Paul Tassin  |  April 27, 2015

Category: Legal News

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close-up portrait of a beautiful sleeping baby on whiteThe infertility drugs Clomid and Serophene may result in life-altering birth defects if not administered properly.

Both Clomid and Serophene are brand names for the generic drug clomiphene. Since the FDA first approved it in February 1967, it has earned a reputation for being particularly effective treatment for certain kinds of female infertility.

Clomid operates on the endocrine system in several ways that combine to trigger ovulation in women for whom normal ovulation has stopped. Today Clomid is often the first treatment attempted to remedy cases of female infertility.

Unfortunately, several studies have shown a possible association between Clomid or Serophene use and certain severe birth defects. A 2010 study by the Centers for Disease Control and Prevention found several associations between Clomid (studied under its chemical name clomiphene citrate) and birth defects.

A more recent study published in the New England Journal of Medicine in 2012 reviewed the results of various types of infertility treatments and found the largest increase in risk of birth defects was associated with Clomid.

Clomid’s efficacy as an infertility treatment is not seriously questioned. But once the mother becomes pregnant, continued presence of Clomid in her body creates a risk of exposure to the embryo. Thus proper administration of Clomid requires ongoing medical supervision. The 2012 study found that when used without medical supervision, Clomid was associated with a 300 percent greater risk of birth defects.

Much of what medical science knows about Clomid birth defects comes from animal studies. Researchers often qualify their conclusions by saying they can’t be certain whether the birth defects they found resulted from Clomid use or from the underlying infertility.

When Clomid birth defects occur, they can be devastating. Physical malformations can include club foot, cleft palates or cleft lip, supernumerary fingers or toes, hip dislocation or instability, malformations of the head, conjoined twins, fusion of limbs, and dwarfism.

Internal organs can also be malformed, resulting in congenital heart defects, malformations of the aorta, incomplete development of the esophagus, exposure of internal organs on the outside of the body, intestinal abnormalities, various types of congenital hernias, and premature fusion of the bone plates in the skull.

Clomid exposure may also result in disorders such as Down syndrome, mental retardation, spina bifida occulta, or Dandy-Walker malformation (when a part of the brain called the cerebellar vermis fails to develop).

Clomid can also result in fetal death or neonatal death. A 1991 study found that among pregnancies that followed Clomid treatment, almost one-in-five spontaneously aborted.

Because of the severity of these possible Clomid birth defects, the FDA places Clomid in pregnancy category X, meaning the risks of Clomid birth defects clearly outweigh the benefits of taking Clomid during pregnancy.

Sometimes physicians prescribe Clomid to treat conditions other than infertility, such as fibrocystic breast disease, prolonged milk production, or menstrual abnormalities. While physicians are not prohibited from prescribing a medicine for such “off-label” uses, those uses still present the same risk of birth defects should the patient become pregnant.

Families dealing with the effects of Clomid birth defects may have legal recourse for the harm done. Birth defect lawyers are available to discuss options for those families dealing with fertility drug side effects following treatment with Clomid or Serophene.

In general, Clomid lawsuits are filed individually by each plaintiff and are not class actions.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. Hurry — statutes of limitations may apply.

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If you or a loved one became pregnant after taking Clomid and had a baby with a birth defect, you may have a legal claim. See if you qualify to pursue compensation for your child’s medical expenses, pain and suffering, and other damages by filling out the form below.

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