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Actiq and Pregnancy

When pregnant animals were given high doses of fentanyl, the active ingredient in Actiq, it caused several problems in the offspring, including reduced survival rates. Due to these potential risks, the United States Food and Drug Administration has classified Actiq as a pregnancy Category C medication. However, this medication may be prescribed to a pregnant woman if the benefits outweigh the risks.

Can Pregnant Women Use Actiq?

Actiq® (fentanyl lozenge) is a prescription narcotic pain medication approved to treat breakthrough cancer pain (sudden bursts of pain that "break through" regular pain medication). 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.
In animal studies, giving intravenous (IV) doses of fentanyl (the drug's active ingredient) to pregnant animals caused decreased body weights in the offspring. When high IV 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.
Fentanyl is known to pass through the placenta to the developing fetus. The chronic use of fentanyl during pregnancy can cause the baby to become dependent on the drug. When the baby is no longer getting the medication (from 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 Actiq, 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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