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.
- Decreased respiration (decreased breathing)
- Changes in behavior, such as irritability, jitteriness, or restlessness
- Excessive or high-pitched crying
- Poor feeding