Side effects of Clomid and other fertility treatments have been associated with an increased risk of birth defects, according to the findings of a recent study.

Australian researchers focusing primarily on in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) types of assisted contraception and the rate of birth defects linked to those techniques, found that birth defects linked to the use of Clomid surpassed any linked to any other drug. The researchers also found that babies born to couples who struggled for more than one year in getting pregnant were 40 percent more likely to have a birth defect.

The researchers found that 8.3 percent risk of birth defects in pregnancies that involved fertility treatments, versus 5.8 percent risk of birth defects when the pregnancy did not involve a fertility treatment. Overall, using an assistive reproductive technology increased the risk of having a baby with a birth defect by 28 percent. However, women who use Clomid for infertility may have an even higher risk.

The researchers found that women who used Clomid without medical supervision tripled their risk of having a baby born with a birth defect. The U.S. Food and Drug Administration (FDA) has already added information on the label of Clomid to warn women not to use Clomid during pregnancy, because it increases the risk of major birth defects.

The study was published in the New England Journal of Medicine and is the largest-ever study of birth defects and fertility treatments. The researchers analyzed 16 years of data (1986–2002) from clinics in South Australia involving 300,000 babies, of which 18,000 had a birth defect.

The types of birth defects were described as “cardiovascular, muscoloskeletal, urogenital, gastrointestinal abnormalities and cerebral palsy.” The researchers warned that the increased risk of birth defects may be related to an unknown underlying problem, which also contributes to infertility.

Clomid Birth Defects: An Overview

Clomid, manufactured by Sanofi-Avantis, was initially approved by the FDA in February  1967. Clomid is a fertility drug that 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 five days.

However, while Clomid assists infertility in women, it may also cause birth defects in their babies. Evidence suggests that even after Clomid has successfully fertilized ovulation, it is possible that Clomid remains in the mother’s system well into the initial weeks of pregnancy, which can put the fetus at risk of exposure to a dangerous drug.

Clomid is classified as a Category X drug by the FDA, meaning it is known to cause birth defects. Animals or humans have developed fetal abnormalities in clinical research and there is evidence to suggest human fetuses may be at risk. As a Category X drug, the risks may outweigh the potential benefits. Some of the most common birth defects reported in Clomid clinical trials included:

• Congenital heart defects
• Down’s syndrome
• Club foot
• Cleft palates
• Umbilical hernia
• Spina bifida

Additionally, since the drug has been on the market, more reports of Clomid birth defects have occurred. The most serious of them include:

• Delayed development
• Abnormal bone and organ development
• Dwarfism
• Deafness
• Chromosomal disorders
• Neural tube defects
• Malformations of the eye, ear, lung, heart and genitalia
• Skeletal malformations of the skull, face, nasal passages, jaw, hand, foot and joints

Clomid Birth Defects Lawsuits

Because a number of women used Clomid during pregnancy but were not made aware of the risks for birth defects associated with Clomid, Clomid lawsuits are being filed.