Cancer Home > Onsolis and Pregnancy

In studies on the active ingredient in Onsolis (fentanyl buccal soluble film), miscarriages and reduced body weights occurred in the offspring when the drug was given to pregnant animals. Onsolis does pass through the placenta to an unborn child and may cause the baby to become dependent on the drug. After birth, this may lead to withdrawal symptoms, such as seizures and breathing problems.

Can Pregnant Women Use Onsolis?

Onsolis™ (fentanyl buccal soluble film) 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). Onsolis 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.
 
Onsolis has not been studied in pregnant women. In animal studies, fentanyl (the active ingredient in Onsolis) caused miscarriages 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. Signs 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 Onsolis, 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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