WHAT IS CLOMID?
Clomid is a brand name, along with Serophene, for the generic fertility drug clomiphene, which is used by women who have difficulty with ovulation but wish to get pregnant. Sold by Sanofi-Avantis, Clomid was initially approved by the FDA in February of 1967. 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.
WHAT ARE CLOMID RISKS?
A study reported on by the Centers for Disease Control and Prevention (CDC) has noted a correlation between clomiphene use and serious birth defects, including septal heart defects and muscular ventricular septal defect. The study involved women who reported using Clomid in the two months before conception and during the first month of pregnancy and noted that its findings “should be interpreted with caution because they are based on small numbers of women who used clomiphene citrate.”
The FDA has placed Clomid in the pregnancy Category X, meaning that the drug is contraindicated for use during pregnancy. The agency warns that available data do not suggest an increased risk for congenital anomalies when Clomid is used as indicated. However, animal reproductive toxicology studies showed increased embryo-fetal loss and structural malformations in offspring. If Clomid is used during pregnancy, or if the patient becomes pregnant while taking Clomid, the patient should be appraised of the potential risks to the fetus
BIRTH DEFECTS CORRELATED TO CLOMIPHENE INCLUDE:
- Cleft palate
- Visual disorders
- Club foot
- Down syndrome
- Spina bifida
CLOMID POSSIBLY LINKED TO BIRTH DEFECTS.
An article published in the November 2010 issue of Human Reproduction explored any links between 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.
According to the FDA, the following fetal abnormalities have been reported subsequent to pregnancies following ovulation induction therapy with Clomid during clinical trials: Congenital heart lesions, Down syndrome, club foot, congenital gut lesions, hypospadias, microcephaly, cleft palate, congenital hip, hemangioma, undescended testicles, polydactyly, conjoined twins and teratomatous malformation, patent ductus arteriosus, amaurosis, arteriovenous fistula, inguinal hernia, umbilical hernia, syndactyly, pectus excavatum, myopathy, dermoid cyst of scalp, omphalocele, spina bifida occulta, ichthyosis, and persistent lingual frenulum. The FDA does note that the overall incidence of reported congenital anomalies from pregnancies associated with maternal Clomid ingestion during clinical studies was within the range of that reported for the general population.
THE TIME TO PURSUE A CLAIM IS LIMITED. CONTACT US TODAY
If you or somebody you know took a clomiphene product a had a baby with a birth defect, contact the Attorney Group today. We offer free, confidential, no obligation consultations. We can help answer your questions, and if you choose to pursue a claim we can connect you with an affiliated attorney who can assist you throughout the legal process.