Short Communication
International Journal of Obesity (2006) 30, 1315–1317. doi:10.1038/sj.ijo.0803268; published online 21 February 2006
Bruising associated with sibutramine: results from postmarketing surveillance in New Zealand
M Harrison-Woolrych1, G R Hill1 and D W J Clark2
- 1Intensive Medicines Monitoring Programme, Department of Preventive and Social Medicine, University of Otago, Dunedin, New Zealand
- 2Department of Pharmacology and Toxicology, School of Medical Sciences, University of Otago, Dunedin, New Zealand
Correspondence: Dr M Harrison Woolrych, Intensive Medicines Monitoring Programme, Department of Preventive and Social Medicine, University of Otago, P.O. Box 913, Dunedin, New Zealand. E-mail: Mira.harrison-woolrych@stonebow.otago.ac.nz
Received 6 October 2005; Revised 30 December 2005; Accepted 9 January 2006; Published online 21 February 2006.
Abstract
Objective:
To determine whether postmarketing data provide evidence of an association of sibutramine with bruising.
Design and patients:
During a postmarketing surveillance study of sibutramine in New Zealand by the Intensive Medicines Monitoring Programme (IMMP), a series of reports of bruising was identified. Further case reports were also obtained from the World Health Organisation (WHO) adverse drug reactions database.
Outcome measures:
All platelet, bleeding and clotting events associated with sibutramine were identified and causality assessments were performed.
Results:
From the IMMP and WHO databases a total of 16 cases of bruising that improved on withdrawal of sibutramine were identified. Of these, two had a recurrence of bruising on reintroduction of sibutramine.
Conclusions:
Evidence from postmarketing surveillance suggests that there is a causal association between sibutramine and bruising/ecchymosis. This represents a newly recognized adverse reaction for this medicine.
Keywords:
sibutramine, bruising, serotonin reuptake inhibitors, pharmacovigilance, bleeding
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