From the Guidelines
Tramadol should be avoided during pregnancy unless the potential benefit outweighs the risks, and only under direct medical supervision. The use of tramadol during pregnancy is a complex issue, and the decision to use it requires careful consideration of the severity of pain, available alternatives, and potential risks to both mother and fetus 1. According to the most recent evidence, paracetamol (acetaminophen) is the preferred first-line medication for pain management during pregnancy due to its better safety profile 1.
Key Considerations
- Tramadol is classified as a Category C medication by the FDA, meaning that animal studies have shown adverse effects on the fetus, but there are no adequate studies in pregnant women.
- Tramadol should be avoided particularly during the first trimester when organ formation occurs and in the third trimester as it may cause neonatal withdrawal syndrome in newborns if used regularly near delivery.
- Any pain medication during pregnancy should only be used under direct medical supervision.
- Patients who are pregnant or planning pregnancy should discuss all medications with their healthcare provider to determine the safest approach to pain management.
Alternative Options
- Acetaminophen is typically considered the first-line pain medication during pregnancy due to its better safety profile 1.
- NSAIDs can be used only during the second trimester, but with caution and under medical supervision 1.
- Other medications, such as metoclopramide, can be used for nausea associated with migraine in pregnancy, but under specialist supervision 1.
Conclusion is not allowed, so the answer ends here.
From the FDA Drug Label
Tramadol hydrochloride should not be used in pregnant women prior to or during labor unless the potential benefits outweigh the risks. Safe use in pregnancy has not been established. Tramadol hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pregnancy and Tramadol:
- Key Points:
- Tramadol should not be used in pregnant women unless the potential benefits outweigh the risks.
- Safe use in pregnancy has not been established.
- Use during pregnancy may lead to physical dependence and post-partum withdrawal symptoms in the newborn.
- Recommendation: Tramadol can be used in pregnant patients only if the potential benefit justifies the potential risk to the fetus 2, 2.
From the Research
Tramadol Use in Pregnancy
- Tramadol is an opioid that freely crosses the placenta, posing a risk of neonatal withdrawal symptoms 3.
- Chronic use of tramadol during pregnancy is not advised due to the risk of neonatal abstinence syndrome 3.
- A study found that a newborn developed neonatal withdrawal symptoms 36 hours after delivery when the mother used tramadol during pregnancy, and treatment with phenobarbital was effective 3.
- There is limited clinical research on the use of tramadol in pregnancy and lactation, as it is not licensed for use in this patient population 4.
Risks Associated with Tramadol Use in Pregnancy
- Tramadol use in early pregnancy may be associated with a moderate increase in the risk of congenital malformations, particularly cardiovascular defects and pes equinovarus 5.
- The use of opioids, including tramadol, during pregnancy may increase the risk of preeclampsia and preterm birth 6.
- Neonatal abstinence syndrome may occur after the use of opioids, including tramadol, for chronic pain during pregnancy 6.
Alternative Pain Management Options
- Acetaminophen is considered an acceptable option for pain management during pregnancy 6.
- Triptans, such as sumatriptan, can be used for migraine during pregnancy, but ergots are preferably avoided due to limited data 6.
- The use of non-steroid anti-inflammatory drugs (NSAIDs) should be avoided during the first trimester and late pregnancy due to the risk of bleeding and premature closure of the ductus arteriosus 6.