Since 1967, hopeful women have used Clomid when infertility prevented them from having children. However, several studies, including a 2010 study by the U.S. Centers for Disease Control and Prevention, links Clomid to serious and even life-threatening birth defects in children born to mothers who took the drug before or during pregnancy.

What is Clomid?

Clomid, manufactured by Sanofi-Avantis, was initially approved by the FDA in February of 1967. Clomid is a fertility drug used by women who do not produce ova (eggs), but wish to get pregnant. Similar to the natural hormone estrogen, Clomid induces ovulation, causing a woman’s ovaries to release an egg. It belongs to a class of drugs known as ovulatory stimulants and is usually taken in cycles of five days.

Clomid is classified as a Category X drug by the FDA, meaning it is known to cause birth defects. Animals and humans have developed fetal abnormalities in clinical research and there is evidence to suggest human fetuses may be at risk. As a Category X drug, the risks may outweigh the potential benefits.

Clomid Birth Defects Study

According to a 2010 study from the Centers for Disease Control (CDC), Clomid increases the risk of several serious birth defects. The CDC study isn’t the first to link Clomid use to birth defects. A 2010 Harvard study found that ovulation-inducing drugs like Clomid nearly doubled the risk of autism spectrum disorder in children. Other studies pointed to an increased risk of Clomid birth defects such as craniosynotosis and spina bifida.

Additionally, multiple studies have been conducted on mice and rats to determine the effects of Clomid on animals. When clomiphene citrate is given to pregnant rats, it results in a wide range of abnormalities that intensify with stronger doses of the drug. Clomid is associated with low implantation rates of the egg, low fetus weight, and high rates of fetal death. There were also high rates of anencephaly, a condition where the brain is outside the skull.

Other studies suggest that higher doses of Clomid given to pregnant rats resulted in dead fetusus, and difficult or delayed childbirth for mothers. The highest dosages caused maternal mortality, fetal cataracts and fetal cleft palate.

Clomid Birth Defects Risks

Evidence suggests that even after Clomid has successfully fertilized ovulation, it is possible that Clomid remains in the mother’s system well into the initial weeks of pregnancy, which can put the fetus at risk of exposure to a dangerous drug. The CDC study mentioned above identifies the following as serious Clomid birth defects:

• Anencephaly (open cranium with the absence of a brain)
• Esophageal atresia (closed or underdeveloped esophagus)
• Omphalocele (the infant’s intestine or other abdominal organs protrude from the bellybutton)
• Craniosynostosis (premature fusion of the skull bones)
• Dandy Walker Malformation Syndrome (a brain malformation involving the cerebellum and the fluid filled space around it)
• Cloacal exstrophy (involves multiple abnormalities of the gastrointestinal and genitourinary tracts)
• Hypospadias & Penoscrotal Hypospadias (opening of the urethra is on the underside rather than the end)
• Autism Spectrum Disorder (ASD)
• Limb Reduction Deficit (a birth defect in which all or some of the limbs of a fetus do not completely form while in utero)
• Heart defects
• Cleft Pallet

Clomid Lawsuits

Clomid birth defects may require treatment with one or more surgeries, placing a heavy financial burden on the child’s parents. In cases of heart defects, the child may need an initial surgery during their first three years of life, and multiple procedures as they age.

If your child was born with a birth defect after taking Clomid during pregnancy, a product liability lawsuit may provide you with compensation for medical expenses, rehabilitation costs, and other damages. Several Clomid birth defect lawsuits have already been filed, and women who bore children with birth defects may have legal recourse.