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

International Journal of Obesity volume 30, pages 1315–1317 (2006)Cite this article

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.

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Acknowledgements

We thank all the New Zealand doctors who actively support the IMMP and the staff of the WHO Uppsala Drug Monitoring Centre for extracting and supplying case details. The IMMP receives the majority of its funding from the New Zealand Ministry of Health. Whilst Abbott Australasia has provided some funding towards the cost of monitoring sibutramine, they have no role in the analysis or interpretation of IMMP data, nor in the decision to submit this article for publication.

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Authors and Affiliations

  1. Department of Preventive and Social Medicine, Intensive Medicines Monitoring Programme, University of Otago, Dunedin, New Zealand

    M Harrison-Woolrych & G R Hill

  2. Department of Pharmacology and Toxicology, School of Medical Sciences, University of Otago, Dunedin, New Zealand

    D W J Clark

Authors
  1. M Harrison-Woolrych
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  2. G R Hill
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  3. D W J Clark
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Correspondence to M Harrison-Woolrych.

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Harrison-Woolrych, M., Hill, G. & Clark, D. Bruising associated with sibutramine: results from postmarketing surveillance in New Zealand. Int J Obes 30, 1315–1317 (2006). https://doi.org/10.1038/sj.ijo.0803268

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