Baby in hands | Clomid Lawsuit — inarik/iStock/Thinkstock

A Clomid lawsuit may be an option for mothers who took the fertility drug and had a child born with birth defects. A study correlates the fertility drug clomiphene to birth defects, including those affecting the head and heart. Clomiphene (also known as clomifene) is the active ingredient in the brand name medications Clomid and Serophene. Affected mothers and the families of children born with birth defects may be able to file a Clomid lawsuit and seek compensation with the help of a bad drug attorney.

If you or a loved one took Clomid or Serophene before or during pregnancy and delivered a child with birth defects or other complications, contact Attorney Group today for more information. We provide free, confidential, no obligation consultations. We can help answer your questions, and if you choose to pursue a claim we can connect you with an affiliated Clomid lawsuit attorney who can assist you throughout the legal process.

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What Is Clomiphene?

Clomiphene is used to induce ovulation in women and is in a class of medications called ovulatory stimulants. It works similarly to estrogen, a female hormone that causes eggs to develop in the ovaries and be released. Clomiphene is also prescribed as an off-label medication to men to treat secondary hypogonadism (a condition where the body doesn’t produce enough testosterone). “Off-label” means that the drug has been neither tested nor approved by the FDA for this purpose. Clomiphene is also known by the brand names Clomid and Serophene.

How Does Clomiphene Work?

The hormonal signals that cause ovarian follicles to grow are released from the pituitary gland. The pituitary receives its signals from the hypothalamus in the brain. Clomid blocks the estrogen receptor and tricks the brain into thinking there are low levels of estrogen. The pituitary responds by releasing more hormones, resulting in a stimulation of the follicular growth in the ovaries.

Clomid and Serophene Side Effects

Side effects that may be linked to the use of Clomid include:

Nausea
Risk of multiple pregnancies
Birth defects
Abnormal vaginal bleeding
Breast discomfort
Hot flashes

A study reported on by the Centers for Disease Control and Prevention (CDC) has correlated clomiphene use to serious birth defects, including septal heart defects and muscular ventricular septal defect. The study involved women who reported using the drug in the two months before conception and during the first month of pregnancy and noted that its findings “should be interpreted with caution because they are based on small numbers of women who used clomiphene citrate.”

Clomiphene/Serophene/Clomid Birth Defect Risks

According to the CDC report, mothers of children with the following birth defects said they used clomiphene more often than mothers of children without birth defects:

Septal heart defect: Atrial septal defect (ASD) is a heart defect that is present at birth (congenital). As a baby develops in the womb, a wall (called the interatrial septum) forms that divides the upper chamber into a left and right atrium. An abnormal formation of this wall can result in a hole that remains after birth. This is called an atrial septal defect, or ASD.

Anencephaly: Anencephaly is a condition that prevents the normal development of the brain and the bones of the skull. This condition results when a structure called the neural tube fails to close during the first few weeks of embryonic development.

Coarctation of the aorta: This is a narrowing of the aorta, the large blood vessel that branches off your heart and delivers oxygen-rich blood to your body. When this occurs, your heart must pump harder to force blood through the narrow part of your aorta. Coarctation of the aorta is generally present at birth (congenital). Coarctation of the aorta can range from mild to severe, and might not be detected until adulthood, depending on how narrowed the aorta is.

Esophageal Atresia: Esophageal atresia is a rare birth defect in which a baby is born without part of the esophagus (the tube that connects the mouth to the stomach). About 1 in 4,000 babies in the U.S. is born with esophageal atresia.

Craniosynostosis: This is a birth defect in which one or more of the joints between the bones of a baby’s skull close prematurely, before your baby’s brain is fully formed. When a baby has craniosynostosis, his or her brain can’t grow in its natural shape and the head is misshapen. Craniosynostosis can affect one or more of the joints in a baby’s skull. In some cases, craniosynostosis is associated with an underlying brain abnormality that prevents the brain from growing properly.

Omphalocele: An omphalocele is a birth defect in which an infant’s intestine or other abdominal organs are outside of the body because of a hole in the belly button (navel) area. The intestines are covered only by a thin layer of tissue and can be easily seen.

