Recent studies have linked the fertility drug Clomid (clomiphene) to birth defects in babies born to mothers who took the drug just before or during pregnancy. Birth defects associated with Clomid include heart defects, esophageal atresia and Dandy Walker Malformation of the brain.
Update: Clomid Lawsuit Tossed Over FDA’s Rejection of Birth Defects Warning
March 21, 2016 – A federal judge has rejected allegations made by a woman who claimed that Clomid labels failed to adequately warn about the risk of birth defects, according to Law360. The complaint was filed on behalf of Victoria Cerveny, who says she gave birth to a baby boy with 2 missing fingers after taking Clomid prior to conception. U.S. District Judge Dee Benson said that the U.S. Food & Drug Administration (FDA) had twice rejected a citizen’s petitions claiming that Clomid has a long half-life and inhibits cholesterol biosynthesis, causing birth defects, the same allegation Cerveny made in her complaint.
What’s the problem?
A recent study conducted by the Centers for Disease Control and Prevention (CDC) found a significant correlation between Clomid and at least nine different types of life-threatening birth defects. The research, which was published in the online journal Human Reproduction involved women who took Clomid in the two months leading up to conception and the first trimester of pregnancy. The irony of the study’s findings is that the very medication women are supposed to take to help get pregnant can actually lead to life-threatening birth defects in their babies.
Clomid Birth Defects
- Neural tube defects
- Heart defects
- Skull defects
- Gastrointestinal (GI) defects
- Hyperspadias (opening of the urethra positioned on the upper or superior/dorsal surface of the penis)
- 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)
- Dandy Walker malformation (defect of the brain)
- Cloacal exstrophy (involves multiple abnormalities of the gastrointestinal and genitourinary tracts)
Another study conducted in 2003 by Reefhuis, et al found that expecting mothers who took Clomid had 10 times the risk of giving birth to a child with spina bifida, an extremely severe congenital abnormality in which the backbone and spinal column fail to close before birth.
In 2006, a study conducted by Wu, et al found an incredible 508% increased risk of hypospadias (irregularly placed or missing urethra) in sons of Clomid users.
Another study conducted on 2,339 women who had taken Clomid before or during pregnancy found that nearly 2.5% of cases suffered from birth defects and reproductive complications including stillbirth and spontaneous abortion. This study also linked Clomid to the following birth defects:
- Down’s Syndrome
- Club foot
- Cleft lip and/or cleft palate
- Undescended testes in males
While the percentages for these defects may seem low, the severity of the problems – including life-long disabilities and even premature death – make this a very serious issue. These statistics are particularly devastating to the women and their families who had struggled to become pregnant, and have finally given birth only to find that the fertility drug they were given caused their baby’s birth defect.
How Does Clomid Work?
Hormones are a body’s means of communicating, attaching themselves to receptors in an attempt to pass along a message. When estrogen attaches to the receptor cell in the hypothalamus, it lets the brain know that estrogen levels are increasing. Possessing a structure similar to that of estrogen, Clomid attaches to the receptor cell in the hypothalamus, which prohibits the estrogen from attaching. Because the Clomid is blocking the receptors, the woman’s body is tricked into thinking there is not enough estrogen. In response, the body tries to kick up its production of estrogen by producing more GnRH. This causes the release of FSH, which is what makes the follicles ripen and produce more estrogen. If Clomid works as intended, the body will be tricked into producing more FSH, which causes the body to ovulate. Since it was first approved by the FDA in 1967, Clomid has risen to become the most prescribed fertility drug in the United States.
Clomid Off-Label Uses
Clomid has also been used extensively in an ‘off-label’ capacity (for which it was neither tested nor approved for use by the FDA) in the treatment of secondary hypogonadism. This has been seen by many as a more desirable option to testosterone replacement therapy (TRT) because of the reduced cost and convenience of taking a pill compared to testosterone injections or gels. Unlike traditional TRT, Clomid has not been found to shrink the testicles, and as a result can increase fertility in men.
Clomid Lawsuits Now Being Filed Nationwide
One of the best ways to measure the safety of Clomid is to take note of the numerous birth defect lawsuits being filed nationwide. The FDA’s recognition of these dangers comes on the heels of numerous medical studies linking Clomid to a variety of birth defects, many of which have the potential to be life-threatening. If you or someone you know gave birth to a child with a congenital defect you feel may have been caused by Clomid, use the confidential contact form below or call (866) 588-0600 for a free case evaluation today. Act now – there is a limited amount of time in which to file your claim.