Clomid (also known as Serophene) is the brand name for Clomiphene, a popular ovulation-inducing medication used to treat infertility in women who are unable to become pregnant. However, Texas Clomid lawsuit attorneys note a potential association between the drug and certain birth defects, especially those affecting the brain, heart, and digestive system.
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What is Clomiphene?
Clomiphene is a popularly prescribed medication used to help women produce eggs and ovulate more regularly. Despite the drug’s ability to increase ovulation in women who are unable to produce eggs, there are a number of side effects and risks related to the use of Clomiphene. Examples of Clomiphene risks and side effects include mood swings, hot flashes, abdominal discomfort, visual disturbances, and nausea.
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 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 as well as menstrual abnormalities, fibrocystic breasts, and continuous breast milk production. “Off-label” use of clomiphene has not been tested or approved by the U. S. Food and Drug Administration (FDA) to treat any conditions other than female 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), notes a correlation between clomiphene use and serious birth defects, including esophageal atresia and cloacal extrophy.
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: a condition that refers to the incomplete development of the brain, skull, and scalp
- 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: narrowing of the aorta, resulting in the restriction of blood flow to the body
- Esophageal atresia: a rare birth defect in which the esophagus does not develop normally and is separated into two parts
- Craniosynostosis: a condition that causes an infant’s head to be oddly shaped
- Omphalocele: a birth defect in which the intestines or abdominal organs are located outside of the body due to a hole in the navel area
In a small number of cases, the CDC also indicated that clomiphene was associated 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
Researchers from the Harvard School of Public Health reported an association between ovulation inducing drugs and autism spectrum disorders (ASD). The 2010 study concluded that the use of such drugs should be considered as a potential risk factor for ASD in future studies. Additionally, Time magazine reported on the same study, and stated that the association between fertility drugs such as Clomid and autism appeared to grow 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 Texas 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 Texas Clomid lawsuit attorney to learn more about their rights and remedies.
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