A slimming pill should be withdrawn because it can “lead to an increased risk of heart attacks and strokes”, The Times and other newspapers reported. It said that the European Medicines Agency (EMA) has recommended that sibutramine, marketed as Reductil, should no longer be prescribed by doctors or dispensed by pharmacists.
The new advice is based on findings from a clinical trial that showed use of the drug was associated with an increased risk of serious, non-fatal cardiovascular events, such as stroke or heart attack, compared to a placebo.
The drugs, together with diet and exercise, are used to promote weight loss in obese and overweight patients who also have other risk factors such as type-2 diabetes or dyslipidaemia (abnormal levels of fat in the blood).
Patients currently taking the drug are advised to make a routine appointment with their doctor at the next convenient time to discuss alternative measures for losing weight. People who wish to stop treatment before seeing their doctor can do so at any time as there are no health implications from doing so.
The suspension of a marketing authorisation is a precautionary measure, during which time a medicinal product is unavailable. More information on why Reductil has been suspended can be found on a Questions and Answers sheet released by the EMA.