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

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.

Prescription–Event Monitoring in New Zealand

“…• hypertension with moclobemide (Coulter and Pillans, 1995b) • fluoxetine and extrapyramidal effects (Coulter and Pillans, 1995a) • acute psychiatric reactions with the COX II inhibitors (Coulter, 2002) • acute visual impairment with rofecoxib and celecoxib • psoriasis associated with rofecoxib use (Clark and Coulter, 2003) • activation of pain by sumatriptan • nose bleeds associated with risperidone (Harrison-Woolrych and • amnesia associated with sibutramine • cardiac dysrhythmias with COX II inhibitors (Savage et al, 2005) • QT interval prolongation associated with sibutramine (Harrison-Woolrych et al, 2006a) • bruising associated with sibutramine (Harrison-Woolrych et al, 2006b) • alopecia associated with quetiapine (McLean and Harrison-Woolrych, 2007) • symptoms of depression in children prescribed risperidone • hair loss with use of the levonorgestrel intrauterine device (Paterson et al, 2007) • life-threatening clozapine-induced gastrointestinal hypomotility (Palmer et al, 2008) • withdrawal reactions to varenicline (Harrison-Woolrych and Ashton, 2011) • epistaxis and other hemorrhagic events associated with varenicline (Harrison-Woolrych et al, 2012) • memory impairment with varenicline the 18th Annual Meeting of National Centres Participating in the WHO International Drug Monitoring Programme, Portugal, 1996).…”

Patterns of Ecchymoses Caused by Manner of Death and Collateral Injuries Sustained in Bruising Incidents: Decedent Injuries, Profiles, Comparisons, and Clinicopathologic Significance

“…Contusions and ecchymoses can be isolated or part of a pattern of injury, as occurs in domestic abuse, elder abuse, accidents, or even natural disease (e.g. bleeding diatheses, drug reactions, or infectious diseases) (1–3,7,10–14). Contusion and ecchymoses can be because of many etiologies and can be associated with virtually any mechanism of injury or cause of death.…”