The CDC also reported that clomiphene was also correlated (in a very small number of cases) with the following birth defects:

Dandy-Walker malformation: Dandy-Walker Syndrome is a congenital brain malformation involving the cerebellum (an area at the back of the brain that controls movement) and the fluid-filled spaces around it. The key features of this syndrome are an enlargement of the fourth ventricle (a small channel that allows fluid to flow freely between the upper and lower areas of the brain and spinal cord), a partial or complete absence of the area of the brain between the two cerebellar hemispheres (cerebellar vermis), and cyst formation near the lowest part of the skull. An increase in the size of the fluid spaces surrounding the brain as well as an increase in pressure may also be present.

Muscular ventricular septal defect: A ventricular septal defect is a birth defect of the heart in which there is a hole in the wall (septum) that separates the two lower chambers (ventricles) of the heart. This wall also is called the ventricular septum. A ventricular septal defect happens during pregnancy if the wall that forms between the two ventricles does not fully develop, leaving a hole. A ventricular septal defect is one type of congenital heart defect.

Other Clomid Side Effects:

According to the FDA, the following are some fetal abnormalities that have been reported subsequent to pregnancies following ovulation induction therapy with Clomid during clinical trials:

Cleft palate
Visual disorders
Club foot
Harelip
Multiple pregnancy
Down syndrome
Spina bifida

Fertility Drugs And Autism

According to a 2010 study conducted by the Harvard School of Public Health, autism was nearly twice as common among the children of women who were treated with “Clomid-type” fertility drugs than women who did not suffer from infertility. A TIME article reporting on the study stated:

“The study, conducted by a team at the Harvard School of Public Health, found that autism was nearly twice as common among the children of women who were treated with the ovulation-inducing drug Clomid and other similar drugs than women who did not suffer from infertility, and the link persisted even after researchers accounted for the women’s age.

A Clomid lawsuit attorney notes that the article also stated that the association between fertility drugs and autism appeared to strengthen with exposure: the longer women reported being treated for infertility, the higher the chances their child had an autism spectrum disorder (ASD).

Has There Been A Clomid Recall?

As of December 2016, there is no known recall of Clomid. The FDA has placed Clomid in the pregnancy Category X, meaning that the drug is contraindicated for use during pregnancy. The agency warns that available data do not suggest an increased risk for congenital anomalies when Clomid is used as indicated. However, animal reproductive toxicology studies showed increased embryo-fetal loss and structural malformations in offspring. If Clomid is used during pregnancy, or if the patient becomes pregnant while taking Clomid, the patient should be appraised of the potential risks to the fetus, the agency reported.

Is There A Clomid Lawsuit or a Serophene Lawsuit?

With the emergence of studies potentially linking Clomid with an increased risk of birth defects in babies exposed to the drug during the early stages of pregnancy, it is expected that a Clomid lawsuit will be filed on behalf of the families of affected children. Contact Attorney Group to learn more.

Clomid and Serophene News

2012 – The FDA issues safety information to include warnings regarding visual disorders ovarian hyperstimulation syndrome, and urticaria.
2012 – The FDA classifies Clomid as a Category X drug, which means that the drug may cause fetal abnormalities. Category X drugs are not meant to be taken by women who are or may become pregnant.
2010 – The CDC reports on a study suggesting that there is a significant correlation between clomiphene and serious birth defects.
2010 – TIME Magazine reports on a Harvard School of Public Health study suggesting that fertility drugs like Clomid nearly doubled the risk for Autism Spectrum Disorder (ASD) in children whose mothers took fertility drugs during pregnancy.

How a Clomid Lawsuit Can Help

Mother And Child | Clomid Lawsuit Attorney — llhedgehogll/iStock/Thinkstock

Drug manufacturers have a duty to ensure their products are accompanied by full and accurate instructions and warnings to guide prescribing doctors and other health care providers in making treatment decisions. If a drug maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.

The parents of children who were born with birth defects linked to Clomid or Serophene may be entitled to compensation for damages, including the child’s:

Medical expenses
Pain, suffering, and mental anguish
Scarring or physical deformities caused by the birth defect or treatment

If a child died due to birth defects linked to Clomid or Serophene, family members may be entitled to compensation for the wrongful death of their loved one, including:

Conscious pain and suffering of their child prior to death
Pain, suffering, and mental anguish from the loss of a child
Funeral expenses

Affected families are encouraged to seek the advice of a Serophene or Clomid lawsuit attorney to learn more about their rights and remedies.