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Onsolis and Breastfeeding

According to the manufacturer of Onsolis (fentanyl buccal soluble film), women should avoid using this medication while breastfeeding. Research studies have shown that the active ingredient passes through breast milk and may cause potentially serious problems in the infant, such as poor feeding or difficulty breathing. Before using Onsolis, breastfeeding women should ask their healthcare providers about the potential risks.

Is Onsolis Safe to Use While Breastfeeding?

Onsolis™ (fentanyl buccal soluble film) is prescription pain medication licensed to manage breakthrough pain in people with cancer who are already taking regularly scheduled opioid narcotic medication for their constant pain. This drug is known to pass through breast milk, and the manufacturer recommends that women avoid using Onsolis while breastfeeding.
If you are breastfeeding or thinking about breastfeeding, you should talk to your healthcare provider before using this medication.

More Information on Breastfeeding and Onsolis

Fentanyl, the active ingredient in Onsolis, passes through breast milk. While the amount of fentanyl passed through is thought to be small, most studies have looked at single fentanyl doses. There is very little information available about the effects of repeated fentanyl doses, which would be the case with Onsolis use.
Exposing an infant to fentanyl may lead to serious problems, including drowsiness, difficulty feeding (which could cause problems gaining weight), or breathing problems. In addition, the infant may experience opioid withdrawal symptoms when breastfeeding is stopped. Such signs of withdrawal could include but are not limited to:
  • High-pitched crying
  • Irritability
  • Shakiness (tremors)
  • Difficulty feeding.
While the manufacturer recommends Onsolis not be used in women who are breastfeeding, some experts (such as the American Academy of Pediatrics) generally consider fentanyl compatible with breastfeeding, which means it is probably safe.
If your healthcare provider recommends Onsolis while breastfeeding, make sure to watch for any problems in your infant, such as:
  • Breathing problems, including slow and shallow breaths
  • Difficulty feeding
  • Extreme sleepiness.
If you notice any of these problems, or if something "just does not seem right," immediately contact your healthcare provider.
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