Fentora and Pregnancy
In pregnancy studies on the active ingredient in Fentora (fentanyl buccal tablets), several problems were reported in the offspring, including delayed tooth emergence, decreased motor activity, and death. If you become pregnant while taking this drug, your healthcare provider will weigh the benefits and potential risks before making a recommendation.
Can Pregnant Women Use Fentora?Fentora® (fentanyl buccal tablets) is a prescription narcotic pain medication approved to treat breakthrough cancer pain (sudden flares of pain that "break through" around-the-clock pain medication) in people with cancer. 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.
Fentora has not been studied in pregnant women. Fentanyl, the active ingredient of Fentora, has been shown to cause problems when given to pregnant animals, including miscarriages and a decreased body weight in the offspring. When high doses of fentanyl were given to rats during pregnancy and while breastfeeding, several problems occurred in the offspring, including delayed 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
However, pregnancy Category C medicines, including Fentora, 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.