Buprenorphine combined with naloxone is just as safe as buprenorphine alone for pregnant individuals with opioid use disorder (OUD), according to a report published yesterday in JAMA. For some complications such as neonatal abstinence syndrome, buprenorphine plus naloxone even appeared as the safer option.
Adding naloxone to buprenorphine is intended to deter diversion, because naloxone prevents buprenorphine’s euphoric effects when people try to take it intranasally or intravenously. “In pregnancy, buprenorphine alone is generally recommended because of limited perinatal safety data on the combination product,” wrote Loreen Straub, M.D., M.S., of Harvard Medical School, and colleagues.
To gain more insight into the risks of the combination product, Straub and colleagues made use of a Medicaid-based dataset that included rich patient-level information on mothers and their infants. They examined a range of maternal and neonatal outcomes among 3,369 pregnant individuals exposed to buprenorphine plus naloxone during the first trimester and 5,326 exposed to buprenorphine alone or who switched from the combination to buprenorphine alone by the end of the first trimester.
Compared with pregnant individuals who took buprenorphine alone, those who took the combination formula had a lower risk of having infants born with neonatal abstinence syndrome (37.4% versus 55.8%), infants who required neonatal intensive care (30.6% versus 34.9%), or infants who were small for their gestational age (10.0% versus 12.4%). The risk of other adverse outcomes, including congenital birth defects, preterm birth, respiratory problems in the infant, or severe maternal health problems post-delivery (such as heart attack or delirium), was similar with either medication type.
“This [study] supports the view that both formulations are reasonable options for treatment of OUD in pregnancy, affirming flexibility in collaborative treatment decision-making,” Straub and colleagues concluded.
For related information, see the American Journal of Psychiatry article “Flexible Buprenorphine/Naloxone Model of Care for Reducing Opioid Use in Individuals With Prescription-Type Opioid Use Disorder: An Open-Label, Pragmatic, Noninferiority Randomized Controlled Trial” and the related editorial “Flexible Buprenorphine/Naloxone Treatment Models: Safe and Effective in Reducing Opioid Use Among Persons With Prescription Opioid Use Disorder.”
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