Can I give levopront to a pregnant patient?

Can Levopront Be Given to Pregnant Patients?

Levopront (levorphanol) should not be given to pregnant patients except in rare circumstances where the benefits clearly outweigh substantial fetal risks, and only after careful consideration of safer alternatives.

FDA Drug Label Evidence

The FDA label for levorphanol provides critical safety information that should guide clinical decision-making:

• Animal studies demonstrate significant fetal harm: Levorphanol caused central nervous system malformations including neural tube defects (spinal cord kinking, hydromyelia, fourth ventricle dilation) in mice at 10 times the human dose, and approximately 50% embryo lethality at 12 times the human dose 1.

• Paternal exposure effects: Male mice exposed to levorphanol before mating produced offspring with reduced birth weights, developmental delays, and aberrant behavioral patterns at 34 times the human dose 1.

• Insufficient human data: Available data in pregnant women are inadequate to inform drug-associated risks for major birth defects and miscarriage 1.

Critical Pregnancy-Specific Risks

Neonatal Opioid Withdrawal Syndrome

• Extended opioid use during pregnancy causes neonatal opioid withdrawal syndrome, presenting as irritability, hyperactivity, abnormal sleep patterns, high-pitched cry, tremor, vomiting, diarrhea, and failure to gain weight 1.
• The onset, duration, and severity vary based on timing and amount of maternal use 1.
• Newborns require monitoring and management for withdrawal symptoms 1.

Labor and Delivery Complications

• Levorphanol is specifically not recommended during or immediately prior to labor when other analgesic techniques are more appropriate 1.
• Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates, requiring naloxone availability 1.
• The drug can prolong labor by reducing strength, duration, and frequency of uterine contractions 1.

Clinical Decision Algorithm

When faced with a pregnant patient requiring analgesia:

1. Avoid levorphanol as first-line therapy - The animal teratogenicity data and lack of human safety data make this a poor choice 1.

2. Consider safer alternatives - Other analgesics with better pregnancy safety profiles should be prioritized for pain management.

3. If levorphanol use is unavoidable (extremely rare circumstances):

   • Document clear justification for why safer alternatives are inadequate
   • Discuss all known risks with the patient, including neural tube defects, embryo lethality in animals, and neonatal withdrawal syndrome 1
   • Plan for neonatal monitoring and potential withdrawal management at delivery 1
   • Ensure naloxone availability for reversal of neonatal respiratory depression 1

4. Avoid use near term - Do not use during labor or immediately prior to delivery 1.

Lactation Considerations

• Levorphanol likely enters breast milk based on structural similarity to morphine, which is known to be excreted in human milk 1.
• Breastfed infants require monitoring for excess sedation and respiratory depression 1.
• Withdrawal symptoms can occur in breastfed infants when maternal opioid administration stops 1.
• A decision must be made whether to discontinue nursing or the drug, considering the importance of the drug to the mother 1.

Common Pitfalls to Avoid

• Do not assume opioid safety is equivalent across agents - Levorphanol has specific teratogenic concerns demonstrated in animal studies that may not apply to all opioids 1.
• Do not underestimate neonatal withdrawal risk - Extended use requires planning for neonatal care at delivery 1.
• Do not prescribe near delivery - The drug is contraindicated during labor when other options exist 1.