CDC Study-Clomid Side Effects May Be Linked To Birth Defects
A study of Clomid (clomiphene-citrate) conducted by the Centers for Disease Control and Prevention (CDC) links the drug, Clomid, to significantly increased risks for numerous, serious birth defects, including cleft lip and palate. The CDC study involved women who reported use of the ovulation medication, Clomid, in the two months before conception and during the first month of pregnancy. Birth defects associated with Clomid are serious, and some are life threatening. The terrible irony is that the very fertility treatment prescribed to help women conceive may lead to their babies being born with seriously crippling and, in some cases, life-threatening birth defects.
The birth defect attorneys at Parker Waichman LLP are investigating potential lawsuits on behalf of children and their parents in cases in which the expectant mother was prescribed the fertility drug, Clomid, and the baby was born with, or suffers from, any of the adverse reactions indicated in the complete list of birth defects below. If your child was born with any of these birth defects and you believe that your use of Clomid may be to blame, we urge you to contact the attorneys at Parker Waichman LLP, who are experienced in defective drug and birth injury litigation. Please contact us at 1-800-YOURLAWYER (1-800-968-7529) today.
Clomid received approval from the U.S. Food and Drug Administration (FDA) in 1967 to assist women suffering from infertility issues to conceive. Clomid is the most commonly prescribed fertility drug and is in a class of drugs called ovulatory stimulants. Clomid functions by inducing ovulation (egg production) in women who are unable to produce eggs. When used by women, Clomid works similarly to estrogen, a female hormone that causes eggs to develop in the ovaries and to be released. Clomid is available as a tablet that is usually taken once a day for five days, beginning on or about day five of the woman's menstrual cycle.
The FDA has deemed Clomid as a Category X risk, the highest level pregnancy risk assigned to a drug, meaning that evidence exists that Clomid treatment may cause birth defects when used during pregnancy and that Clomid should not be used during pregnancy.
The FDA indicates that, in order to avoid inadvertent Clomid administration during early pregnancy, appropriate tests should be utilized during each treatment cycle to determine whether ovulation occurs. The patient should be evaluated carefully to exclude pregnancy, ovarian enlargement, or ovarian cyst formation between each treatment cycle. The next course of Clomid therapy should be delayed until these conditions have been excluded.
Off-Label Clomid Uses
Clomid is also sometimes used to treat male infertility, and is typically prescribed to treat low testosterone production. Clomid restores the body's ability to naturally produce testosterone and is often prescribed due to its low cost when compared to testosterone injections. The FDA has not approved Clomid for this off-label use.
Clomid is also sometimes prescribed off-label to treat menstrual abnormalities, fibrocystic breasts, and persistent breast milk production. The FDA has not approved Clomid for these off-label uses.
Clomid Animal Birth Defect Studies
When medications are considered too dangerous to administer to humans in the testing environment, testing is conducted on animals. When evidence of adverse side effects are seen in the animal testing environment, it is generally assumed that, if a birth defect is present in animals exposed to a medication, the same defect will occur in humans who are similarly exposed.
Animal studies suggest that higher doses of Clomid given to pregnant rats resulted in dead fetuses, and difficult or delayed childbirth for the mothers. The highest dosages caused maternal mortality, fetal cataracts, and fetal cleft palate.
Animal testing has also revealed evidence of fetotoxicity (injury to the fetus) in babies whose mother's were exposed to Clomid prior to conception and during development. Post marketing surveillance has supported these results in human data. The FDA recommends women who are, or could be, pregnant should not take this drug.
A variety of animal studies have also revealed a broad array of abnormalities that intensify with stronger Clomid doses. Research also found that Clomid is also associated with low implantation rates and low fetal weight, as well as high rates of fetal death. High rates of exencephaly were also seen.
Clomid Birth Defects Research
During Clomid clinical trials, fetal abnormalities were reported that indicated low, but very severe rates of birth defects. A clinical study involves research using human volunteers. Post-market surveillance also reveals reports of birth defects.
Until now, research examining the association between the fertility drug, Clomid, and birth defects has been inconclusive; however, a November 2010, the journal Human Reproductionpublished a study from the CDC that revealed a significant association with nine types of birth defects following the use of Clomid. The study utilized data from the National Birth Defects Prevention Study, a population-based, multi-site case control study of major birth defects. Women from 10 U.S. regions with deliveries affected by at least one of 30 birth defects and mothers of live born infants without a major birth defect (controls) who delivered from October 1997 through December 2005 were interviewed. Clomid medication use was reported by 1.4 percent of women in the study. Thirty-six birth defect categories with at least three exposed cases were studied. The implicated abnormalities included anencephaly, esophageal atresia, omphalocele, craniosynostosis, septal heart defects, muscular ventricular septal defect, coarctation of aorta, Dandy Walker Malformation Syndrome, and cloacal exstrophy.Twenty-two of the remaining 27 birth defect categories likewise showed an increased risk, ranging from10 percent to 170 percentfollowing Clomid exposure, although the study authors indicated that the numbers were insufficient to reach the scientific standard for statistical significance.
A 1991 review of scientific literature revealed that women who became pregnant following Clomid treatment experienced a spontaneous abortion rate of 16-22 percent (one in five pregnancies). Other research suggests Clomid is tied to a 1 percent stillbirth rate.
Other studies have also pointed to an association between Clomid for infertility and birth defects. For example, one study of 2,339 Clomid-assisted pregnancies found 58 reported cases of Clomid birth defects and reproductive complications, including spontaneous abortion and stillbirth.
The findings of these studies and resulting statistics may be extremely devastating to the women and their families who had struggled to become pregnant, and have finally given birth only to find that the fertility drug they were given caused their baby to suffer from a severe or deadly birth defect.
