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. North Carolina 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 synthetic fertility medication primarily used to treat infertility in women cannot produce eggs but wish to become pregnant. Despite the drug’s use for more than 40 years to induce ovulation and treat infertility, there have been a number of side effects and risks correlated with the medication. Examples of Clomiphene risks and side effects include ovarian enlargement, flushing, stomach discomfort, blurred vision, nausea, and vomiting.
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 by the hypothalamus to induce ovulation. In some cases, Clomiphene may also be prescribed as an off-label medication to treat an absence of testosterone production in men known as hypogonadism. “Off-label” use of clomiphene has been neither tested nor approved by the U. S. Food and Drug Administration (FDA) to treat male infertility.
Clomiphene Birth Defect Risks
Using data from the National Birth Defects Prevention Study (NBDPS), a study reported on by the Centers for Disease Control and Prevention (CDC) and published in the journal Human Reproduction indicated a correlation between a small number of women who used Clomiphene to treat infertility and serious congenital birth defects. Birth defects affecting those children include defects that affect the head, heart, and limbs of the child (Reefhuis, Honein, Schieve, Rasmussen, and NBDPS).
Findings of the study indicate that children of mothers who used Clomiphene encountered the following problems in greater numbers than children of mothers who did not use the fertility treatment:
- Prior birth defects associated with Clomiphene use include neutral tube defects (NTDs), hypospadias, and craniosynostosis
- Significant associations between Clomiphene and anencephaly (unusual brain and skull development), Dandy-Walker malformation (brain malformation of the cerebellum), septal heart defects (unusual connection between the lower ventricles of the heart), muscular ventricular heart defects (hole in the wall of the heart’s lower chambers), coarctation of the aorta (narrowing of the aorta), esophageal atresia (underdeveloped esophagus), and cloacal extrophy (unusual position of the large intestine)
These and other birth defects could potentially require one or more surgeries to correct the condition, often resulting in large medical costs to the child’s parents and family. In addition to initial surgical procedures, the child may need multiple medical procedures within the first three years of their life, especially in the case of those birth defects affecting the heart.
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), a set of conditions characterized by a shared set of symptoms including those that affect a child’s social skills, speech, and behavior. Researchers 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 North Carolina 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 North Carolina Clomid lawsuit attorney to learn more about their rights and remedies.
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