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Duragesic and Pregnancy

If you are expecting, Duragesic (fentanyl patch) may not be the best choice for you, as the full risks are unknown. When high doses of the active ingredient in this medication were given to pregnant animals, several problems occurred in the offspring, including low body weight and decreased motor activity. If you are using Duragesic and pregnancy occurs, discuss the potential risks with your doctor.

Can Pregnant Women Use Duragesic?

Duragesic® (fentanyl patch) is a prescription narcotic pain medication approved to treat moderate-to-severe chronic, persistent pain. This medication may not be safe for use during pregnancy, although the full risks are unknown.

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.
Duragesic has not been adequately studied in pregnant women. When given intravenously to pregnant animals, fentanyl (the active ingredient of Duragesic) caused decreased body weight in the offspring. When high doses were administered intravenously to rats during pregnancy and while breastfeeding, several problems occurred in the offspring, including delayed eye opening and tooth emergence, decreased motor activity, and death.
Fentanyl passes through the placenta to the developing fetus. 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. The 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
  • Seizures.
The use of intravenous or epidural fentanyl during labor has been associated with temporary newborn muscle stiffness (muscle rigidity), but has not been associated with newborn withdrawal symptoms. However, Duragesic is a long-acting fentanyl product approved for the treatment of chronic pain. It is not an appropriate choice for the treatment of pain associated with labor and delivery.
However, pregnancy Category C medicines, including Duragesic, 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.
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