Details
This analysis evaluated the risks of congenital cardiac malformations and oral clefts after in utero exposure to cyclobenzaprine and comparators during the first trimester of pregnancy, among females 15 years of age and older with linked live birth deliveries in the Sentinel Distributed Database. Comparator cohorts included (1) unexposed, (2) exposed to nonsteroidal anti-inflammatory drugs (NSAID) without receiving cyclobenzaprine, acetaminophen, and any opioids during pregnancy, and (3) exposed to acetaminophen without receiving cyclobenzaprine, NSAIDs, and any opioids during pregnancy.
The study period includes data from January 1, 2012 to August 31, 2025. We distributed this request to six Sentinel Data Partners on June 24, 2026.
The analytic packages associated with this analysis can be found externally in Sentinel's Git Repository located here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.