Clomiphene, also known as clomifene and prescribed by its brand names Clomid and Serophene, is an ovulation-inducing medication used to infertility in women who are unable to produce eggs. However, Louisiana Clomid lawsuit attorneys note an association between the drug and certain birth defects, especially those affecting the head, heart, and digestive system.
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What is Clomiphene?
Originally used to treat anovulation, Clomiphene is an oral fertility treatment used to induce ovulation in women who cannot develop and release eggs. Although Clomiphene treatment has yielded high success rates, there is a correlation between certain side effects and risks and use of the medication. Side effects and risks of the drug 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
A study reported on by the Centers for Disease Control and Prevention (CDC), using data from the National Birth Defects Prevention Study (NBDPS), signals an association between clomiphene use and serious birth defects, including defects affecting brain, heart, and digestive system development. 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:
- Anencephaly: an underdeveloped brain and malformation of the skull
- Septal heart defects: a congenital heart defect in which an abnormal connection between the heart’s lower chambers develops, resulting in a hole in the heart
- Coarctation of the aorta: a narrowing the large blood vessel that leads from the heart and carries oxygen-rich blood to the body
- Esophageal atresia: a rare birth defect in which the baby is born without part of the esophagus, the tube that connects the mouth to the stomach
- Craniosynostosis: premature closing of one or more of the joints between the bones of a baby’s skull
- Omphalocele: a birth defect of the abdominal wall in which an infant’s intestines, liver, or other organs form outside of the body through the belly button
In some cases, as reported by the CDC, clomiphene was also correlated with the following birth defects:
- Dandy-Walker malformation: a congenital brain malformation of the cerebellum and the fluid-filled spaces around it
- Muscular ventricular septal defect: a congenital heart defect in which there is a hole in the wall (ventricular septum) that separates the two lower chambers (ventricles) of the heart
- Cloacal exstrophy: a rare congenital malformation of the large intestine, bladder, and genitalia
Fertility Drugs and Autism
In a presentation to attendees at the International Meeting for Autism Research in Philadelphia, a team of researchers from the Harvard School of Public Health revealed that women who used ovulation-inducing drugs had nearly double the risk of having a child with autism spectrum disorder (ASD). In an article published in Time magazine, the association between fertility drugs such as Clomid and ASD appeared to escalate with exposure.
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 Louisiana 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 Louisiana Clomid lawsuit attorney to learn more about their rights and remedies.
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