Prescribing sibutramine (1):
- normally starting dose is 10mg per day
- continuation of therapy beyond 4 weeks should be supported by evidence of 2 kg weight loss and beyond 3 months by evidence of a weight loss of at least 5% of initial body weight
- dosage may be increased to 15mg per day after 4 weeks in line with sibutramine's Summary of Product Characteristics, and the same treatment and monitoring regimens followed as for the 10mg/day dose. Sibutramine should be stopped if there is inadequate response as defined above
- treatment is not recommended beyond the licensed indication of 12 months
- no evidence to support co-prescribing of sibutramine with other pharmacotherapy aimed at weight reduction
In light of the possible side effects of raised blood pressure and increase in heart rate, two-weekly monitoring of pulse and blood pressure is recommended for the first three months of treatment. Treatment with sibutramine should be discontinued if resting heart rate increases by more than 10 beats per minute or blood pressure by more than 10 mmHg on two consecutive visits (2).
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
The summary of product characteristics should be consulted before prescribing this drug.
Reference:
- (1) NICE (October 2001, Issue 3). Summary of Guidance Issued to the NHS in England and Wales, Sibutramine for obesity in adults.
- (2) Prescriber (2001), 12 (20), 75-81.