The fertility drug Serophene has been linked to severe, potentially life-threatening birth defects in babies born to mothers who take the medication before or during pregnancy.
Free Confidential Case Evaluation: If you or a loved one took Serophene during pregnancy and had a child with birth defects, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
What is Serophene?
Serophene (generic: clomiphene citrate) is one of the most commonly prescribed fertility drugs in America. It is classified as a selective estrogen receptor modulator (SERM), and is approved to induce ovulation in women who have difficulty producing their own eggs, but who still want to have children. Serophene may also be prescribed “off-label” to men for the treatment of male infertility or erectile dysfunction (ED).
Serophene Birth Defects
Unfortunately, use of Serophene before and during pregnancy has been linked to severe birth defects in both clinical trials and post-marketing surveillance.
In November 2010, a study conducted by the Centers for Disease Control and Prevention (CDC) was published in the journal Human Reproduction. Researchers determined that Serophene was linked to an increased risk for the following birth defects:
- Anencephaly – Absence of a major portion of the brain, skull, and scalp.
- Septal heart defects (also known as a “hole in the heart”) – Occurs when there is an opening in the walls that separate the chambers of the heart.
- Coarctation of the aorta (aka aortic coarctation) – Artery that carries blood away from the heart to the body is narrowed at some point.
- Esophageal atresia (aka oesophageal atresia) – Disorder of the digestive system in which the esophagus does not form properly in the womb.
- Craniosynostosis (aka synostosis) – Premature fusion of 2 or more bones of the skull.
- Omphalocele – Abdominal wall defect.
- Dandy-Walker malformation – Brain defect that occurs in the development of the cerebellum and 4th ventricle.
- Muscular ventricular septal defect – Opening in the muscular portion of the lower section of the ventricular septum.
- Cloacal exstrophy – Baby born with abdominal organs (bladder and intestines) exposed.
Pregnancy Category X
Because Serophene has been linked to an increased risk for birth defects, the drug has been placed in Pregnancy Category X by the FDA, meaning that studies have found it can cause congenital abnormalities. These problems are most likely to occur if a woman is unaware that she is pregnant and still taking Serophene. Click here to learn more about how the FDA categorizes prescription medications for use by pregnant women.
Serophene Side Effects
In addition to potentially causing birth defects in babies exposed to the drug in the womb, Serophene has been linked to the following side effects in users:
- Hot flashes
- Visual spots or flashes
- Nausea and vomiting
- Abnormal uterine bleeding
- Abdominal or pelvic pain
- Weight gain
- Breast discomfort
Is Serophene the Same as Clomid?
Serophene and Clomid are both trade names for clomiphene citrate. The drug was first synthesized in 1956 and approved for clinical use by the U.S. Food & Drug Administration (FDA) in 1967. All formulations are believed to work by the same mechanisms.
Do I Have a Serophene Lawsuit?
The Product Liability & Defective Drug 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 Confidential Lawsuit Evaluation: Again, if your baby was injured by Serophene side effects, you should contact our law firm immediately. You may be entitled to compensation by filing a Serophene Suit and our lawyers can help.