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Letters
European Medicines Agency withdrawal for sibutramine
  1. J Galhardo1,
  2. N Davis1,
  3. S Matthai2,
  4. J P Shield1
  1. 1Bristol Royal Hospital for Children, Bristol, UK
  2. 2Department of Paediatrics, Gloucestershire Royal Infirmary, Gloucester, UK
  1. Correspondence to Julian P Shield, Bristol Royal Hospital for Children, Upper Maudlin Street, Bristol BS2 8AE, UK; j.p.h.shield{at}bristol.ac.uk

https://doi.org/10.1136/adc.2010.190959

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    In January 2010, the European Medicines Agency withdrew its approval for sibutramine and the Food and Drug Administration has restricted its license based on concerns about a raised cardiovascular risk found in the Sibutramine Cardiovascular Outcome Trial (SCOUT) preliminary report.1 2 Despite being contraindicated in poorly controlled hypertension and cardiovascular disease, SCOUT only recruited patients ≥55 years old with known cardiovascular disease or type 2 diabetes plus ≥1 additional risk factor for cardiac disease. Moreover, patients were treated for 5 years, when the recommended period for clinical practice is 12 months. Given the premorbid characteristics of the SCOUT cohort, we …

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    Footnotes

    • Competing interests In the past, JPS received consultancy fees from the manufacturers of sibutramine.

    • Provenance and peer review Not commissioned; externally peer reviewed.