Is tramadol (opioid analgesic) contraindicated in pregnancy?

Tramadol Use in Pregnancy: Safety Concerns and Contraindications

Tramadol is contraindicated in pregnancy due to risks of neonatal withdrawal syndrome, potential fetal toxicity, and adverse maternal and neonatal outcomes. 1

Evidence of Harm in Pregnancy

• The FDA drug label explicitly states that tramadol has been shown to be embryotoxic and fetotoxic in animal studies, with decreased fetal weights, skeletal ossification issues, and increased supernumerary ribs observed at maternally toxic dose levels 1
• Tramadol crosses the placenta freely due to its lipophilic characteristics, with a mean ratio of serum tramadol in umbilical veins compared to maternal veins of 0.83 1
• Neonatal seizures, withdrawal syndrome, fetal death, and stillbirth have been reported in post-marketing surveillance of tramadol use during pregnancy 1
• Case reports document neonatal abstinence syndrome developing in infants born to mothers who used tramadol during pregnancy, requiring treatment with phenobarbital 2

Specific Risks to Neonates

• Tramadol use during pregnancy can lead to physical dependence and post-partum withdrawal symptoms in newborns 1
• A 2022 study found that tramadol exposure during late pregnancy carries a risk of neonatal opioid withdrawal syndrome (NOWS), with risk comparable to hydrocodone but lower than strong opioid agonists 3
• The FDA label clearly states that tramadol should not be used in pregnant women prior to or during labor unless potential benefits outweigh the risks 1

Recommendations for Pain Management in Pregnancy

• For pregnant women requiring pain management, NSAIDs and acetaminophen should be first-line treatments (unless contraindicated) rather than opioids like tramadol 4
• For pregnant women with opioid use disorder, methadone and buprenorphine are the only opioids considered safe for use throughout all trimesters of pregnancy 4
• The American College of Obstetricians and Gynecologists recommends that methadone or buprenorphine should not be abruptly discontinued during pregnancy as withdrawal poses risks to both mother and fetus 4

Breastfeeding Considerations

• Tramadol is not recommended for obstetrical preoperative medication or post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied 1
• Studies have detected tramadol and its metabolites in breast milk and in neonatal oral fluid, indicating exposure to the infant during breastfeeding 5
• The CDC recommends that codeine (another opioid) should be avoided during breastfeeding due to reports of neonatal toxicity and death, raising similar concerns for tramadol 4

Alternative Approaches

• For labor pain, neuraxial analgesia (epidural) should be encouraged rather than systemic opioids 4
• For postpartum pain, a multimodal approach starting with non-opioid pain relief is recommended 4
• When opioids are necessary for severe pain in pregnancy, they should be used at the lowest effective dose for the shortest duration possible, with careful monitoring of both mother and fetus 6

Important Clinical Considerations

• Delivery for women who have used tramadol during pregnancy should take place in a facility prepared to monitor, evaluate, and treat neonatal opioid withdrawal syndrome 6
• Healthcare providers should discuss family planning with reproductive-age women before initiating opioid therapy for chronic pain, including how long-term opioid use might affect future pregnancies 6
• Clinicians should consider tapering opioids during pregnancy only with appropriate expertise due to potential risks to both the pregnant patient and fetus if withdrawal occurs 6