A new study from the Centers for Disease Control (CDC) found that Clomid, a fertility drug, significantly increases the risk of several types of birth defects. Clomid (clomiphene citrate) is one of the most popular fertility drugs on the market and is also marketed as Serophene. Clomid works like estrogen, inducing ovulation in women who do not produce eggs.
The new research, which was published in the online journal Human Reproduction, studied women who used Clomid anywhere from two months before conception to the first month of pregnancy. Serious birth defects were observed, including anencephaly (open cranium lacking a brain), esophageal atresia (closed esophagus), omphalocele (abdominal wall defect), craniosynostosis (premature fusion of skull bones), and gastrointestinal and genital defects.
Earlier studies have also shown a link between the use of Clomid and birth defects. According to a 2010 study from the Harvard School of Public Health, ovulation-inducing drugs like Clomid nearly doubled the risk of autism spectrum disorder in children. Other studies pointed to an increased risk of defects such as craniosynostosis and spina bifida.
Clomid is classified by the FDA as pregnancy category X, showing the highest risk of birth defects when taken during pregnancy. This means that women should not take Clomid if they are pregnant.
General information on birth defects
Certain drugs contain substances called teratogens, which can cause birth defects. Teratogenic drugs can cause birth defects in three ways. Some cause damage to the fetus directly; others compromise the functioning of the placenta, which leads to low birth weight and underdevelopment. Lastly, some medications can induce premature labor, or violent contractions which can injure the fetus.
A fetus is most vulnerable when exposed to harmful drugs during the first trimester of the pregnancy. However, some drugs can harm the fetus when taken at any time during the pregnancy. Drugs taken 20 days or more before conception often have either no effect or induce miscarriage.
The FDA uses five pregnancy categories to classify drugs according to the risk of harm to a fetus:
- Category A - Sufficient and well-controlled studies show no evidence of risk to the fetus.
- Category B - Animal studies show no evidence of risk to the fetus; no sufficient and well-controlled studies on pregnant women.
- Category C - Studies on animals indicate a possible adverse effect on the fetus, but the drug's potential benefits may outweigh the risk. Sufficient and well-controlled studies in humans do not yet exist.
- Category D - Positive evidence of risk to human fetuses. However, the use of this drug by pregnant women may be warranted in some cases.
- Category X - Positive evidence of human fetal risk; women who are or could become pregnant should not take this drug (Clomid falls under this category)
- Category N - The FDA has not yet classified this drug.
If your child was born with birth defects that may have been caused by Clomid, please give us a call today. You may be entitled to compensation for past and future medical expenses, pain and suffering and more. Over the past 35 years, the birth defect attorneys of Oshman & Mirisola, LLP has built a reputation for high quality, aggressive representation. Contact us by calling (800) 400-8182 or submit our online Contact Us form for a free, no-obligation consultation.