Clomiphene citrate, the active ingredient in fertility drugs Clomid and Serophene, is used to treat infertility in women who are unable to produce eggs and become pregnant. Kansas Clomid lawsuit attorneys note a correlation between Clomiphene and birth defects that may affect the children of mothers who have used the medication.
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What is Clomiphene?
Clomiphene is a non-steroidal fertility treatment used to induce and stimulate ovulation. Although Clomiphene has been effectively used to induce ovulation since 1967, a number of side effects and risks have been associated with the medication. 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?
Clomiphene is a commonly prescribed fertility medication used to induce ovulation in women who are unable to produce eggs but wish to become pregnant. Clomiphene treatment works in a similar way as estrogen, a female hormone that aids in the production of eggs in the ovaries. Clomiphene is sometimes prescribed as a treatment for male infertility, however the drug is considered “off-label” and has not been tested or 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 esophageal atresia. According to the CDC report, mothers of children with the following birth defects said they used clomiphene in greater numbers 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 type of hernia in which the baby’s abdominal muscles do not grow properly
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 birth defect in which parts of the cerebellum develop abnormally, resulting in malformations of the baby’s brain
- Muscular ventricular septal defect: a congenital heart defect in which there is a hole in the septum separating the two lower ventricles of the heart
- Cloacal exstrophy: a serious birth defect in which much of the abdominal organs are exposed
Fertility Drugs and Autism Spectrum Disorder
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). Researchers determined that the use of fertility drugs should be regarded as a possible risk factor for ASD in subsequent studies. According to an article in Time reporting on the study, the association between ovulation-inducing drugs such as Clomid and autism appeared to intensify 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
- Harelip
- Multiple pregnancy
- Down syndrome
- Spina bifida
How a Kansas 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 Kansas Clomid lawsuit attorney to learn more about their rights and remedies.
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