Fentanyl is a synthetic opioid analgesic approximately 100 times more potent than morphine. Fentanyl can be administered orally, intravenously, intranasally, topically (in the form of transdermal patches), epidurally or intrathecally.
Data regarding the use of fentanyl during pregnancy consist of a small number of published case reports, and pregnancy exposures (n=30) reported to UKTIS by healthcare professionals. Within these data, no congenital malformations were observed among the first trimester exposed cases (n=20). Three retrospective reports to UKTIS describe congenital malformations, however first trimester use was only confirmed in one case, concomitant medications were used, and no pattern of malformations was identified. The available data do not currently raise concerns about other adverse pregnancy outcomes or altered neurodevelopment in the child. However, data are too limited to permit an evidence-based assessment of these risks.
Use of any opioid during pregnancy, particularly around the time of delivery, confers a risk of neonatal respiratory depression. Prolonged use of opioids throughout pregnancy may also result in neonatal withdrawal. Where there is a compelling clinical indication for administration of fentanyl in the management of maternal pain or another condition, then use in pregnancy may be considered but at the lowest effective dose for the shortest period possible and should involve discussion with the patient regarding the lack of human pregnancy data.
Exposure to fentanyl at any stage of pregnancy would not usually be regarded as medical grounds for termination of pregnancy. The need for additional fetal monitoring or prenatal investigations should be decided on a case-by-case basis. Other risk factors may be present in individual cases which may independently increase the risk of adverse pregnancy outcome. Clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments. Infants exposed to fentanyl in utero for extended periods and/or around the time of delivery should ideally be delivered in a unit with facilities for the treatment and support of neonatal opioid withdrawal.
This is a summary of the full UKTIS monograph for health care professionals and should not be used in isolation. The full UKTIS monograph and access to any hyperlinked related documents is available to NHS health care professionals who are logged in.
If you have a patient with exposure to a drug or chemical and require assistance in making a patient-specific risk assessment, please telephone UKTIS on 0344 892 0909 to discuss the case with a teratology specialist.
If you would like to report a pregnancy to UKTIS please click here to download our pregnancy reporting form. Please encourage all women to complete an online reporting form.