Clomid is a fertility drug that is considered the first-line treatment for women trying to conceive. But without careful monitoring by a physician, Clomid treatment may result in any number of debilitating birth defects.

Clomid is manufactured by Sanofi Aventis under the brand name clomifene or clomiphene citrate. It’s used to stimulate ovulation in women who are having trouble getting pregnant due to certain medical conditions that inhibit ovulation. It’s typically administered over a five-day treatment cycle that usually results in ovulation within five to ten days. If Clomid use does not result in pregnancy after three treatment cycles, it’s recommended that the patient stop Clomid treatment and be reevaluated other treatment options.

While Clomid has value prior to pregnancy, problems may arise if it remains in the mother’s body after pregnancy is initiated. In fact, even though Clomid is useful for initiating pregnancy, the FDA puts Clomid in pregnancy category X, meaning there is no benefit to taking Clomid during pregnancy that outweighs the risks. For this reason, it’s crucial that Clomid treatment be closely monitored. The patient’s physician must watch for onset of pregnancy, possible ovarian enlargement, or appearance of ovarian cysts.

National Birth Defects Prevention Study

The Centers for Disease Control and Prevention (CDC) conducted a study called the National Birth Defects Prevention Study to examine the relationship between Clomid use and birth defects. Researchers interviewed mothers who had given birth between October 1997 and December 2005, some of whom had given birth to children with birth defects and others whose children were born healthy. Some of the mothers in the study had taken clomiphene citrate, the active ingredient in Clomid, between two months prior to pregnancy and one month into pregnancy. The researchers found several possible associations between clomiphene citrate and birth defects. But the researchers also noted that these results should be interpreted cautiously due to the small number of cases observed and the inconsistency with results of prior studies.

Another study, published online in the New England Journal of Medicine, studied the outcomes of thousands of births in Australia. They found the largest increase in risk was associated with Clomid. In cases where the mother took Clomid without adequate medical supervision, it was associated with a 300 percent increase in the risk of birth defects.

While the available data on Clomid use in people is inadequate to establish a cause and effect relationship between Clomid and birth defects, studies done on animals showed increases in many undesirable outcomes, including physical malformations and fetal death. Some such studies resulted in cataracts, cleft palate, bone malformations, and physical alterations of the reproductive and digestive tracts.

The list of human birth defects that may be associated with Clomid is long and varied. Clomid birth defects may include heart defects, spina bifida, blindness, Down’s syndrome, and cleft lip or cleft palate. Some reports have also cited deafness and other ear abnormalities, deformed genitalia, alterations of the gastrointestinal tract, malformations of the lungs, and neural tube defects. Clomid may also increase the risk of prenatal death.

For the families dealing with Clomid birth defects, the consequences can be devastating. These conditions cause physical injury as well as considerable pain and suffering. Some of these conditions may require a lifetime of medical treatment, incurring continuous medical expenses while possibly reducing the patient’s earning potential.