Pain Home > Subsys and Pregnancy

During animal studies, the active ingredient in Subsys (fentanyl sublingual spray) appeared to increase the risk for miscarriage, but did not cause any birth defects. This drug can be given to a pregnant woman if the benefits outweigh the risks. However, it should be noted that withdrawal symptoms, such as decreased breathing, could occur in a newborn whose mother took Subsys during pregnancy.

Can Pregnant Women Use Subsys?

Subsys® (fentanyl sublingual spray) 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). This medication may not be safe for use during pregnancy, although the full risks are currently 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. Subsys is classified as a pregnancy Category C medication.
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.
Subsys has not been studied in pregnant women. In animal studies, fentanyl, the active ingredient of Subsys, did not cause birth defects when given to pregnant animals; however, it did cause miscarriages at some dosages.
Fentanyl is known to pass through the placenta to the developing fetus. Chronic use of fentanyl during pregnancy has been associated with the development of opioid withdrawal symptoms in newborn infants. Symptoms of opioid withdrawal in a 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 Subsys, may be given to a pregnant woman if her healthcare provider believes that the benefits of the medication outweigh any possible risks to her unborn child.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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