Summary points (1):
- sibutramine should be prescribed only as part of an overall plan for managing obesity in adults who meet one of the following criteria:
- a BMI of 27.0 kg/m2 or more and other obesity-related risk factors such as type 2 diabetes or dyslipidaemia
- a BMI of 30.0 kg/m2 or more
- sibutramine should not be prescribed unless there are adequate arrangements for monitoring both weight loss and adverse effects (specifically pulse and blood pressure)
- therapy should be continued beyond 3 months only if the person has lost at least 5% of their initial body weight since starting drug treatment
- treatment is not currently recommended beyond the licensed duration of 12 months
- coprescribing of sibutramine with other drugs aimed at weight reduction is not recommended
Some points from previous guidance (2):
- sibutramine should only be prescribed in accordance with the summary of product characteristics. This drug should only be prescribed for people who have made serious attempts to lose weight by diet, exercise and/or other behavioural modifications
- sibutramine may increase blood pressure and therefore blood pressure should be regularly measured in all those prescribed with sibutramine. If there is an increase in blood pressure then continuation of treatment of sibutramine should be considered in terms of risks and benefits of the cardiovascular risk profile for the individual.
- it is not recommended that treatment with sibutramine be given to individuals with a blood pressure > 140/90 mmHg before start of therapy
- treatment with sibutramine should be stopped if blood pressure rises above 140/90 mmHg or by more than 10mmHg (systolic or diastolic) or whose resting pulse rate rises by more than 10 beats per minute
The summary of product characteristics must 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.
- NICE (December 2006). Obesity guidance.
- NICE (October 2001, Issue 3). Summary of Guidance Issued to the NHS in England and Wales, Sibutramine for obesity in adults.