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CDC Study Sees Clomid Birth Defect Link

Jun 6, 2011 | Parker Waichman LLP

Evidence of a possible association between Clomid, one of the most popular fertility drugs on the market, and birth defects is growing.  A study published late last year in the journal "Human Reproduction" is just the latest to find a possible association between Clomid and birth defects.

While earlier studies on Clomid and birth defects have been inconclusive, the drug has been assigned to the U.S. Food & Drug Administration (FDA) highest pregnancy risk category - Category X. 

The "Human Reproduction" study was conducted by researchers at the U.S. Centers for Disease Control (CDC).  It consisted of interviews with women throughout the U.S. who had given birth to a child with at least one of 30 birth defects.  They also interviewed mothers of live born infants without a major birth defect.   All of the women in the study had given birth between October 1997–December 2005.

According to the study authors, women who took Clomid  anywhere from two months before conception were more likely to report having had a child with anencephaly, septal heart defects, coarctation of the aorta, esophageal atresia, craniosynostosis, or omphalocele.  A slight increase in children born with Dandy-Walker malformation, muscular ventricular septal defect and cloacal exstrophy was also seen in this group.

According to the "Human Reproduction” article, an estimated 1.6% of U.S. pregnancies are conceived with the use of clomiphene citrate drugs like Clomid, reflecting more than 67 000 exposed pregnancies per year. While the CDC study suffered from some limitations (for example, the study's findings were based on small numbers of women who used Clomid), the authors concluded the frequency of Clomid-exposed pregnancies warrants additional investigations to either confirm or refute their findings.


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