Children of women who have used the fertility treatment Clomiphene, also known as clomifene and distributed under the names Clomid and Serophene, may have a greater risk of developing certain birth defects, including defects affecting the head and the heart. Mothers and families of affected children may be eligible to pursue compensation with the help of a Tennessee Clomid lawsuit attorney.
For more information, contact Attorney Group for Tennessee today. Our consultations are free, confidential and without any obligation on your part. We can help answer your questions, and if you choose to pursue a claim we can connect you with an affiliated attorney who can assist you throughout the legal process.
What is Clomiphene?
Clomiphene citrate is the active ingredient in the fertility drug Clomid, a commonly used medication used to stimulate and trigger ovulation. Despite the effectiveness of the medication to treat infertility, there have been a variety of side effects and risks associated with its use. Examples of Clomiphene risks and side effects include nausea, multiple pregnancies, birth defects, abnormal vaginal bleeding, breast discomfort, and hot flashes.
How Does Clomiphene Work?
Clomiphene works by blocking the estrogen receptors in the hypothalamus, a portion of the brain that controls the production of hormones. Follicle stimulating hormone (FSH) and luteinizing hormone (LH) are then released by the hypothalamus to induce ovulation. Clomiphene may also be used as an off-label medication to treat an absence of testosterone production in men known as hypogonadism. “Off-label” use of clomiphene has been neither tested nor approved by the U. S. Food and Drug Administration (FDA) to treat male infertility.
Clomiphene Birth Defect Risks
Using data from the National Birth Defects Prevention Study (NBDPS), a study reported on by the Centers for Disease Control and Prevention (CDC) and published in the journal Human Reproduction indicated a correlation between a small number of women who used Clomiphene to treat infertility and serious congenital birth defects. Birth defects affecting those children include defects that affect the head, heart, and limbs of the child (Reefhuis, Honein, Schieve, Rasmussen, and NBDPS).
Findings of the study indicate that children of mothers who used Clomiphene encountered the following problems in greater numbers than children of mothers who did not use the fertility treatment:
- Prior birth defects correlated with Clomiphene treatment include neutral tube defects (NTDs), hypospadias, and craniosynostosis
- Significant associations between Clomiphene and anencephaly (unusual brain and skull development), Dandy-Walker malformation (brain malformation of the cerebellum), septal heart defects (unusual connection between the lower ventricles of the heart), muscular ventricular heart defects (hole in the wall of the heart’s lower chambers), coarctation of the aorta (narrowing of the aorta), esophageal atresia (underdeveloped esophagus), and cloacal extrophy (unusual position of the large intestine)
These and other serious birth defects could require one or more surgeries to treat the condition, often resulting in large medical costs to the child’s parents and family. In addition to initial surgical approaches, the child may need multiple medical procedures during the first three years of their life, especially in the case of those birth defects affecting the lower chambers of the heart.
Fertility Drugs and Autism
In a report to attendees at the International Meeting for Autism Research in Philadelphia, researchers from the Harvard School of Public Health indicated that women who used fertility treatment to induce ovulation had nearly double the risk of having a child with autism spectrum disorder (ASD). In an article published in Time magazine, the correlation between fertility drugs such as Clomid and ASD appeared to escalate with exposure. The chances of a child whose mother had treated infertility with ovulation medication increased with longer use.
Other Clomid Side Effects
According to the FDA, other side effects have been reportedly linked to pregnancies following ovulation induction therapy with Clomid during clinical trials:
- Cleft palate
- Visual disorders
- Club foot
- Multiple pregnancy
- Down syndrome
- Spina bifida
How a Tennessee Clomid Lawsuit Can Help
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.
Patients who are injured by Clomid may be entitled to compensation for damages, including:
- Medical expenses
- The permanency of the injury
- Pain, suffering, and mental anguish
- Loss of income or ability to work
If a patient dies from complications after taking Clomid, family members may be entitled to compensation for the wrongful death of their loved one, including:
- Conscious pain and suffering of a loved one prior to death
- Pain, suffering, and mental anguish from the loss of a loved one
- Funeral expenses
Patients who have suffered severe side effects after taking Clomid, as well as the families of those who have died as a result of complications with the drug, are encouraged to seek the advice of a Tennessee Clomid lawsuit attorney to learn more about their rights and remedies.
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