Reductil marketing authorisation suspended

on the 28 January 2010

The Committee for Medicinal Products for Human Use (CHMP) has recommended that the marketing authorisation for Reductil (sibutramine) is suspended across Europe following a review completed by the European Medicines Agency (EMEA), which found that the risks outweighed the benefits.

Prescribers are advised by the MHRA not to issue any new prescriptions for sibutramine (Photograph: DR P. MARAZZI/SPL)

The recommendation follows new safety information from a large
clinical trial, the Sibutramine (Reductil) Cardiovascular OUTcomes (SCOUT) study.

Healthcare professionals had been advised to regularly monitor all patients taking sibutramine, since its launch in 2001, for increases in blood pressure and heart rate. The SCOUT study was carried out at the request of the CHMP, due to cardiovascular safety concerns, to determine the effects of sibutramine in obese and overweight patients with cardiovascular risks.

SCOUT was a randomised, double-blind placebo-controlled study in approximately 10,000 obese and overweight patients with cardiovascular disease and/or type 2 diabetes over a six-year period.

The results demonstrated a 16% increased risk of cardiovascular events such as MI and stroke when compared to placebo. Sibutramine achieved only a modest mean weight loss of approximately 2—4kg more than placebo.

Key recommendations:

Prescribers should not issue any new prescriptions for Reductil and should review the treatment of all patients currently taking the medicine.
Pharmacists should not dispense any prescriptions for it and advise patients to make an appointment to see their doctor.
Those currently treated with sibutramine should schedule an appointment with their doctor at the next convenient time. Patients may stop treatment before their appointment if they wish.