This report examines monthly extended-release buprenorphine injections (SUBLOCADE) during pregnancy using four clinical cases, 322 postmarketing pregnancy exposure reports, and a review of published literature. All four infants in the case series were born at term, had normal birthweights, and did not require medication for neonatal opioid withdrawal. Birth outcomes were known for only 68 of the surveillance reports. Although the authors found no new safety signal in the available evidence, the small case series and incomplete observational reports cannot establish definitive maternal or infant safety; individualized treatment decisions and further follow-up remain important.
