What is Serophene?
Serophene belongs to a class of drugs called ovulatory agents which are used as fertility medications by women who are having trouble getting pregnant. Serophene works by increasing certain hormones, which causes ovulation to occur. Clomiphene citrate, the active ingredient in both Serophene and Clomid, was first approved by the U.S. Food & Drug Administration (FDA) in February 1967.
What’s the Problem?
Despite its considerable effectiveness as a fertility drug, Serophene has long been associated with birth defects in both pre-approval clinical trials as well as postmarket surveillance. While the incidence rate of Serophene-related congenital abnormalities is relatively low, some have suggested that the drug’s labeling fails to adequately warn consumers of the risk of birth defects.
Clinical Trial Results
The following birth defects were linked to clomiphene citrate use during or before pregnancy at a rate of less than 1% in clinical trials for Clomid (listed in order of decreasing frequency):
congenital heart lesions; Down syndrome; clubfoot; congenital gut lesions; hypospadias; microcephaly; harelip / cleft palate; congenital hip; hemangioma; undescended testicles; polydactyly; conjoined twins / 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.
In addition to the defects identified in clinical trials, the following congenital malformations were associated with clomiphene citrate use during post-marketing surveillance:
delayed development; abnormal bone development including skeletal malformations of the skull, face, nasal passages, jaw, hand, limb (ectromelia including amelia, hemimelia, and phocomelia), foot and joints; tissue malformations including imperforate anus, tracheoesophageal fistula, diaphragmatic hernia, renal agenesis and dysgenesis, and malformations of the eye and lens (cataract), ear, lung, heart (ventricular septal defect and tetralogy of Fallot), and genitalia; as well as dwarfism, deafness, mental retardation, chromosomal disorders and neural tube defects (including anencephaly).
Serophene Birth Defects Studies
A 2010 study published in the journal Human Reproduction examined the link between birth defects and the use of clomiphene citrate by women who wanted to get pregnant. The researchers found that mothers whose children were born with the following defects were more likely to have used the drug than mothers of children who did not have the defects:
- septal heart defects
- coarctation of the aorta
- esophageal atresia
- Dandy-Walker malformation
- muscular ventricular septal defect
- cloacal extrophy
According to a warning from the Centers for Disease Control and Prevention (CDC), results of the study should be interpreted with caution because the findings are based on a small group of test subjects. However, if anything, the research indicates that further studies are needed to understand the link between Serophene and birth defects.
Do I Have a Serophene Class Action Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Serophene Lawsuits. We are handling individual litigation nationwide and currently accepting new birth defect cases in all 50 states.
Free Serophene Lawsuit Evaluation: Again, if your child has suffered from a birth defect after the mother took Serophene in pregnancy, you should contact our law firm immediately. You may be entitled to compensation by filing a class action suit and our lawyers can help.