Clomid Use Increases Risk of Serious Birth Defects

(May 1, 2012) – A new study from the Centers for Disease Control (CDC) found that Clomid, a fertility drug made by Sanofi Aventis, significantly increases the risk of serious birth defects. Clomid, also known as clomiphene and clomiphene citrate, is one of the most popular fertility drugs on the market, which works like estrogen to induce ovulation in women who have difficulty conceiving. Clomid is in a class of drugs known as ovulatory stimulants. Another brand name is Serophene.

The new research, which was published in the online journal Human Reproduction, studied women who had used Clomid from two months prior to conception to the first month of pregnancy. Serious birth defects were observed, which included anencephaly (open cranium lacking a brain), esophageal atresia (closed esophagus), omphalocele (abdominal wall defect), craniosynostosis (premature fusion of skull bones), and gastrointestinal and genital defects.

If Clomid is taken during pregnancy, the risks of the following birth defects increase:

~  Congenital heart lesions

~  Muscular ventricular septal defects

~  Down’s syndrome

~  Club foot

~  Cleft lip and/or cleft palate

~  Undescended testes in males

~  Blindness

~  Spina bifida

~  Hernia (inguinal and umbilical)

~  Dandy Walker Malformation

~  Lifelong disability

~  Death

There were earlier studies conducted which also showed a link between Clomid use and birth defects. According to a study conducted at the Harvard School of Public Health in 2010, ovulation-inducing drugs such as Clomid almost doubled the risk of autism spectrum disorder in children. Other studies showed an increase in craniosynostosis and spina bifida defects.

The FDA classifies drugs according to the risk of harm they pose to a fetus in terms of five categories: A, B, C, D, and X.

Categories A and B show no evidence of risk to the fetus.

Category C indicates a possible adverse effect on the fetus, but the drug’s potential benefits may outweigh the risk. Sufficient studies in humans do not yet exist.

Category D shows positive evidence of risk to human fetuses. However, the use of this drug by pregnant women may be warranted in some cases.

Category X is the only category that shows both positive evidence of human fetal risk and the warning that women who are, or could become pregnant, should NOT take this drug. Clomid falls into this category.

(They also have a Category N for drugs that have not yet been classified by the FDA).

Since there are so many birth defect risks associated with the fertility drug Clomid, it is crucial that women be evaluated carefully to exclude pregnancy before each treatment cycle begins. The next course of Clomid therapy should be delayed until pregnancy has been definitively excluded. It is a terrible irony, but the very fertility drug prescribed to help a woman conceive a baby can lead to such serious birth defects, which, in some cases, are fatal. The diagnosis of any of these serious birth defects can be extremely devastating to the mother and family who struggled to become pregnant.  To learn that the fertility drug prescribed to them has caused these abnormalities, or even death of their baby, is so horrific, and someone needs to be held accountable.

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