Sibutramine (Meridia, Reductil)
A serotonin-norepinephrine reuptake inhibiting appetite suppressant. Approved in 1997 and withdrawn worldwide in 2010 following the cardiovascular results of the SCOUT trial. Today it matters chiefly as an undeclared adulterant.
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WHAT IS SIBUTRAMINE (MERIDIA, REDUCTIL)?
Detailed overview
Sibutramine is a serotonin-norepinephrine reuptake inhibitor marketed from 1997 as Meridia (US) and Reductil (Europe) for the treatment of obesity. The effect is real: by increasing satiety it produces measurable weight loss. The turning point was SCOUT (Sibutramine Cardiovascular OUTcomes), which followed 10,744 overweight patients at high cardiovascular risk. The trial was originally meant to demonstrate the cardiovascular benefit of weight loss. The result was the opposite: non-fatal myocardial infarction and non-fatal stroke were more frequent in the sibutramine arm than on placebo. The European Medicines Agency withdrew the drug in January 2010 and the FDA in October 2010. It is worth understanding precisely what SCOUT showed, because it is often misquoted. The 2012 analysis by Caterson found that SUSTAINED, intentional weight loss itself reduced cardiovascular events. The harm therefore did not come from losing weight but from the drug: from the blood-pressure and heart-rate consequences of its noradrenergic action, in a patient group whose hearts could no longer tolerate that. Today sibutramine's practical significance is not prescription use but the fact that it is the most frequently identified undeclared adulterant in "herbal" and "natural" slimming products worldwide. In that situation the user does not know they are taking it, and therefore has no chance of avoiding the contraindications and drug interactions. That is the main reason this page exists.
Mechanism
Serotonin and norepinephrine reuptake inhibition, increased satiety.
Why it was withdrawn
SCOUT (10,744 patients): more non-fatal myocardial infarction and stroke than placebo.
Date of withdrawal
EMA January 2010, FDA October 2010. No longer marketed anywhere as an approved drug.
Relevance today
The most common undeclared adulterant in "herbal" slimming products.
Half-life
Active metabolites ~14-16 h, hence once-daily dosing.
Data console
Lab data
Safety
Side effects, stop signs, contraindications
Side effects · 5
- Rising blood pressure and heart rate: a direct consequence of the noradrenergic action, and precisely what led to withdrawal of the approval.
- Increased cardiovascular events: in SCOUT, non-fatal myocardial infarction and stroke were more frequent than on placebo.
- Risk of serotonin syndrome: combined with an SSRI, SNRI, triptan or MAO inhibitor it can be life-threatening.
- Insomnia, dry mouth, constipation, anxiety and irritability: the most common, dose-dependent complaints.
- Undeclared presence in slimming products: users often do not know they are taking it, making interactions and cardiac risk impossible to guard against.
Contraindications · 5
- Any known cardiovascular disease: coronary disease, prior infarction or stroke, heart failure, arrhythmia. SCOUT demonstrated harm in exactly this population.
- Untreated or poorly controlled hypertension.
- Concurrent serotonergic medication (SSRI, SNRI, triptan, MAO inhibitor, tramadol): risk of serotonin syndrome.
- Pregnancy and breastfeeding, as well as hyperthyroidism and narrow-angle glaucoma.
- Competitive sport under testing: WADA bans stimulants in competition (S6).
Related Performance Compounds
Same therapeutic category
Studies
Related research and clinical findings
Maintained intentional weight loss reduces cardiovascular outcomes: results from the Sibutramine Cardiovascular OUTcomes (SCOUT) trial.
Caterson ID, Finer N, Coutinho W
Tolerability of sibutramine during a 6-week treatment period in high-risk patients with cardiovascular disease and/or diabetes: a preliminary analysis of the Sibutramine Cardiovascular Outcomes (SCOUT) Trial.
Maggioni AP, Caterson I, Coutinho W
Cardiovascular risk-benefit profile of sibutramine.
Scheen AJ
Tolerability and safety of the new anti-obesity medications.
Hainer V, Aldhoon-Hainerová I
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The information here is for educational and scientific purposes only. Performance-enhancing compounds (AAS, prohormones, stimulants, doping agents) are illegal without prescription in Hungary and most of the EU, and carry serious health and legal risks. WADA bans them in competitive sport. This is NOT a usage guide, and we do not encourage any illegal use. If you do use them, medical supervision and regular bloodwork are ESSENTIAL. Severe endocrine, cardiovascular, hepatic and psychiatric side effects are possible.