What are the FDA pregnancy categories for Midazolam (Versed), Propofol, Fentanyl, and Meperidine, and are they safe to use during breastfeeding?

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Last updated: May 16, 2025View editorial policy

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From the Guidelines

For colonoscopy sedation medications and breastfeeding, I recommend resuming breastfeeding as soon as the woman has recovered from the procedure after receiving midazolam (Versed, FDA Category D) 1, waiting 4 hours after propofol (FDA Category B) 1, 4-6 hours after fentanyl (FDA Category C) 1, and 4-6 hours after meperidine (Demerol, FDA Category B) 1 before resuming breastfeeding. The FDA category classifications for these medications are as follows:

  • Midazolam: D
  • Propofol: B
  • Fentanyl: C
  • Meperidine: B Key considerations for each medication include:
  • Midazolam: extensive first-pass metabolism results in low systemic bioavailability after oral doses, so blood levels in the infant after breastfeeding can be expected to be low 1
  • Propofol: rapidly cleared from the bloodstream with minimal transfer to breast milk, making the 4-hour waiting period generally sufficient 1
  • Fentanyl and meperidine: opioids that can transfer to breast milk, potentially causing respiratory depression in infants, so waiting 4-6 hours allows for significant clearance 1 For all medications, mothers should pump and discard milk during the waiting period to maintain supply, and should monitor their infant for unusual drowsiness, difficulty breathing, or poor feeding after resuming breastfeeding. These recommendations balance medication safety with the importance of continued breastfeeding, as the actual amount of medication transferred through breast milk after these waiting periods is typically minimal.

From the FDA Drug Label

Meperidine:

  • Nursing Mothers Meperidine appears in the milk of nursing mothers receiving the drug Due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the potential benefits of the drug to the nursing woman.

Propofol:

  • Propofol is not recommended for use in nursing mothers because propofol injectable emulsion has been reported to be excreted in human milk, and the effects of oral absorption of small amounts of propofol are not known

There is no information about Versed (Midazolam) and Fentanyl in the provided drug labels. The FDA category class for:

  • Meperidine is C 2
  • Propofol is not explicitly stated in the provided label, but it is known to be B For colonoscopy and breastfeeding:
  • Meperidine: a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the potential benefits of the drug to the nursing woman 2
  • Propofol: not recommended for use in nursing mothers because it is excreted in human milk 3

From the Research

FDA Category Class for Sedation Medications

  • Versed (Midazolam): FDA category D [(4,5,6,7,8)]
  • Propofol: FDA category B [(4,5,7,8)]
  • Fentanyl: FDA category C [(4,5,6,7,8)]
  • Meperidine: FDA category C [(4,5,6)]

Breastfeeding Recommendations

  • Versed (Midazolam): use with caution, as it may pass into breast milk [(4,5,6,7,8)]
  • Propofol: use with caution, as it may pass into breast milk [(4,5,7,8)]
  • Fentanyl: use with caution, as it may pass into breast milk [(4,5,6,7,8)]
  • Meperidine: use with caution, as it may pass into breast milk [(4,5,6)]

Sedation Medication Comparison

  • Propofol has a faster recovery time and higher patient satisfaction compared to midazolam and fentanyl [(4,5,7,8)]
  • Fentanyl has a faster recovery time compared to meperidine when used with midazolam 6
  • Propofol has a lower risk of cardiopulmonary complications compared to traditional sedative agents for colonoscopy 7

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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