How does the FDA Classify Teratogenic Drugs?

If a drug is classified as being teratogenic, it means that medication has the potential to cause developmental malformations or birth defects to a fetus when taken by a pregnant woman. It is part of the FDA’s job to study the effects medications may have on fetal development so that they can properly warn doctors and their patients about possible birth defect side effects, allowing them to decide whether different medications may be more appropriate for expecting mothers.

The FDA has created a system to classify teratogenic drugs according to the potential risk to a baby. The five categories used to represent the possible threat of teratogenic medications when taken by pregnant women are:

Category A

Multiple tests and studies have shown that drugs in this category show no evidence of risk to a baby when taken during the first trimester of pregnancy. This is the safest category of drugs in light of threats to fetal development.

Category B

Medications in Category B have been placed in this class for one of two reasons:

  • No human studies have been conducted, but studies conducted on animals show no risk to a fetus
  • Human studies show no risk to a fetus, but studies performed on animals may indicate a risk

Category C

Doctors are advised by the FDA to prescribe teratogenic drugs to pregnant women only when the benefits can be shown to outweigh the risks. The FDA may add a drug to the Category C class if:

  • No studies have been conducted on humans or animals
  • Or animal studies indicate a possible risk to a fetus but no human studies are available to confirm this

Category D

Though the benefits of these drugs to mothers may outweigh the risks, there is evidence that they may harm a fetus. These drugs may be prescribed to pregnant women if no other drugs are available or if they are necessary to treat a life-threatening illness.

Category X

These drugs have been shown in both human and animal studies to pose a serious risk to a fetus, or there is data from actual pregnancies that indicate this risk.

Doctors should not prescribe these drugs to women who are or who may become pregnant, as the substantial risks outweigh any proposed benefits.

A number of women and families with children whose birth defects may be attributed to medications taken during pregnancy have chosen to file personal injury lawsuits in pursuit of compensation for medical bills and other damages. If you believe your child’s birth defect or developmental delay may be linked to a medication taken while the child was developing in the womb, contact the Law Offices of Melinda J. Helbock, A.P.C. to schedule a legal consultation where you can learn more about your rights.