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Abstral and Pregnancy

When the active ingredient in Abstral (fentanyl sublingual tablets) was given to pregnant animals, it caused several problems in the offspring, including delayed tooth emergence, decreased motor activity, and death. If you happen to be taking Abstral and you become pregnant, your healthcare provider will weigh the risks and benefits before making a recommendation.

Can Pregnant Women Take Abstral?

Abstral® (fentanyl sublingual tablets) is a prescription narcotic pain medication approved to treat breakthrough cancer pain (sudden, intense flares of pain that occur despite around-the-clock pain medication treatment). Abstral 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.
Abstral has not been studied in pregnant women. In animal studies, fentanyl (the active ingredient in Abstral) did not cause birth defects when given to pregnant animals, but did cause miscarriage and reduced body weight in the offspring. High doses of fentanyl given to rats during pregnancy and while breastfeeding caused delayed tooth emergence, decreased motor activity, and reduced survival rates in the offspring.
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.
However, pregnancy Category C medicines, including Abstral, 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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