Sibutramine Use in Pregnancy: Report of Two Cases

Mine Kadioglu,1* Cunay Ulku,1 Fusun Yaris,2 Murat Kesim,1 Nuri Ihsan Kalyoncu,1 and Ersin Yaris1

1Department of Pharmacology, School of Medicine, Karadeniz Technical University, Trabzon, Turkey2Department of Family Medicine, School of Medicine, Karadeniz Technical University, Trabzon, Turkey

Received 7 April 2004; Accepted 26 May 2004

BACKGROUND: Sibutramine is a drug used for the medical treatment of obesity. No data are available onsibutramine use in pregnancy. We report the fetal outcomes of two pregnant women exposed to sibutramine.CASES: The first woman was exposed to 10 mg/day of sibutramine during gestational weeks 4–6. The secondwoman was exposed to 10 mg/day of sibutramine during gestational weeks 5–8. At weeks 37 and 39, theydelivered healthy infants. CONCLUSIONS: To our knowledge, this is the first report of sibutramine exposurein pregnancy. These cases may contribute to the knowledge about sibutramine use during pregnancy. BirthDefects Research (Part A) 70:545–546, 2004. © 2004 Wiley-Liss, Inc.

Key words: pregnancy; sibutramine; obesity

INTRODUCTION

There has been an epidemic of obesity in the last decade.In spite of the rising numbers of overweight and obesepeople, medical treatment of obesity includes only a fewkinds of drugs (Schurgin and Siegel, 2003). Sibutramine isa new drug that has both serotonin and norepinephrinereuptake inhibitory properties. It acts by inhibiting foodintake and reducing hunger perception (Caterson, 1999;Sanders-Bush and Mayer, 2001; Gokcel et al., 2002; Ale-many et al., 2003). Little is known about the risks associ-ated with prenatal exposure to the new drug, and no dataare available in the literature about sibutramine use inpregnancy.

Among the 600 cases exposed to drugs during preg-nancy that were followed by our center over five years;there were four women who used sibutramine during theirunplanned pregnancies. Two women decided to terminatetheir pregnancies because of the lack of data about thesafety of this drug. The other two women continued theirpregnancies after cessation of the drug..

CASES

Case 1, a 32-year-old, obese (body mass index [BMI] �42 kg/m2), hypertensive Caucasian multigravida, was ex-posed to 10 mg/day of sibutramine during gestationalweeks 4–6. She had also used 25 mg/day of metoprololand 100 mg/day of flurbiprofen on an irregular basis. Herhypertension was controlled by switching to 250 mg/dayof alpha-methyldopa. Two lumbar radiographs were takenin gestational week 4. She was married to her secondcousin. A triple screen in gestational week 17 was normal,and fetal ultrasonography was unremarkable.

At 37 weeks, she delivered a male infant (3850 gm; 53cm) by cesarean section because of complete breech pre-sentation. The infant had APGAR scores of 7 and 9, at 1and 5 min, respectively. We followed the baby for 18months, during which time no major or minor anomaly ordevelopmental problems were found.

Case 2, a 30-year-old, obese (BMI � 39 kg/m2) Cauca-sian multigravida, was exposed to 10 mg/day of sibutra-mine during gestational weeks 5–8. No other risk factorswere identified. All obstetrical and ultrasonographicalfindings were normal during the pregnancy. At 39 weeks,she delivered a male infant (3500 gm; 50 cm) by cesareansection because of her lumbar disk herniation. APGARscores were 6 and 8, at 1 and 5 min, respectively. Wefollowed the baby for two months, during which time nomajor or minor anomaly or developmental problems werefound.

DISCUSSION

Pharmacotherapy during pregnancy requires an assess-ment of the risks and benefits of the treatment for both themother and fetus. Obesity is a common problem in womenduring their childbearing years, and pharmacotherapymay be used in its management (Schurgin and Siegel,

*Corresponding address: Mine Kadioglu, Karadeniz Technical University,School of Medicine, Department of Pharmacology, TR-61187 Trabzon, Turkey.E-mail: mkadioglu@meds.ktu.edu.trPublished online 21 July 2004 in Wiley InterScience (www.interscience.wiley.com).DOI: 10.1002/bdra.20052

© 2004 Wiley-Liss, Inc. Birth Defects Research (Part A) 70:545–546 (2004)

Birth Defects Research (Part A): Clinical and Molecular Teratology 70:545–546 (2004)

2003). For new drugs, such as sibutramine, data for theirsafe use during pregnancy are not available.

To our knowledge, this is the first report of fetal outcomeafter sibutramine use in pregnant women. The normalpregnancy outcomes in these two cases do not establish thesafety of this drug for use in pregnancy, but these data docontribute to the limited knowledge regarding its possiblereproductive toxicity.

ACKNOWLEDGMENTWe thank Ms. Janice O. Vantrease for the valuable re-

view of the manuscript for English grammar.

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