The clinical effectiveness and cost effectiveness of sibutramine for obesity.

This guidance has been replaced by CG43 Obesity

• Sibutramine (Reductil): marketing authorisation suspended

  On 21 January 2010, the MHRA announced the suspension of the marketing authorisation for the obesity drug sibutramine (Reductil). This follows a review by the European Medicines Agency which found that the cardiovascular risks of sibutramine outweigh its benefits. Emerging evidence suggests that there is an increased risk of non-fatal heart attacks and strokes with this medicine.

  The MHRA advises that:

  • Prescribers should not issue any new prescriptions for sibutramine (Reductil) and should review the treatment of patients taking the drug.
  • Pharmacists should stop dispensing Reductil and should advise patients to make an appointment to see their doctor at the next convenient time.
  • People who are currently taking Reductil should make a routine appointment with their doctor to discuss alternative measures to lose weight, including use of diet and exercise regimens. Patients may stop treatment before their appointment if they wish.

  NICE clinical guideline 43 recommended sibutramine for the treatment of obesity in certain circumstances. These recommendations have now been withdrawn and healthcare professionals should follow the MHRA advice.

• Other information

  How this guidance was produced

  Background information

  • Review of NICE Technology Appraisal Guidance Nos 22, orlistat and 31 sibutramine for the treatment of obesity in adults
  • 2001/32 NICE issues guidance on sibutramine for obesity
  • A systematic review of the clinical effectiveness and cost-effectiveness of sibutramine in the management of obesity
  • Review of NICE Technology Appraisal Guidance Nos 22, orlistat and 31 sibutramine for the treatment of obesity in adults

Guidance formats