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Clomid Lawsuits

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In 2010, the CDC warned about a study linking the fertility drug Clomid with higher rates of severe, life-threatening birth defects in babies born to women used it before or during pregnancy.

How Does Clomid Work?

Clomid, manufactured by Sanofi-Avantis, was initially approved by the FDA in February of 1967. Clomid is a fertility drug used by women who do not produce ova (eggs), but wish to get pregnant. Similar to the natural hormone estrogen, Clomid induces ovulation, causing a woman’s ovaries to release an egg. It belongs to a class of drugs known as ovulatory stimulants and is usually taken in cycles of 5 days. Clomiphene citrate is also sold under the brand name Serophene.

Clomid Birth Defects

While Clomid assists infertile women get pregnant, it may also cause birth defects in their babies. Evidence suggests that even after Clomid has successfully fertilized ovulation, it is possible that Clomid remains in the mother’s system well into the initial weeks of pregnancy, which can put the fetus at risk of exposure to a dangerous drug.

Birth defect linked to Clomid include:

  • Neural tube (spina bifida)
  • Heart defects
  • Skull defects
  • Gastrointestinal defects (omphalocele)
  • Hypospadia
  • Cleft lip/palate
  • Limb defects
  • And more

Pregnancy Category X

Clomid is classified as a Category X drug by the FDA, meaning it is known to cause birth defects. Animals or humans have developed fetal abnormalities in clinical research and there is evidence to suggest human fetuses may be at risk. As a Category X drug, the risks may outweigh the potential benefits.

Study Links Clomid and Birth Defects

More recently, an article published in a November 2010 issue of Human Reproduction revealed an association between clomiphene citrate therapy and the birth defects of anencephaly, Dandy-Walker malformation, septal heart defects, muscular ventricular septal defects, coarctation of aorta, esophageal atresia, cloacal, exstrophy, craniosynostosis, and omphalocele.

Birth Defects in Clinical Trials

During Clomid clinical trials, fetal abnormalities — including those listed above — were reported at a rate of less that 1 percent. While these clinical trials showed low rates of birth defects that stay within the normal range of the general population (people not taking Clomid), the severity of the birth defects makes them a serious issue.

The most common birth defects reported in Clomid clinical trials included congenital heart lesions, Down’s syndrome, hydatidiform mole, club foot, congenital gut lesions, hypospadias, microcephaly, harelip, cleft palate, congenital hip, hemangioma, undescended testicles, polydactyly, conjoined twins and teratomatous malformation, patent ductus arteriosus, syndactyly, pectus excavatum myopathy, dermoid cyst of the scalp, arteriovenous fistula, inguinal hernia, umbilical hernia, omphalocele, spina bifida occulta, ichthyosis, persistent lingual frenulum, and still births.

Additionally, since the drug has been on the market, postmarketing surveillance has unearthed more reports of birth defects. The most serious of them include delayed development, abnormal bone development, dwarfism, deafness, mental retardation, chromosomal disorders, neural tube defects (including anenecephaly), tissue malformations, imperforate anus (blocked opening to the anus), tracheoesophageal fistula (closed esophagus), diaphragmatic hernia, renal agenesis (abnormal development of the kidneys), dysgenesis (abnormal development of an organ), malformations of the eye, ear, lung, heart and genitalia, and skeletal malformations of the skull, face, nasal passages, jaw, hand, lim, foot and joints.

Other Fetal Risks

A 1991 review of scientific literature showed patients who became pregnant after Clomid therapy showed a spontaneous abortion rate of 16-22%, meaning almost 1 in 5 pregnancies were naturally lost. Another study suggests Clomid is associated with a stillbirth rate of 1.0%.

Multiple Pregnancies

Not only has Clomid been associated with birth defects, it has also been linked to multiple births. In mothers who use Clomid therapy, the chances of of conceiving twins is 10%. There is always potential complications and hazards associated with multiple pregnancy. This risk is only intensified with links between Clomid and birth defects.

 

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