Clomid

Clomid Study Sees Potential Birth Defect Link

Date Published: Wednesday, September 7, 2011

Clomid, a popular fertility drug, may increase the risk of birth defects. Up until now, studies examining the association between Clomid and birth defects have been inconclusive, but new research just published online in the journal Human Reproduction has found a significant association with nine types of birth defects following use of Clomid.

Clomid is the brand name for the fertility drug clomiphene citrate. Clomiphene citrate may also be sold under the brand name Serophene. Clomid, the most commonly prescribed fertility drug, is used to induce ovulation (egg production) in women who do not produce ova (eggs) but wish to become pregnant. Clomid is in a class of medications called ovulatory stimulants, according to the National Center for Biotechnology Information. It works similarly to estrogen, a female hormone that causes eggs to develop in the ovaries and be released.

To conduct this latest Clomid birth defects 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 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. The exposure of interest was reported Clomid use in the period from 2 months before conception through the first month of pregnancy. Women who conceived using assisted reproductive technology were excluded.

Thirty-six birth defect categories with at least three exposed cases were studied. Birth defects seen in the study included anencephaly (open cranium with absence of a brain), esophageal atresia (closed esophagus), omphalocele(protrusion of part of the intestine through the abdominal wall), craniosynostosis (premature fusion of the skull bones), 3 different types of heart defects and a defect of the brain (Dandy Walker malformation). The ninth defect (cloacal exstrophy) involves multiple abnormalities of the gastrointestinal and genitourinary tracts.

Twenty-two of the remaining 27 birth defect categories likewise showed an increased risk, ranging from 10 percent up to 170 percent after exposure to Clomid, although the study authors said the numbers were insufficient to reach the scientific standard for statistical significance.  Though the researchers noted that the associations seen in this latest study should be interpreted cautiously, it is not the first to point to possible link between birth defects and Clomid. For example, a May 2010 study out of the Harvard School of Public Health, reported that the use of ovulation-inducing drugs (including Clomid) almost doubled the risk of autism spectrum disorder (ASD) in children. Meanwhile, a 2003 study (Reefhuis, et al) found a 280 percent increased risk of craniosynostosis; while another published in 2006 (Wu, et al) found a 10-fold increased risk in spina bifida. A separate 2006 article (Meijer, et al) found a 508 percent increased risk of penoscrotal hypospadias.

According to a study published in the online journal Human Reproduction there is significant relation between Clomid, a fertility drug, and nine types of birth defects. The study was conducted by the US Centers for Disease Control (CDC) and involved women who reported Clomid use in the period of two months before conception and the first month of pregnancy. The birth defects associated with Clomid are serious, and some are life threatening. The terrible irony is that the very drug supposed to help women have babies can lead to crippling birth defects.

Serious birth defects seen in the CDC study include

* Anencephaly (open cranium with the absence of a brain)
* Esophageal atresia (closed esophagus)
* Omphalocele (protrusion of part of the intestine through the abdominal wall)
* Craniosynostosis (premature fusion of the skull bones)
* Three different types of heart defects
* Dandy Walker malformation (defect of the brain)
* Cloacal extrophy (involves multiple abnormalities of the gastrointestinal and genitourinary tracts)

A 2003 study (Reefhuis, et al) also linked Clomid to birth defects and found that mothers who took Clomid had ten times the risk of giving birth to an infant with spina bifida.

In 2010, the Harvard School of Public Health reported that the use of ovulatory stimulants like Clomid almost doubled the risk of autism spectrum disorder in children. A 2006 study (Wu, et al) indicated an astonishing 508% increased risk of penoscrotal hypospadias (irregularly placed or missing urethra) for sons of women who took Clomid before or during pregnancy.

Another study conducted on 2,339 Clomid-assisted pregnancies found about 2.4% of cases experienced Clomid birth defects and reproductive complications including spontaneous abortion and stillbirth. While the percentage seems low, the severity of the defects, including life-long disability and fatality, makes this a very serious issue. Additional defects that were found by this study to correlate with Clomid usage:

* Down’s Syndrome
* Club foot
* Cleft lip and/or cleft palate
* Undescended testes in males
* Blindness
* Hernia
* Malformations

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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