Bruising associated with sibutramine: results from postmarketing surveillance in New Zealand.
OBJECTIVE
To determine whether postmarketing data provide evidence of an association of sibutramine with bruising.


METHODS
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.


METHODS
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.
Intensive Medicines Monitoring Programme, Department of Preventive and Social Medicine, University of Otago, Dunedin, New Zealand. Mira.harrison-woolrych@stonebow.otago.ac.nz
M
M
Harrison-Woolrych
G R
GR
Hill
D W J
DW
Clark
D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D001067:Appetite Depressants / Q000009:adverse effects* / Q000627:therapeutic use; D003288:Contusions / Q000209:etiology*; D003503:Cyclobutanes / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008875:Middle Aged; D009520:New Zealand; D011358:Product Surveillance, Postmarketing; D014944:World Health Organization
D001067:Appetite Depressants; D003503:Cyclobutanes; C058254:sibutramine