Buprenorphine combined with naloxone does not increase the risk of major congenital malformations in pregnant women with opioid use disorder, a Journal of the American Medical Association study has found. 

While buprenorphine-naloxone is commonly used for opioid use disorder, the lack of perinatal safety data has limited use in pregnant women, Harvard Medical School researchers said.

Their study looked at a Medicaid dataset covering 3369 pregnant women in the US who were exposed to buprenorphine-naloxone in the first trimester, along with 5326 women exposed to buprenorphine alone.

“This study increased the number of buprenorphine/naloxone-exposed dyads reported in the literature by nearly 10-fold,” they said.