Yenra : Health : Women's Health : FDA funds research on prescription medications used by pregnant women

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FDA in partnership with the Office of Women's Health, U.S. Department of Health and Human Services (DHHS), today announced the award of two contracts to study prescription medications used by pregnant women. These contracts are for research on two drugs--labetalol and atenolol--used by pregnant women to treat their high blood pressure (hypertension). The contracts are the first in a series to assess treatments commonly used by pregnant women.

The awards were made to the University of Illinois at Chicago to determine the appropriate doses and effects of labetolol for treating hypertension in pregnant women and the University of Washington for similar studies of atenolol in pregnant women.

FDA is funding the research to identify the doses that will provide the greatest benefit and least risk for the mother and her baby. The studies will evaluate the medications already being used by the pregnant women in the study.

FDA is funding the research because pregnant women with hypertension commonly use both of these drugs, even though little clinical data is currently available on this patient population. In fact, this situation is true of many medications that may be used by pregnant women.

A study conducted in l994 by FDA found that the average number of prescriptions during pregnancy was three for each patient (excluding prenatal vitamins, iron preparations, and medications at the time of delivery). The number of prescriptions increased with age; for example, pregnant women over the age of 35 were taking an average of five prescriptions (unpublished data, FDA). Information needed to guide drug dosing in pregnant women is rarely collected.

Both of the study centers involved in the labetol and atenolol studies are members of the DHHS National Centers of Excellence in Women's Health. These centers were established by the U.S. Public Health Service's Office of Women's Health in l996 as models for health care for women. The DHHS National Centers of Excellence in Women's Health provide a direct mechanism for HHS agencies to fund Women's health research at premier academic institutions.

These studies must follow all ethical and patient protection regulations and should demonstrate that this type of study can and should be done for medications widely used during pregnancy.