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Sibutramine (Reductil): marketing authorisation suspended

Newspage: DrugOn 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 These recommendations have now been withdrawn and healthcare professionals should follow the MHRA advice.

29 January 2010

This page was last updated: 11 February 2010

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Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.