Is it safe to administer fentanyl to a woman at 14 weeks gestation?

From the Guidelines

Fentanyl can be used cautiously in pregnant women, including at 14 weeks gestation, when the benefits outweigh the risks. The use of fentanyl in pregnancy is supported by recent guidelines, which suggest that it can be used for pain management during pregnancy, including during surgery or for severe pain that cannot be managed with safer alternatives 1. According to the American Journal of Obstetrics and Gynecology, fentanyl is considered a Category C medication in pregnancy, meaning it should be used only when clearly needed for pain management 1.

Key Considerations

• The dosing of fentanyl should be determined by a healthcare provider based on the specific clinical situation, typically starting with the lowest effective dose 1.
• Short-term use of fentanyl is generally considered safer than prolonged exposure 1.
• While fentanyl crosses the placenta, short-term use for acute pain management has not been definitively linked to birth defects 1.
• However, regular or long-term use, especially later in pregnancy, can potentially lead to neonatal opioid withdrawal syndrome after birth 1.
• Alternative pain management strategies should be considered first when possible, and the medication should only be administered under close medical supervision 1.

Additional Guidance

• A recent study published in the American Journal of Obstetrics and Gynecology suggests that postpartum pain should be managed with a multimodal approach that starts with nonopioid pain relief, and if pain persists for more than 24 hours, a full opioid agonist such as fentanyl or hydromorphone may be ordered 1.
• The use of fentanyl in pregnant women with opioid use disorder (OUD) requires careful consideration, and the medication should be used in conjunction with other pain management strategies, such as nonopioid medications and regional anesthesia 1.
• Women with OUD should be encouraged to breastfeed and room in with the baby, as both have been shown to improve outcomes for mother and baby and may decrease pain medication use for the mother 1.

From the FDA Drug Label

Pregnancy Teratogenic Effects. Pregnancy Category C No epidemiological studies of congenital anomalies in infants born to women treated with fentanyl during pregnancy have been reported. The potential effects of fentanyl on embryo-fetal development were studied in the rat, mouse, and rabbit models Fentanyl transdermal system should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus

The administration of fentanyl to a woman at 14 weeks gestation is not recommended without careful consideration of the potential risks to the fetus. Fentanyl should only be used during pregnancy if the potential benefit justifies the potential risk. There are no adequate and well-controlled studies in pregnant women to provide clear guidance on the safety of fentanyl use during pregnancy 2.

From the Research

Safety of Fentanyl Administration in Pregnancy

• The safety of administering fentanyl to a woman at 14 weeks gestation is a concern due to the potential risks to the fetus 3.
• According to a review of analgesics in pregnancy, over 50% of analgesics are in pregnancy category C, and even more are category D specifically in the third trimester, indicating potential risks to the fetus 3.
• Changes in renal filtration, cardiac output, plasma protein concentration, and plasma volume during pregnancy can affect the disposition of analgesics, including fentanyl, and dose adjustments may be necessary to maintain therapeutic concentrations and protect the developing fetus 3.

Use of Fentanyl in Labor Pain Management

• Fentanyl is one of the short-acting opioids recommended by the World Health Organization for pain relief during labor 4.
• A scoping review of the use of fentanyl for labor pain management found that the studies were conducted in high-income countries, and the majority of the studies used intravenous or epidural fentanyl 4.
• The review highlighted the need for high-quality research to establish the most effective route of fentanyl and associated effects for evidence-based international guidelines 4.

Opioids for Cancer Pain and Other Conditions

• Opioids, including fentanyl, are commonly used to treat moderate or severe cancer pain, and are recommended for this purpose in the World Health Organization pain treatment ladder 5.
• A review of opioids for cancer pain found that the evidence quality was very low for all outcomes, but the available evidence indicated that around 19 out of 20 people with moderate or severe pain who were given opioids and could tolerate them should have their pain reduced to mild or no pain within 14 days 5.
• Fentanyl is also used to treat noncancer-related pain, including neuropathic pain, and has been shown to be effective in improving neuropathic pain symptoms 6.

Considerations for Fentanyl Administration in Pregnancy

• When considering the administration of fentanyl to a woman at 14 weeks gestation, it is essential to weigh the benefits and risks, taking into account the potential effects on the fetus and the mother's health 3, 4.
• The use of fentanyl in pregnancy should be guided by evidence-based guidelines and recommendations, and healthcare providers should carefully monitor the mother and fetus for any potential adverse effects 7.