Medicines regulatory agencies in both Europe and the US have announced that they are re-examining the benefit to safety ratio for medicines containing sibutramine (Reductil® etc.). This follows the provision by the drug’s manufacturer of preliminary safety results from the Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event (SCOUT) trial.

The SCOUT study specifically recruited subjects with a high risk of cardiovascular disease, and the preliminary analysis suggests that patients in the sibutramine group had more serious cardiovascular events than those in the placebo group (11.4% vs. 10%).

Both agencies are analysing the new data, and will recommend any further action once they have assessed its impact on the drug’s risk to benefit balance.

The FDA notes that current US prescribing information includes recommendations that the drug should not be used in patients with serious cardiovascular disease; it is also contra-indicated in such patients in the EU licence.