Clomid Study Sees Potential Birth Defect Link

The fertility drug <"">Clomid (clomiphene citrate) may be linked to an increased risk of birth defects, according to a study published last year in the journal “Human Reproduction.” That Clomid study found that mothers who gave birth to children with certain birth defects were more likely to have reported taking Clomid than those who did not.

The birth defects seen in children born to women who reported using Clomid anywhere from two months before conception to the first month of pregnancy included:

• Anencephaly
• Septal heart defects
• Coarctation of the aorta
• Esophageal atresia
• Craniosynostosis
• Omphalocele

In a small number of cases, Clomid was also associated with Dandy-Walker malformation, muscular ventricular septal defect and cloacal exstrophy.

Prior to the publication of the “Human Relations” article, studies examining the association between Clomid and birth defects have been inconclusive. Clomid is classified by the U.S. Food & Drug Administration (FDA) as Pregnancy Category X, showing the highest risk of birth defects when taken during pregnancy

In conducting this study, researchers with the US Centers for Disease Control (CDC) used data from the National Birth Defects Prevention Study, a population-based, multi-site case–control study of major birth defects. Women who conceived using assisted reproductive technology were excluded. Women from 10 US regions with deliveries affected by at least one of 30 birth defects and mothers of live born infants without a major birth defect (controls) who delivered October 1997–December 2005 were interviewed.

While other studies have also found associations between Clomid and many of the birth defects seen by the CDC researchers, this Clomid study marked the first time some – Dandy-Walker malformation, coarctation of the aorta, esophageal atresia, and omphalocele – had been associated with the drug.

The researchers did caution, however, that the study’s findings were based on small numbers of women who used Clomid. They were also unable to ascertain whether the birth defects were the result of Clomid or were caused by some underlying conditions that affected fertility. The authors advised that more studies are needed to better understand any potential link between Clomid and birth defects.

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