Pregnancy outcome following gestational exposure to sibutramine: a prospective comparative study

Abstract

Sibutramine is a serotonin-norepinephrine reuptake inhibitor indicated for the treatment of obesity. High-dose reproductive studies in animals indicate some increase in risk, with no specific patterns. Currently, there is no data on its use or safety in humans, however, inadvertent exposure in pregnancy is inevitable due to unplanned pregnancies and its popularity among young women of childbearing age. Our objective is to determine the potential teratogenic concerns related to gestational exposure to sibutramine, examine its pattern of use in pregnancy, and the rationale behind it. Methods: This prospective, observational cohort study consists of pregnant women who contacted Motherisk regarding safety of sibutramine use in pregnancy. Details of maternal exposure and medical history (including BMI) will be documented with standardized intake forms. Sibutramine-exposed women will be compared to women exposed to non-teratogens (control) and all endpoints of interest will be assessed. Medical details will be verified by letters to physicians. Results: To date, all 16 women enrolled in the exposed group used it in the first trimester and no adverse pregnancy outcome has been reported. Most women initiated use based on peer recommendations, but BMI levels indicate that none qualified as obese. Conclusion: This ongoing study will be the first to address fetal safety after in utero sibutramine exposure, and provide insight to the logic behind use of this novel drug in pregnancy. Clinical Pharmacology & Therapeutics (2004) 75, P75–P75; doi: 10.1016/j.clpt.2003.11.282