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What Is Pregnancy Category C?
The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medicines that have not been adequately studied in pregnant humans but do appear to cause harm to the fetus in animal studies.
In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Fentanyl has not been studied in pregnant women. However, when fentanyl was given to pregnant animals, it caused miscarriages and reduced body weights in the offspring. In addition, when high doses of fentanyl were given to rats during pregnancy and while breastfeeding, it caused delayed tooth emergence, decreased motor activity, and reduced survival rates in the offspring.
This medicine passes through the placenta to the developing fetus. Thus, the chronic use of fentanyl during pregnancy may cause the baby to become dependent on the drug. Because the baby is no longer getting the medication via the mother after birth, narcotic withdrawal symptoms may occur. Symptoms of narcotic withdrawal in the newborn may include:
- Decreased respiration (decreased breathing)
- Changes in behavior, such as irritability, jitteriness, or restlessness
- Excessive or high-pitched crying
- Poor feeding
The use of intravenous or epidural fentanyl during labor has been associated with temporary muscle stiffness (muscle rigidity) in the newborn, but has not been associated with withdrawal symptoms in the newborn.
Pregnancy Category C medicines, including fentanyl, may be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child.