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September 29, 1999

FDA Study finds Possible Link between Down Syndrome and Lower Maternal Folic Acid Levels

Washington (SafetyAlerts) - A study funded by the Food and Drug Administration’s (FDA) Office of Women’s Health and conducted by FDA’s National Center for Toxicological Research (NCTR) has identified possible maternal risk factors for having a child with Down syndrome, a leading genetic cause of mental retardation that occurs in one out of every 700 live births. The preliminary study, published in the American Journal of Clinical Nutrition, found that mothers of children with Down syndrome show biochemical and genetic evidence of impaired folate metabolism.

"This study reflects the agency’s emphasis on state-of-the- art science as the basis for regulatory decisions" said Jane E. Henney, M.D., the Commissioner of Food and Drugs, "and lends additional support for the FDA’s March 1996 decision to require the fortification of certain grain products with folic acid".

Beginning in January 1998, FDA mandated the addition of 140 micrograms of folic acid, a B vitamin, to every 100 grams of certain grain products, such as flour, breakfast cereals, and pasta. This decision based on evidence that inadequate folate status in early pregnancy increases the risk of neural tube defects, was intended to reduce the incidence of birth defects in the brain and spinal cord in this country.

Down syndrome, or trisomy 21, is a complex genetic disease that is caused by an extra copy of chromosome 21. The origin of the extra chromosome is maternal in most cases and is due to an error in chromosome separation before conception. The results of the new study, led by S. Jill James, Ph.D., a biochemist at NCTR, indicated that mothers of children with Down syndrome have an imbalance in folate metabolism that may be explained, in part, by a common genetic variation in an enzyme involved in the folic acid pathway.

It is important to note that while this study may provide some new insights into possible causes of this disease, larger clinical studies will be necessary to confirm the NCTR findings and to definitively determine whether folic acid supplementation, at least 2 months before pregnancy, will reduce the incidence of Down Syndrome.

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