Drug Administration (FDA) is funding a new programme to study the effects of prescription drugs taken by women while they are pregnant.

The federal agency announced on 30 December that it was setting up a new research programme called the Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP) in collaboration with the HMO Research Network Center for Education and Research in Therapeutics (CERT), Kaiser Permanente and Vanderbilt University.

Because of concerns for the health of pregnant women and their unborn children, few clinical trials have tested the safety of drugs in pregnancy, yet according to an article published in the American Journal of Obstetrics and Gynecology, about two-thirds of American women who give birth have taken at least one prescription drug during their pregnancy, reported the FDA.

One way to overcome this predicament is to gather as much information as possible on the health of mothers and babies from cases where the mother took prescribed drugs during pregnancy.

Between them, 11 sites participating in MEPREP will have healthcare information on about 1 million births covering seven years from 2001, said the FDA. In many of these cases the mothers will have used prescribed medication while pregnant, and the program should be able to mine useful research data from the records.

Director of the Office of Surveillance and Epidemiology at the FDA's Center for Drug Evaluation and Research (CDER), Dr Gerald Dal Pan told the media that:

"Results of these studies will provide valuable information for patients and physicians when making decisions about medication during pregnancy."

The 11 health-plan affiliated sites involved in the program are the FDA and:

• Kaiser Permanente (Northern California, Southern California, Georgia, Pacific Northwest, and Colorado regions).
• Harvard Pilgrim Health Care Institute.
• Group Health Research Institute.
• HealthPartners, Lovelace Clinic Foundation.
• Meyers Primary Care Institute.
• Tennessee State Medicaid.

The program will be coordinated by the HMO Research Network CERT Data Center at the Department of Population Medicine of Harvard Medical School and Harvard Pilgrim Health Care Institute.

All the lead investigators at the 11 centers have been involved on several studies linked to use of medication in pregnancy and birth outcomes, said the FDA. They have also worked on research looking at the effect of anti-depressants, antibiotics, and cardiovascular drugs on birth defects and birth outcomes.

The FDA did not say when the studies would be completed or when any interim or final reports might be available.

Source: FDA.

Written by: Catharine Paddock, PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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