Immediate suspension of Sibutramine (Reductil)
On the 21st of January 2010 the European Medicines Agency (EMA) released a statement advising the suspension of sibutramine (Reductil) – a medicine for obesity management.
The Sibutramine Cardiovascular OUTcomes (SCOUT) study evaluated the use of sibutramine in patients with a history of cardiovascular disease and diabetes, 90% of whom would not have been eligible for sibutramine under the current label. The study showed that in this group of patients there was an increased risk of non-fatal heart attacks and strokes outweighing the benefits of weight loss. In Europe, but not in the USA or Australia, the regulatory authorities have suspended the license for all patients.
Sibutramine is offered to some patients as part of the Counterweight Treatment Pathway at 3 months, but always and only for those who met the product licence. Due to the withdrawal of sibutramine the treatment pathway will now only advise the use of orlistat for patients requiring pharmacotherapy to aid their weight management.
Further information is available at www.mhra.gov.uk and www.ema.europa.eu