Clomid has helped infertile women conceive children since 1967. Unfortunately, several studies have linked it to a long list of serious and even life-threatening birth defects when mothers take it before or during pregnancy.
Clomid: An Overview
Clomid was approved by the FDA in February 1967 as a fertility drug that induces ovulation in women who no longer release eggs and are trying to get pregnant. Manufactured by Sanofi-Avantis and belonging to a group of drugs known as ovulatory stimulants, Clomid causes a reaction in the body similar to the naturally-occurring estrogen hormone, which encourages the production of ova, or eggs.
Unfortunately, while anxious women took the drug in hopes of becoming pregnant, it may actually cause serious birth defects in babies born to women who used it before becoming pregnant or during pregnancy.
The FDA has labeled Clomid as a Category X drug, the most serious classification of a drug. A Category X label means it has been proven to cause birth defects in either animal or human test subjects. Animals or humans have developed fetal abnormalities during research and there is strong evidence to suggest a human fetus may be at risk.
Due to the severity of the the birth defects associated with Clomid use, you or somebody you know may want to contact a Clomid birth defects lawyer or attorney with The Clark Firm to discuss the potential for a Clomid birth defects lawsuit.
Side Effects of Clomid
Clomid has been associated with a wide range of birth defects, which include:
- Neural tube (spina bifida)
- Heart defects
- Skull defects
- Gastrointestinal defects (omphalocele)
- Cleft lip/palate
- Limb defects
- And more
2010 ‘Human Reproduction’ Clomid Study
The most recent study of Clomid, conducted by the Center for Disease Control and Prevention (CDC) and published in November of 2010 in Human Reproduction, found a connection between Clomid and nine different birth defects:
- anencephaly (parts of brain or skull are missing)
- Dandy-Walker malformation (absence of specific parts of the brain)
- septal heart defects
- muscular ventricular septal defects
- coarctation of aorta (narrowed aorta)
- esophageal atresia (narrowed esophagus)
- cloacal exstrophy (exposed organs)
- craniosynostosis (early closure of skull sutures)
- omphalocele (organs in tissue sac outside of the body).
The women followed in the study were exposed to Clomid or comiphene citrate anywhere between 2 months before pregnancy and through the first month of pregnancy.
Birth Defects in Clomid Clinical Trials
During initial clinical trials, fetal abnormalities were reported in less that 1 percent of users. While rare, these birth defects are serious in nature and could even be life threatening to a baby. They include skull, brain and spinal malformations, holes in the heart and other heart abnormalities, skin disorders, abnormal organ development and even early death.
Clinical tests after Clomid became available on the medical market showed a correlation between the drug and other disturbing birth defects like delayed development, abnormal bone development, dwarfism, deafness, mental retardation, chromosomal disorders, neural tube defects (including anenecephaly), tissue malformations, imperforate anus (blocked opening to the anus), tracheoesophageal fistula (closed esophagus), diaphragmatic hernia, renal agenesis (abnormal development of the kidneys), dysgenesis (abnormal development of an organ), malformations of the eye, ear, lung, heart and genitalia, and skeletal malformations of the skull, face, nasal passages, jaw, hand, lim, foot and joints.
Studies Link Clomid and More Fetal Risks
- A 1991 review showed patients who became pregnant after using Clomid had a spontaneous abortion rate of 16-22%. Another study placed the stillbirth rate at 1.0%.
- A 2003 study found mothers who took Clomid during pregnancy were ten times more likely to give birth to a baby with spina bifida.
Multiple Birth Pregnancies
Not only has Clomid been demonstrated to be dangerous to a mother’s unborn baby, but it is also dangerous to the mother herself. In mothers who used Clomid therapy, they showed a 8-10% chance of conceiving twins, this is compared to a 1-2% chance in the general public.
Multiple pregnancies are automatically considered high risk pregnancies, as there are always additional dangers associated with pregnancies with more than one child. With multiple birth pregnancies there are higher risks of bleeding, miscarriage, increased nausea or vomiting, extreme fatigue, placental problems, iron-deficiency, rapid rise in blood pressure and preterm labor.
Clomid Class Action
The Clark Firm, PLLC is nationally recognized as a class action law firm in Texas. However, our attorneys are not filing a Clomid class action lawsuit against the manufacturers of this drug. Instead, we are filing individual lawsuits on behalf of children with birth defects and their family members.