S M St Clair1, R G Schirmer. 1. Worldwide Pharmacovigilance II Unit, Upjohn Company, Kalamazoo, Michigan.
Abstract
OBJECTIVE: To assess prospectively pregnancy outcome associated with first-trimester exposure to alprazolam in order to monitor for early signals of potential drug-related risk to the fetus. METHODS: Reports of first-trimester exposure to alprazolam from patients, physicians, or pharmacists were registered. Information regarding drug exposure, risk factors, and pregnancy outcome was requested at 4.5 and 9 months after registration. RESULTS: From June 1982 through December 1990, 542 pregnancies had been registered. Follow-up data were obtained on 411 registrants. There were 13 live births with congenital anomalies, 263 live births with no congenital anomalies, 47 spontaneous fetal losses, and 88 elective abortions. CONCLUSIONS: No pattern of defects or excess of defects or spontaneous abortions was apparent. Although these findings may provide some reassurance in counseling women following inadvertent prenatal exposure, the cases represent a sample of insufficient size for reaching reliable and definitive conclusions about the safety of alprazolam for pregnant women and their developing fetuses. The cases accumulated in this report represent a sample of insufficient size to confirm or refute previous reports of specific congenital anomalies linked to exposure to benzodiazepines.
OBJECTIVE: To assess prospectively pregnancy outcome associated with first-trimester exposure to alprazolam in order to monitor for early signals of potential drug-related risk to the fetus. METHODS: Reports of first-trimester exposure to alprazolam from patients, physicians, or pharmacists were registered. Information regarding drug exposure, risk factors, and pregnancy outcome was requested at 4.5 and 9 months after registration. RESULTS: From June 1982 through December 1990, 542 pregnancies had been registered. Follow-up data were obtained on 411 registrants. There were 13 live births with congenital anomalies, 263 live births with no congenital anomalies, 47 spontaneous fetal losses, and 88 elective abortions. CONCLUSIONS: No pattern of defects or excess of defects or spontaneous abortions was apparent. Although these findings may provide some reassurance in counseling women following inadvertent prenatal exposure, the cases represent a sample of insufficient size for reaching reliable and definitive conclusions about the safety of alprazolam for pregnant women and their developing fetuses. The cases accumulated in this report represent a sample of insufficient size to confirm or refute previous reports of specific congenital anomalies linked to exposure to benzodiazepines.