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


METHODS
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.


RESULTS
Seven cases of hypertensive complications were observed during pregnancies. No cases of congenital anomalies in neonates were observed.


CONCLUSIONS
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.
De Santis
Marco
M
Department of Obstetrics and Gynecology, Telefono Rosso - Teratology Information Service, Catholic University of the Sacred Heart, Rome, Italy. marcodesantis@rm.unicatt.it
Straface
Gianluca
G
Cavaliere
Anna F
AF
Carducci
Brigida
B
Caruso
Alessandro
A
D000014:Abnormalities, Drug-Induced / Q000453:epidemiology; D000328:Adult; D001067:Appetite Depressants / Q000009:adverse effects* / Q000627:therapeutic use; D015992:Body Mass Index; D003376:Counseling; D003503:Cyclobutanes / Q000009:adverse effects* / Q000627:therapeutic use; D004346:Drug Information Services; D005260:Female; D006801:Humans; D006973:Hypertension / Q000150:complications; D007231:Infant, Newborn; D007558:Italy / Q000453:epidemiology; D018811:Maternal Exposure / Q000009:adverse effects*; D009765:Obesity / Q000150:complications / Q000188:drug therapy*; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy*; D011256:Pregnancy Outcome / Q000453:epidemiology; D011261:Pregnancy Trimester, First / Q000187:drug effects; D011446:Prospective Studies; D012307:Risk Factors; D018600:Teratology
D001067:Appetite Depressants; D003503:Cyclobutanes; C058254:sibutramine