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Notice of Special Interest (NOSI): Consequences of Prenatal Fentanyl Exposure

National Institutes of Health

The opioid epidemic has led to a rise in opioid misuse among pregnant women posing unique challenges and risks to maternal and especially fetal health. Little is known about prenatal effects of fentanyl, a synthetic opioid increasingly present in unregulated drug supply and increasingly misused during pregnancy.

Given the pharmacology of fentanyl, its use during pregnancy may produce unique effects in the fetus and newborn. Preclinical studies of prenatal fentanyl exposure in rodent models revealed smaller litter sizes and higher litter mortality rates of pups, and somatosensory impairments in surviving animals.

In humans, fentanyl transfer across placenta was documented in early pregnancies, and the drug was confirmed in fetal brain tissue. A single-center, retrospective cohort study revealed prenatal fentanyl as one of the risk factors most strongly associated with the need for inotrope treatment in hypotensive very low gestational age infants. Even more worrying is the recent report on a novel syndrome associated with prenatal fentanyl exposure. Ten newborns, all prenatally exposed to nonprescription fentanyl, shared microcephaly, distinctive facial features, cleft palate, feeding difficulties, and congenital anomalies of hands and feet. The similarity with Smith-Lemli-Opitz syndrome (SLOS), suggests abnormalities in prenatal cholesterol metabolism, but the mechanism through which fentanyl might interfere with cholesterol synthesis is unclear.

The purpose of this Notice of Special Interest (NOSI) is to promote research on neurobehavioral, neurological, and potential teratogenic effects of prenatal fentanyl exposure in humans and in animal models.

This notice applies to due dates on or after June 5, 2025 and subsequent receipt dates through September 8, 2028.

NOT-DA-26-003

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Medical

Medical - Clinical Science

Medical - Basic Science

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Sponsor Details

Sponsor Institute/Organizations: National Institutes of Health

Address: National Institutes of Health; 31 Center Drive; MSC 2220; Bethesda; MD 20892-2220; USA

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