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Arch Dis Child 95:856 doi:10.1136/adc.2010.190959
  • Postscript
  • Letters

European Medicines Agency withdrawal for sibutramine

  1. 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
  • Accepted 23 April 2010
  • Published Online First 23 June 2010

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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