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Sibutramine

Last reviewed dd mmm yyyy. Last edited dd mmm yyyy

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  • blocks noradrenaline and serotonin reuptake in the brain - this effect produces a feeling of satiety after smaller meals (1). It can be described as a serotonin and noradrenaline reuptake inhibitor (2)
  • sibutramine is taken for up to 12 months in conjunction with exercise and diet. It leads to a reduction in weight- and obesity-related co-morbidities (1). The weight reduction is greatest in the first 6 months of treatment (1). The use of sibutramine may also improve glycaemic control and reduce total cholesterol
  • sibutramine undergoes extensive first-pass metabolism in the liver, mainly by cytochrome P450 3A4. Concurrent use of cytochrome P450 inhibitors or inducers may increase or decrease plasma concentrations and thereby increase the unwanted effects or reduce any beneficial effects of sibutramine (2). Also concurrent use of drugs that result in increased levels of brain serotonin levels (such as antidepressants) may cause serotonin syndrome (2)
  • possible adverse effects include: constipation, headache, dry mouth, insomnia and anorexia; there is an increase in heart rate by 4-5 beats per minute and a rise in mean blood pressure associated with sibutramine treatment
    • treatment should be discontinued in patients who have a persistent increase in resting heart rate of >= 10 beats per minute or systolic/diastolic blood pressure of >= 10 mmHg (3)
    • patients should also be advised to urgently consult a doctor if symptoms usch as progressive dyspnoea, chest pain and ankle oedema occur (3)
  • sibutramine differs from orlistat in that it may only be prescribed to patients who have not adequately responded to an appropriate weight-reducing regimen (4)

The summary of product characteristics should be consulted before prescribing this drug.

Sibutramine: Suspension of marketing authorisation as risks outweigh benefits (21/1/10)

  • The European Medicines Agency (EMA) has completed a review of the obesity medicine sibutramine (Reductil) on the basis of new safety information from a large clinical trial, the Sibutramine Cardiovascular OUTcomes (SCOUT) study. The review has found that the cardiovascular risks of sibutramine outweigh its benefits. The EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended suspension of the marketing authorisation for this medicine across the European Union
  • further information is available on the EMA website.

Reference:

  1. GP (20 July 2001), 32.
  2. Drugs and Therapeutics Bulletin (2001), 39 (12), 89-91
  3. Current Problems in Pharmacovigilance (2003), 29, 7.
  4. Prescriber (2001), 12 (20), 75-81.

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