Bruising associated with sibutramine: results from postmarketing surveillance in New Zealand.

Abstract

To determine whether postmarketing data provide evidence of an association of sibutramine with bruising. 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. All platelet, bleeding and clotting events associated with sibutramine were identified and causality assessments were performed. 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. 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.