Early first-trimester sibutramine exposure : pregnancy outcome and neonatal follow-up

Drug Safety : an International Journal of Medical Toxicology and Drug Experience
Marco De SantisAlessandro Caruso

Abstract

Sibutramine is a drug that is used in the treatment of obesity. There are currently no epidemiological studies relating to sibutramine exposure in pregnancy. The objective of our study was to determine whether sibutramine exposure during pregnancy constitutes a risk factor to the mother and developing fetus. Fifty-two pregnant women who were exposed to sibutramine in the first trimester of pregnancy, when they were unaware of being pregnant, contacted our Teratology Information Service. We recorded the prospective outcomes of this case series between May 2001 and September 2004 with a complete neonatal follow-up up to 1 month after delivery. Seven cases of hypertensive complications were observed during pregnancies. No cases of congenital anomalies in neonates were observed. Although many more cases are necessary to demonstrate that sibutramine is not teratogenic in pregnancy, our experience improves the counseling of pregnancies occurring involuntarily during sibutramine therapy.

References

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Citations

Dec 2, 2014·Obesity Research & Clinical Practice·Bengt A J Källén
Jun 22, 2010·Journal of Toxicology and Environmental Health. Part a·Luis Alberto Domingo Francia-FarjeWilma De Grava Kempinas
Aug 2, 2008·Expert Opinion on Pharmacotherapy·Bikash Sharma, David C Henderson
Aug 11, 2007·Expert Opinion on Drug Safety·Bengt Källén
Sep 16, 2009·The Journal of Obstetrics and Gynaecology Research·Filiz CayanSaffet Dilek
Sep 18, 2007·Obesity Reviews : an Official Journal of the International Association for the Study of Obesity·M MetwallyW L Ledger
Jan 7, 2010·Human & Experimental Toxicology·Cristiano José da SilvaCatarina Satie Takahashi

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