If you took Clomid and your child suffers from one of the birth defects listed here, or any other congenital abnormality, the Clomid birth defect attorneys at Parker Waichman LLP want to hear from you. You may be eligible to file a Clomid birth defect lawsuiton your child's behalf. To find out how our Clomid birth defect lawyers may help you and your child receive the compensation you deserve, please contact us today for a free Clomid birth defect lawsuit consultation or call us at 1-800-LAW-FIRM (1-800-968-7529).
Clomid Birth Defect Injuries
Research has identified the following as serious birth (congential) defects:
- Abnormal bone development.**
- Amaurosis: Vision loss.
- Ankyloglossia/Persistent lingual frenulum: Also known as "Tounge Tie" in which an unusually short, thick lingual frenulum (a membrane) connects the underside of the tongue to the floor of the mouth.*
- Arteriovenous fistula: Abnormal connection between an artery and a vein.*
- Bone changes.
- Chromosomal disorders.**
- Cloacal exstrophy: Multiple abnormalities of the gastrointestinal and genitourinary tracts that typically involve exposed abdominal organs.
- Coarctation of the aorta: Narrowed aorta.
- Congenital gut lesions: Intestinal abnormalities.*
- Congenital heart lesions: Heart abnormalities.*
- Congenital hip: Dislocation or instability of the hip.*
- Congenital Talipes Equinovarus (CTEV): Club foot.*
- Conjoined twins: Identical twins joined in utero.
- Craniosynostosis: Premature fusion of the skull bones, leading to an abnormally shaped head.
- Cryptorchidism: Undescended testicles.*
- Dandy Walker Malformation Syndrome: Brain malformation involving the cerebellum and its fluid-filled space. There are presently three types of Dandy-Walker complexes, with Dandy Walker Malformation Syndrome described as the most severe and involves the absence of the cerebellar vermis portion of the brain.
- Deafness: Partial or profound hearing loss.**
- Delayed development.**
- Dermoid cyst of the scalp: Scalp tumor.
- Diaphragmatic hernia: Abnormal opening in the diaphragm. The opening allows part of certain organs—stomach, spleen, liver, and intestines—to enter the chest cavity near the lungs**
- Down's Syndrome (Trisomy 21): The baby is born with a full or partial extra copy of chromosome 21, which is typically associated with physical growth delays, characteristic facial features, and mild to moderate intellectual disability.*
- Dwarfism: A condition of short stature.**
- Dysgenesis: Abnormal organ development.**
- Esophageal atresia/tracheoesophageal fistula: Closed or underdeveloped esophagus.**
- Exencephaly: A lethal neural tube defect that involves a congenital fetal brain developmental anomaly.
- Hemangioma: Abnormal blood vessel growth.*
- Fetal death/stillbirth: Death of a baby prior to delivery. Stillbirth usually involves a pregnancy loss following 20 weeks of gestation.*
- Hydatidiform mole (molar pregnancy): A noncancerous tumor that develops in the uterus.*
- Hypospadias and Penoscrotal Hypospadias: The opening of the urethra appears on the underside of the penis, not on the end of the penis.*
- Ichthyosis: Skin disorders.*
- Imperforate anus: Blocked opening to the anus.**
- Inguinal hernia: Protrusion of abdominal cavity contents through the inguinal canal.*
- Intellectual disabilities.**
- Limb Reduction Deficit: A birth defect in which all or some of the limbs of a fetus do not completely form while the baby is in utero.
- Malformations of the eye, ear, lung, heart, and/or genitalia.**
- Microcephaly: Abnormally small head.*
- Muscular ventricular septal defects: Incomplete formation of the heart.
- Myopathy: Muscle weakness.*
- Neonatal death: Death during the first 28 days of life
- Neural tube defects, including anencephaly, an open cranium with the absence of a brain. This is a potentially fatal birth defect.**
- Omphalocele: Intestines or other abdominal organs protrude from the bellybutton (navel); the intestines are covered by a thin layer of tissue and are easily seen.*
- Orofacial Cleft: Cleft lip, cleft palate.*
- Patent ductus arteriosus: Abnormal blood flow due to abnormal blood vessel.
- Pectus excavatum: Abnormal growth of the ribs and sternum.*
- Polydactyly: Extra fingers or toes.*
- Renal agenesis: Abnormal kidney development.**
- Septal heart defects: Hole in the heart.
- Skeletal malformations.**
- Spina bifida occulta: Malformed spinal vertebrae.*
- Syndactyly: Finger, toe, or limb fusion.*
- Teratomatous malformation: Tumor-like tissue.*
- Tissue malformations.**
- Umbilical hernia: A portion of the intestine protrudes through the umbilical opening in the abdominal muscles.*
- Other: Bone changes, intellectual disabilities.
*The most common birth defects reported in Clomid clinical trials.
** The most common birth defects reported in post-market surveillance.
Clomid Injuries to Expectant Mothers
- Dystocia: Difficult or abnormal childbirth.
- Delayed parturition: Delayed childbirth.
- Multiple births: Clomid has been associated with a 10 percent likelihood of conceiving twins. Multiple pregnancies are associated with possible complications and risks.
| Clomid Birth Defects Victim - Legal Help
If you believe Clomid may have caused your child to be born with a birth defect, you may have valuable legal rights. Our Clomid birth defect lawyers are currently offering free case evaluations to victims of Clomid injuries. To discuss filing a possible Clomid birth defect lawsuit with one of our attorneys, please fill out our online form, or call 1-800-YOURLAWYER (1-800-968-7529) today.