From the Guidelines
Tramadol should be avoided during pregnancy unless the potential benefits clearly outweigh the risks, and only after consultation with a healthcare provider. It is classified as a category C medication, meaning that animal studies have shown adverse effects on the fetus, but there are no adequate studies in pregnant women 1. Tramadol crosses the placenta and can cause neonatal withdrawal syndrome if used regularly near term. The risks include respiratory depression in the newborn, preterm birth, and potential developmental issues. For pain management during pregnancy, acetaminophen is generally considered the safest first-line option. If stronger pain relief is needed, healthcare providers may consider other options based on the stage of pregnancy, severity of pain, and individual risk factors. Any pain medication during pregnancy should be used at the lowest effective dose for the shortest duration possible. Women who are already taking tramadol and discover they are pregnant should not stop abruptly but should consult their healthcare provider immediately to discuss appropriate management.
Some key points to consider when managing pain in pregnant women include:
- The use of tramadol and other opioids can lead to neonatal abstinence syndrome, as seen in studies on neonatal drug withdrawal 1.
- The safety of buprenorphine in pregnancy has been demonstrated, and it may be a suitable alternative for some women 1.
- For migraine management during pregnancy, paracetamol is recommended as the first-line medication, and triptans should be used only under strict supervision due to limited safety data 1.
- Preventive migraine medications should be avoided during pregnancy, but propranolol or amitriptyline may be used under specialist supervision if clinically indicated.
Overall, the decision to use tramadol or any other medication during pregnancy should be made on a case-by-case basis, taking into account the potential benefits and risks to both the mother and the fetus.
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.
Tramadol use in pregnancy is not recommended unless the potential benefits outweigh the risks.
- The safe use of tramadol in pregnancy has not been established.
- Potential risks to the fetus include neonatal seizures, neonatal withdrawal syndrome, fetal death, and stillbirth.
- Use in pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus 2, 2.
From the Research
Tramadol Use During 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.
- The use of tramadol in early pregnancy may increase the risk of congenital malformations, particularly cardiovascular defects and pes equinovarus, although the risk increase is moderate 4.
General Considerations for Analgesic Use During Pregnancy
- Analgesics are commonly used during pregnancy, with over 60% of women self-reporting their use 5.
- Changes in renal filtration, cardiac output, plasma protein concentration, and plasma volume during pregnancy can affect analgesic disposition and may require dose adjustments 5.
- More research is needed to understand the risks and benefits of analgesic use during pregnancy, particularly as prevalence is rising 5.
- The use of opioids, including tramadol, during pregnancy can lead to neonatal abstinence syndrome, and treatment approaches are available 6.