Brain Mind Center

Sibutramine (Meridia) Withdrawn Oct 2010

Meridia has been one of the most prescribed of recent weight loss drugs. We have expressed concerns about Meridia's efficacy and safety over the past 10 years and have advised against its use. Favorable pre-marketing studies showed modest weight loss benefits and the manufacturer claimed that sibutramine was a safe and effective drug. More objective data suggested that its modest benefits are not significant in light of potentially serious adverse effects.

Meridia was associated with death from cardiovascular causes. The drug was withdrawn first in Italy and was under scrutiny in other countries. The know effects of sibutramine include increases in blood pressure, heart rate and arrhythmias. This drug is similar to Prozac and was originally developed as an antidepressant. Its main action is to increase serotonin transmission in the brain by inhibiting the reuptake of the neurotransmitter. Increased serotonin activity in appetite regulating regions of the brain are associated with decreased appetite. Sibutramine taken with other antidepressants increased norepinephrine and serotonin levels. Its use was contraindicated in patients with cardiovascular disease. James et al reported as study of 10,744 overweight or obese subjects 55 years and older with preexisting cardiovascular conditions who were given long-term sibutramine treatment have an increased risk for nonfatal myocardial infarction and nonfatal stroke, but not cardiovascular death or all-cause mortality.

In October, 2010 the US FDA announced that Abbott Laboratories withdrew sibutramine (Meridia) from the market in light of clinical trial data pointing to an increased risk for stroke and myocardial infarction. The Sibutramine Cardiovascular Outcomes Trial (SCOUT), demonstrated a 16% increase in the risk for serious cardiovascular events such as nonfatal heart attack, nonfatal stroke, the need for resuscitation after the heart stopped, and death in a cohort of patients given sibutramine compared with another given a placebo.

Consider an objective evaluation of the drug published In 2001.

Sibutramine: slight weight loss. Prescrire Int 2001 Oct;10(55):140-5 (ISSN: 1167-7422)

(1) The reference treatment for achieving weight loss by obese patients is a combination of dietary measures, exercise and behavioural interventions. There is currently no drug treatment with demonstrated efficacy on the morbidity or mortality associated with excess body weight. (2) Sibutramine, a serotonin- and noradrenaline-reuptake inhibitor structurally related to the amphetamines has been granted marketing authorisation in France for the treatment of obesity and excess body weight in patients with associated risk factors. (3) The clinical file on sibutramine contains no trial focusing on morbidity or mortality end points. (4) According to comparative clinical trials, weight loss during a 6-12 month course of sibutramine is, on average, between 3 and 9 kg greater than that on placebo. Patients regain weight after sibutramine cessation. (5) Sibutramine has little or no benefit on blood sugar or lipid parameters. (6) The main known adverse effect of sibutramine is increased blood pressure. Sibutramine also has amphetamine-like side effects. (7) In practice, sibutramine currently has no place in the management of obesity.

See Eating and Weight Management


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