The attorneys at Taylor Martino, P.C. are currently investigating the link between the use of the medication Clomid (generic: clomiphene citrate) (Olmesartan medoxomil) and serious and even life-threatening birth defects in children born to mothers who took the drug before or during pregnancy.
If your child or someone you know has given birth to a child with birth defects after taking Clomid, our attorneys would like to hear from you. You may be able to sue the manufacturer to recover compensation for medical expenses, pain and suffering, and other losses. Please contact us today for more information on your potential legal rights.
Clomid B irth Defects: An Overview
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 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.
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.
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.
Some of the most serious birth defects associated with Clomid include anencephaly, craniosynostosis, and septal heart malformations.
Clomid B irth Defects
Medical literature has linked Clomid to the following birth defects:
- Anencephaly (absence of parts of the brain or skull)
- Dandy-Walker malformation (absence of the cerebellar vermis part of the brain)
- Septal heart defects (hole in the heart)
- Muscular ventricular septal defects (incomplete forming of the heart)
- Coarctation of aorta (narrowed aorta)
- Esophageal atresia (closed esophagus)
- Cloacal exstrophy (exposed abdominal organs)
- Craniosynostosis (premature closure of the baby’s head)
- Omphalocele (exposed organs)
- Congenital heart lesions (heart abnormalities)
- Down syndrome
- Club foot
- Congenital gut lesions (intestinal abnormalities)
- Hypospadia (abnormal development of the urethra)
- Microcephaly (abnormally small head)
- Harelip and cleft palate
- Congenital hip (dislocation or instability of the hip)
- Hemangioma (abnormal growth of blood vessels)
- Undescended testicles
- Polydactyly (additional fingers or toes)
- Conjoined twins
- Teratomatous malformation (tumor-like tissue)
- Patent ductus arteriosus (abnormal blood flow due to abnormal blood vessel)
- Amaurosis (vision loss)
- Arteriovenous fistula (abnormal connection between artery and vein)
- Inguinal hernia
- Umbilical hernia
- Syndactyly (fusion of fingers, toes or limbs)
- Pectus excavatum (abnormal growth of the ribs and sternum)
- Myopathy (muscle weakness)
- Dermoid cyst of scalp (tumor)
- Spina bifida occulta (malformed vertebrae in the spine)
- Ichthyosis (skin disorders)
- Persistent lingual frenulum (tissue that finds the tongue to the floor of the mouth)
- Neonatal death
- Fetal death/stillbirth
- Bone changes or abnormal development
- Delayed development
- Mental retardation
- Chromosomal disorders
- Renal agenesis (abnormal development of the kidneys)
- Dysgenesis (abnormal development of an organ)
For expectant mothers, it can also mean problems during pregnancy including:
- Dystocia (difficult or abnormal childbirth for the mother)
- Delayed parturition (delayed childbirth)
- Multiple births
Clomid Clinical Trials and Birth Defects in Humans
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, post marketing 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.
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%.
More recently, an article published in a November 2010 issue of Human Reproduction (http://m.humrep.oxfordjournals.org/content/early/2010/11/26/humrep.deq313 ) 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.
Animal Birth Defect Studies
Multiple studies have been conducted on mice and rats to determine the effects of Clomid on animals. When clomiphene citrate is given to pregnant rats, it results in a wide range of abnormalities that intensify with stronger doses of the drug. Clomid is associated with low implantation rates of the egg, low fetus weight, and high rates of fetal death. There were also high rates of exencephaly, a condition where the brain is outside the skull.
Other studies suggest that higher doses of Clomid given to pregnant rats resulted in dead fetuses and difficult or delayed childbirth for mothers. The highest dosages caused maternal mortality, fetal cataracts and fetal cleft palate.
Other Uses for Clomid
Doctors have also been known to prescribe Clomid to men for male infertility, especially low production of testosterone. Clomid therapy is an attractive option because it restores the body’s natural production of testosterone, while allowing men the ease of taking a pill, often at a decreased price, instead of receiving testosterone injections.
Women may also be prescribed the drug, even if not trying to become pregnant. They may be prescribed the drug for menstrual abnormalities, fibrocystic breasts, and prolonged breast milk production.
The FDA has not approved Clomid for these uses. Be sure to speak with your doctor if you are taking or thinking of taking Clomid for any of these off-label treatments.
Getting Legal Help
By filing a lawsuit against the manufacturer of Clomid, you may be entitled to collect compensation for all current and future medical expenses related to the treatment of your child’s birth defect, as well as damages for pain and suffering. In addition, filing a lawsuit can help hold the drug’s maker accountable for releasing an allegedly defective drug into the marketplace and to discourage other pharmaceutical companies from engaging in similar conduct.
If your child or someone you know has given birth to a child with birth defects after taking Clomid, please call us at (251) 433-3131 for a free confidential consultation.