A study has shown a correlation between Clomiphene, also known as clomifene and sold under the brand names Clomid and Serophene, and certain birth defects, including those affecting the head and the heart. Affected patients may be eligible for a Florida Clomid lawsuit due to the medication’s more harmful side effects and risks.
For more information, contact the Attorney Group for Florida 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 Clomid birth defect lawsuit attorney who can assist you throughout the legal process.
What is Clomiphene?
Clomiphene is a fertility medication used to treat ovulatory dysfunction and polycystic ovary syndrome and stimulate ovulation. Although Clomiphene has been used for more than 40 years to induce ovulation, a number of side effects and risks have been associated with the medication. Clomiphene risks and side effects include nausea, multiple pregnancies, birth defects, abnormal vaginal bleeding, breast discomfort, and hot flashes.
How Does Clomiphene Work?
Clomiphene is a commonly prescribed fertility medication used to stimulate ovulation in women who are unable to produce eggs but wish to become pregnant. It works similarly to estrogen, a female hormone that causes eggs to develop in the ovaries and be released. Clomiphene is also prescribed as an off-label medication to men to treat secondary hypogonadism (a condition where the body doesn’t produce enough testosterone). “Off-label” means that the drug has been neither tested nor approved by the U. S. Food and Drug Administration (FDA) for this purpose.
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, mothers of children with the following birth defects said they used clomiphene more often than mothers of children without birth defects:
- Anencephaly: abnormal development of the brain and the bones 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 congenital narrowing of the aorta, the largest blood vessel in the body that 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: one or more of the joints between the bones of a baby’s skull close prematurely
- 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
The CDC also reported that clomiphene was also correlated (in a very small number of cases) 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 extrophy: a rare congenital malformation of the large intestine, bladder, and genitalia
Fertility Drugs and Autism
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 Florida 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.
The parents of children who were born with birth defects linked to Clomid may be entitled to compensation for damages, including the child’s:
- Medical expenses
- Pain, suffering, and mental anguish
- Scarring or physical deformities caused by the birth defect or treatment
If a child died due to birth defects linked to Clomid, family members may be entitled to compensation for the wrongful death of their loved one, including:
- Conscious pain and suffering of their child prior to death
- Pain, suffering, and mental anguish from the loss of a child
- Funeral expenses
Affected families are encouraged to seek the advice of a Clomid birth defect lawsuit attorney to learn more about their rights and remedies.
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