Clomiphene, a commonly prescribed fertility drug sold under the brand names Clomid and Serophene, is often given to induce ovulation in women that do not ovulate on their own. Illinois Clomid lawsuit attorneys note a correlation between the use of Clomiphene and certain congenital birth defects that may affect the children of mothers who used Clomiphene.
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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 works by acting on the estrogen receptors in the hypothalamus, a portion of the brain responsible for hormone production. Follicle stimulating hormone (FSH) and luteinizing hormone (LH) are then released by the hypothalamus to stimulate the production of eggs. In addition to infertility treatment in women, clomiphene can be used to treat male infertility, however, this type of treatment has not been tested nor approved by the FDA and is considered “off-label.”
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 severe 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 experienced the following complications in greater numbers than children of mothers who did not use the drug:
- Previous birth defects associated with Clomiphene include neutral tube defects (NTDs), hypospadias, and craniosynostosis
- Significant associations between Clomiphene and anencephaly (unusual brain and skull development), Dandy-Walker malformation (brain malformation), 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 exstrophy (unusual position of the large intestine)
These and other birth defects may require one or more surgeries to treat the defect, often resulting in large medical costs to the child’s parents and family. In the case of some defects, such as those affecting the heart, the child may require multiple medical procedures as they age in addition to initial surgical procedures within the first three years of their life.
Fertility Drugs and Autism
In June 2010, a group of researchers from the Harvard School of Public Health reported to attendees at the International Meeting for Autism Research in Philadelphia that women who used fertility treatment to induce ovulation had nearly twice the risk of having a child with autism spectrum disorders (ASD) verses women who did not use any fertility treatment. As reported by Time magazine, the association between ovulation-inducing drugs such as Clomid and autism also appeared to strengthen with exposure. The study indicated that the chances of children having ASD increased as women reported being treated for infertility using ovulation treatment.
Other Clomid Side Effects
The following side effects have also been reportedly associated with ovulation induction therapies such as Clomid by the FDA:
- Cleft palate
- Visual disorders
- Club foot
- Harelip
- Multiple pregnancy
- Down syndrome
- Spina bifida
How an Illinois 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 an Illinois Clomid lawsuit attorney to learn more about their rights and remedies.
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