A correlation has been noted between Clomiphene, a drug commonly prescribed to treat infertility in women and known by its brand names Clomid and Serophene, and certain birth defects. Parents and families of affected children may be eligible to file a New York Clomid lawsuit and seek compensation for their injuries.
For more information, contact Attorney Group for New York 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?
Since the medication’s approval by the U. S. Food and Drug Administration (FDA) over 40 years ago, Clomiphene has been used to cause ovulation in women who are unable to become pregnant or with certain medical conditions such as polycystic ovary syndrome. Although the medication has been used as an effective treatment to induce ovulation, Clomiphene poses a number of risks, including enlargement of the ovaries, multiple pregnancies, abdominal pain or discomfort, blurred vision, nausea, and dizziness.
How Does Clomiphene Work?
Clomiphene, also known as clomifene, is an oral fertility medication used to trigger ovulation in women who are unable to produce eggs but desire pregnancy. It works similarly to estrogen, a female hormone that causes eggs to develop in the ovaries and be released. Clomiphene can also be prescribed as an off-label medication to treat a lack of testosterone production in men known as hypogonadism. “Off-label” treatments of clomiphene have not been tested or approved by the 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), reveals a correlation between clomiphene use and severe birth defects, including narrowing of the aorta and unusual development of the brain and skull. 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 (abnormal brain and skull development)
- Septal heart defects (abnormal connection between the heart’s lower chambers)
- Coarctation of the aorta (narrowing of the aorta)
- 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 (congenital brain malformation of the cerebellum and the fluid-filled spaces around it)
- Muscular ventricular septal defect (hole in the wall of the heart’s lower chambers)
- Cloacal exstrophy (abnormal position of the large intestine and bladder)
Fertility Drugs and Autism
Autism Spectrum Disorder (ASD) can 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). 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 New York 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 New York Clomid lawsuit attorney to learn more about their rights and remedies.
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