The fertility drug Clomid (clomiphene) has been linked to severe, potentially life-threatening birth defects in babies born to mothers who take the medication before or during pregnancy.

 

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What is Clomid?

Clomid (generic: clomiphene citrate) is a widely-prescribed selective estrogen receptor modulator, or SERM, used to stimulate ovulation in women who are infertile. Studies have indicated a pregnancy rate of 5.5% per cycle with Clomid treatment vs. 1.3% without. Clomid has been in use since the 1960’s, and is a common first step in infertility treatments.

Clomid Birth Defects

A study conducted by the Centers for Disease Control and Prevention (CDC) and published in the journal Human Reproduction identified a link between Clomid use before or during pregnancy and a number of severe birth defects. Specifically, the researchers looked at data from the National Birth Defects Prevention Study (NBDPS) on women who had taken the drug in the 2 months before conception and during the 1st month of pregnancy, and found an increased incidence of the following congenital malformations:

  • Anencephaly – Baby born without parts of the brain and skull.
  • Septal heart defects – Hole(s) in the walls that separate the chambers of the heart.
  • Coarctation of the aorta (also known as aortic coarctation) – Narrowing of the aorta, the main blood vessel carrying oxygenated blood from the left ventricle of the heart to the rest of the body.
  • Esophageal atresia (also known as oesophageal atresia) – Causes the esophagus to end in a blind-ended pouch rather than connecting normally to the stomach.
  • Craniosynostosis – Condition in which one or more of the joints between the bones of the baby’s skull close prematurely, before the brain is fully formed.
  • Omphalocele – Baby’s intestine or other abdominal organs are outside of the body because of a hole in the belly button (navel) area.
  • Dandy-Walker malformation – Congenital brain malformation involving the cerebellum (an area at the back of the brain that controls movement) and the fluid-filled spaces around it.
  • Muscular ventricular septal defect – Opening in the muscular portion of the lower section of the ventricular septum.
  • Cloacal exstrophy – Defect in which much of the abdominal organs (bladder and intestines) are exposed. It often causes the splitting of both male and female genitalia, and the anus is occasionally sealed.

Click here for more specific information about these birth defects from the CDC.

Birth Defect Studies

In addition to the research cited above, a number of other studies have found links between Clomid and birth defects. Most notably was a 2003 study conducted by a research team led by CDC epidemiologist Dr. Jennita Reefhuis. Borrowing data from the NBDPS, Reefhuis compared Clomid exposure to 36 specific birth defects with 6,500 live babies born without major anomalies, used as controls. No less than 22 of the remaining 27 birth defect categories likewise showed an increased risk, ranging as high as 10% after exposure to Clomid.

Petition for Label Change

In December 2007, the consumer watchdog group Public Citizen filed a petition with the FDA requesting, among other things, that manufacturers of Clomid include a birth defect warning on the drugs’ labeling. Unfortunately, the document lay unsigned for nearly 2 years until the FDA denied the request.

Off-Label Uses

In addition to its uses as a fertility drug, Clomid may also be prescribed “off-label” to women for menstrual abnormalities, fibrocystic breasts and prolonged breast milk production. The drug has also been prescribed to men for the treatment of male infertility, especially low production of testosterone (Low-T).

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