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Fetal Fentanyl Syndrome: New Study Links Fentanyl Use to Birth Defects

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Medically Reviewed By: Diana Vo, LMFT

December 13, 2023 (Originally Published)

May 21, 2024 (Last Updated)

Table of Contents

A recently published study has established a connection between a prenatal fentanyl exposure syndrome and at least 10 newborns. All of these babies exhibit distinctive features and various irregularities.

The research reveals that mothers who used fentanyl during pregnancy potentially exposed their infants to this newly identified syndrome. Recognizable characteristics associated with the syndrome include:

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  • Short stature at birth
  • Undersized heads (microcephaly)
  • Congenital issues like cleft palate, webbing between toes, and clubfoot

This emerging syndrome is part of a broader crisis involving fentanyl in the United States, highlighting the need for increased awareness and understanding of its implications on newborns as the U.S. opioid epidemic enters an especially damaging fourth wave.

How Fentanyl Continues to Drive the Opioid Epidemic

Fentanyl, a pharmaceutical medication prescribed by doctors for severe pain, is also illicitly manufactured and distributed by criminal organizations. According to DEA (United States Drug Enforcement Administration), a significant portion of illicit fentanyl in the U.S. is trafficked from Mexico, using chemicals sourced from China.

CDC (Centers for Disease Control and Prevention) report a sharp increase in drug overdose deaths over recent decades, with six times as many fatalities in 2021 than 1999. The first wave of the opioid epidemic mainly involved prescription painkillers which, despite their strong addictive potential, did not contribute to as many  fatal overdoses as synthetic opioids like fentanyl. Even by 2010, the total number of drug overdose deaths in the country remained below 40,000, with less than 10% attributed to fentanyl. This period, referred to as the second wave, saw fatalities primarily linked to the use of heroin or prescription opioids.

Starting in 2013, the third wave of the crisis marked a pronounced increase in overdose deaths associated with synthetic opioids, especially illicitly-manufactured fentanyl. The landscape of illicit fentanyl production is always changing, with the drug often found in combination with heroin, counterfeit pills, and cocaine. 2021 data show that 88% of fatal opioid overdoses in the United States involved fentanyl.

The researchers, in their study, raise concerns about a growing trend: deaths associated with the simultaneous use of fentanyl and other stimulant drugs such as cocaine or methamphetamine. This is already being flagged as the fourth wave of the opioid crisis.

woman looking at ultrasound representing Prenatal fentanyl exposure

What Happened During the Study?

During the summer of 2022, a study was conducted at Nemours Children’s Hospital in Wilmington, Delaware. The study focused on infants born from pregnancies complicated by nonprescription fentanyl exposure. The goal was to investigate physical issues associated with maternal fentanyl use. Karen W. Gripp, MD, who works at Nemours Children’s Health leading the Division of Medical Genetics at Nemours Children’s Health, observed distinctive facial features, short stature, small heads, and other physical irregularities among infants during this period.

The study targeted neonatal patients suspected of having SLOS (Smith-Lemli-Opitz syndrome) who had babies born after exposure to illicit fentanyl during pregnancy. Participants’ facial photographs were collected and evaluated with controls age-matched to those with suspected SLOS or FASDs (fetal alcohol spectrum disorders). None of the infants displayed the Smith-Lemli-Opitz variant or any other genetic markers associated with defects.

Identified features among children born from pregnancies marked by exposure to drugs like fentanyl included:

  • Cleft palate
  • Foot position irregularities
  • A single skin crease on palms
  • Genital anomalies
  • Rocker bottom foot (two digits fused together)

Previous research has established connections between prenatal exposure to opioids, whether from substances like fentanyl, heroin, morphine, or others, and the development of congenital problems such as cleft lip and palate.

The research also looked at specific substances in the body – high levels of 7-dehydrocholesterol or 8-dehydrocholesterol, for instance – to see if they could be signs of the new syndrome. Even after accounting for statistical accuracy, people with the new syndrome still stood out from the other groups in the study. Gripp, a pediatrician, hypothesizes that, “While direct testing of fentanyl’s impact on cholesterol metabolism hasn’t occurred, the authors suggest in the new report that, based on indirect evidence, it is plausible that fentanyl affects cholesterol metabolism in the developing fetus.”

Although the findings suggested a potential association between maternal fentanyl use and the newly identified syndrome, there were limitations in data regarding the timing and quantity of fentanyl used. Karen W. Gripp concluded that additional studies were essential to establish a definitive link between fentanyl use during pregnancy and the observed abnormalities. She also stressed the importance of recognizing this condition given the fentanyl use epidemic, stating that it could adversely impact infants in life-changing ways.

Although the newborns tested positive for fentanyl exposure at birth, the Nemours team suspects prolonged exposure to significant amounts of the drug throughout the entire pregnancies – “We need more work to confirm the findings, even to establish that it is unequivocally fentanyl and not any adulterants or other overlooked drugs.” Dr. Nora Volkow, the director of NIDA (National Institute on Drug Abuse), said that the situation was complex and that the women in the study were “also taking many drugs.

The researchers acknowledged that they have a substantial journey ahead to validate their hypothesis. This involves ensuring that the observed defects are not attributed to other street drugs or potential contamination in the consumed fentanyl. Additionally, the researchers aim to investigate the reasons behind instances where pregnant women using fentanyl do not witness similar symptoms in their babies.

If you are affected by fentanyl or you have a loved one who needs help tackling opioid use disorder, we can help you at Renaissance Recovery in Southern California.

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Get Compassionate Treatment for Fentanyl Addiction at Renaissance Recovery

While fentanyl addiction can be debilitating and disruptive, opioid use disorders respond favorably to treatment that combines medications approved by the FDA with behavioral interventions. We can help you move beyond fentanyl addiction at Renaissance Recovery Center in Southern California.

We offer a variety of outpatient treatment programs that enable you to address issues with fentanyl addiction without neglecting your everyday responsibilities. If you require a more immersive and structured recovery experience, consider our IOP (intensive outpatient program) or PHP (partial hospitalization program).

All Renaissance treatment programs blend the following therapies for a personalized and compassionate approach to recovery from fentanyl addiction:

Call 866.330.9449 when you are ready to tackle fentanyl addiction head-on.



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Joseph Gilmore has been in the addiction industry for three years with experience working for facilities all across the country. Connect with Joe on LinkedIn.

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