Clomiphene, also known as clomifene and prescribed by their brand names Clomid and Serophene, is an ovulation-inducing medication used to infertility in women who are unable to produce eggs. However, Pennsylvania Clomid lawsuit attorneys note a possible association between the drug and certain birth defects, especially those affecting the head, heart, and digestive system.
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What is Clomiphene?
Clomiphene is a non-steroidal fertility medication, commonly used to stimulate and trigger ovulation. Despite the effectiveness of the medication to treat infertility, there have been a number 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?
One of the most common medications used to treat infertility, Clomiphene works by blocking estrogen receptors at the hypothalamus, a part of the brain responsible for hormone production. The hypothalamus stimulates the pituitary gland to secrete follicle stimulating hormone (FSH) and luteinizing hormone (LH). In some cases, Clomiphene may also be prescribed to treat male infertility as well as menstrual abnormalities, fibrocystic breasts, and continuous breast milk production. The U.S. Food and Drug Administration (FDA) has neither tested nor approved any “off-label” use of the drug.
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 septal heart defects and muscular ventricular septal defect.
According to the CDC report, children of mothers who said they used clomiphene more often than mothers of children who did not use the fertility medication experienced serious birth defects including:
- Anencephaly (unusual brain and skull development)
- Septal heart defects (abnormal connection between the heart’s lower chambers)
- Coarctation of the aorta (narrowing of the large, oxygen carrying blood vessel from the heart to the body)
- Esophageal atresia (underdeveloped esophagus)
- Craniosynostosis (premature closure of the skull)
- Omphalocele (intestine or abdominal organs are located outside of the body)
The CDC also reported that clomiphene was also correlated (in a very small number of cases) with the following birth defects:
- Dandy-Walker malformation (malformation of the brain and cerebellum and the fluid-filled spaces around it)
- Muscular ventricular septal defect (heart defect in which there is a hole in the ventricular septum, separating the two lower ventricles of the heart
- Cloacal exstrophy (a rare congenital malformation of the large intestine, bladder, and genitalia)
Fertility Drugs and Autism Spectrum Disorder
Autism Spectrum Disorder (ASD) may refer to a wide range of symptoms, skills and levels of impairment or disability that are present in conditions known as pervasive developmental disorders (PDD). Types of ASD include Asperger’s syndrome; pervasive developmental disorder, not otherwise specified (PDD-NOS); and autistic disorder. Autism Spectrum Disorder is often characterized by persistent deficits in social communication and interaction across a number of different contexts; restricted, repetitive patterns of behavior, interests, or activities; and are usually recognized within the first two years of the baby’s life.
In 2010, a study conducted by a team of researchers from the Harvard School of Public Health reported an association between ovulation inducing drugs and autism spectrum disorders (ASD) and concluded the use of such drugs should be considered as a potential risk factor for ASD in future studies. According to an article in Time reporting on the study, the association between fertility drugs such as Clomid and autism also appeared to strengthen 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 Pennsylvania 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 Pennsylvania Clomid lawsuit attorney to learn more about their rights and remedies.
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