Sibutramine

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The European Medicines Agency has completed a review of the safety and effectiveness of sibutramine. The Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of sibutramine do not outweigh its risks, and that all marketing authorisations for medicines containing sibutramine should be suspended throughout Europe.

The European Commission issued a decision on 6 August 2010.

What is sibutramine?

Sibutramine is a ‘serotonin-noradrenaline re-uptake inhibitor’ (SNRI). It works by preventing the neurotransmitters 5-hydroxytryptamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain. Neurotransmitters are chemicals that allow nerve cells to communicate with one another. By blocking their re-uptake, sibutramine increases the amount of these neurotransmitters in the brain.

Sibutramine-containing medicines are used in the management of obesity. The increased levels of neurotransmitters in the brain help patients to feel full after a meal, and this helps to reduce their food intake. They are used, alongside diet and exercise, in patients who are obese (very overweight) with a body mass index (BMI) greater than or equal to 30 kg/m², and in patients who are overweight (with a BMI greater than or equal to 27 kg/m²) and also have other obesity-related risk factors, such as type 2 diabetes or dyslipidaemia (abnormal levels of fat in the blood).

Sibutramine-containing medicines have been authorised in the European Union (EU) since 1999. They are available as capsules containing 10 mg or 15 mg sibutramine, under the trade names Reductil and other names1, and as generic medicines.


1 Afibon, Ectiva, Lindaxa, Meissa, Meridia, Minimacin, Minimectil, Obesan, Sibutral, Sibutril, Siluton, Sitrane, Redoxade, Zelixa and Zelium.

Why was sibutramine reviewed?

Sibutramine was originally reviewed by the Agency in 1999 and 2002, following concerns over its safety, especially cardiovascular side effects (increased blood pressure and heart rate). At that time, the CHMP concluded that the benefits of sibutramine for the management of obese and overweight patient outweighed its risks. However, the Committee also asked the company that makes Reductil, Abbott Laboratories, to start a study of sibutramine in patients with cardiovascular risk factors, looking particularly at the medicine’s safety. The Committee also asked the company to provide six-monthly updates on the progress of the study.

As a result, in 2002, the company started the SCOUT study (Sibutramine Cardiovascular Outcome Trial) to determine the impact of weight loss with sibutramine on cardiovascular problems in a large group of overweight and obese patients at high risk for cardiovascular disease. The study compared sibutramine with placebo (a dummy treatment), and looked not only at how much weight the patients were losing, but also at the occurrence of cardiovascular events, such as heart attack, stroke and cardiac arrest. In total, about 9,800 patients have been followed up for six years.

Although the full data from the SCOUT study have not yet been analysed, the study’s Data Safety Monitoring Board (a body of independent experts appointed to review regularly the outcome of the clinical trial) informed the Agency in October 2009 of preliminary data indicating that sibutramine is associated with more cardiovascular problems than placebo.

On the basis of these data, the German medicines regulatory agency (BfArM) triggered in November 2009 a review under Article 107 of Directive 2001/83/EC. They requested that the CHMP assess the impact of the new data on the benefit-risk balance of sibutramine to prepare an opinion on whether the marketing authorisations for products containing sibutramine should be maintained, changed, suspended or withdrawn across the EU.

Which data has the CHMP reviewed?

The CHMP reviewed the responses from the company to a list of questions on the SCOUT study. The Committee also looked at other studies on the effectiveness of sibutramine for weight loss.

The Committee also consulted a group of experts specialising in the treatment of metabolic diseases.

What are the conclusions of the CHMP?

The CHMP noted that the SCOUT study showed an increased risk of serious cardiovascular events (such as heart attack or stroke) in patients with known cardiovascular disease taking sibutramine.

Most of the patients in the SCOUT study would not normally be given sibutramine, as the medicine is contra-indicated in patients with cardiovascular disease. Nevertheless the Committed considered that an increased risk can also apply to patients for whom sibutramine can be prescribed because obese and overweight patients are likely to be at risk of cardiovascular disease.

Finally, looking at all of the studies of sibutramine in the management of obesity, the CHMP noted that the weight loss achieved with sibutramine treatment is modest in comparison with that obtained with placebo, with patients losing on average two to four kilograms more than with placebo. The Committee also noted that it is not clear if this effect on weight loss can be maintained when sibutramine treatment is stopped.

Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of sibutramine-containing medicines do not outweigh their risks, and therefore recommended that the marketing authorisations for sibutramine-containing medicines be suspended across the EU. The suspension will remain in place until the company can provide data that are sufficient to allow the identification of a group of patients for whom sibutramine’s benefits clearly outweigh its risks.

What are the recommendations for prescribers and patients?
  • Doctors should stop prescribing sibutramine-containing medicines to obese or overweight patients. They should also review the treatment of patients currently treated with the medicine.
  • Pharmacist should no longer dispense sibutramine-containing medicines.
  • Patients who are taking a medicine containing sibutramine to help them to lose weight should make an appointment with their doctor at the next convenient time to discuss alternative measures to lose weight. Patients who wish to stop treatment before seeing their doctor can do so at any time.
  • Patients who have any questions should speak to their doctor or pharmacist.
Name Language First published Last updated
Questions and answers on the suspension of medicines containing sibutramine BG = bălgarski 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine ES = español 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine CS = čeština 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine DA = dansk 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine DE = Deutsch 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine ET = eesti keel 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine EL = elliniká 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine EN = English 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine FR = français 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine IT = italiano 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine LV = latviešu valoda 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine LT = lietuvių kalba 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine HU = magyar 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine MT = Malti 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine NL = Nederlands 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine PL = polski 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine PT = português 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine RO = română 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine SK = slovenčina 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine SL = slovenščina 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine FI = suomi 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine SV = svenska 2010-01-21 2010-09-15

Key facts

Approved nameSibutramine
International non-proprietary name (INN) or common name

sibutramine

Associated names-
Class-
Reference numberEMA/808179/2009, EMA/H/A-107/1256
TypeArticle 107 procedures (prior to July 2012)

This type of procedure was triggered when a Member State varied, suspended or revoked the marketing authorisation for a medicine in its territory because of a safety issue. This procedure is no longer applicable and has been replaced by Article 107i.

StatusEuropean Commission final decision
Opinion date21/01/2010

All documents

Name Language First published Last updated
Questions and answers on the suspension of medicines containing sibutramine BG = bălgarski 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine ES = español 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine CS = čeština 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine DA = dansk 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine DE = Deutsch 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine ET = eesti keel 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine EL = elliniká 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine EN = English 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine FR = français 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine IT = italiano 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine LV = latviešu valoda 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine LT = lietuvių kalba 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine HU = magyar 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine MT = Malti 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine NL = Nederlands 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine PL = polski 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine PT = português 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine RO = română 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine SK = slovenčina 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine SL = slovenščina 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine FI = suomi 2010-01-21 2010-09-15
Questions and answers on the suspension of medicines containing sibutramine SV = svenska 2010-01-21 2010-09-15
Sibutramine - Article 107 procedure - Annex I, II, III BG = bălgarski 2010-09-15  
Sibutramine - Article 107 procedure - Annex I, II, III ES = español 2010-09-15  
Sibutramine - Article 107 procedure - Annex I, II, III CS = čeština 2010-09-15  
Sibutramine - Article 107 procedure - Annex I, II, III DA = dansk 2010-09-15  
Sibutramine - Article 107 procedure - Annex I, II, III DE = Deutsch 2010-09-15  
Sibutramine - Article 107 procedure - Annex I, II, III ET = eesti keel 2010-09-15  
Sibutramine - Article 107 procedure - Annex I, II, III EL = elliniká 2010-09-15  
Sibutramine - Article 107 procedure - Annex I, II, III EN = English 2010-09-15  
Sibutramine - Article 107 procedure - Annex I, II, III FR = français 2010-09-15  
Sibutramine - Article 107 procedure - Annex I, II, III IT = italiano 2010-09-15  
Sibutramine - Article 107 procedure - Annex I, II, III LV = latviešu valoda 2010-09-15  
Sibutramine - Article 107 procedure - Annex I, II, III LT = lietuvių kalba 2010-09-15  
Sibutramine - Article 107 procedure - Annex I, II, III HU = magyar 2010-09-15  
Sibutramine - Article 107 procedure - Annex I, II, III MT = Malti 2010-09-15  
Sibutramine - Article 107 procedure - Annex I, II, III NL = Nederlands 2010-09-15  
Sibutramine - Article 107 procedure - Annex I, II, III PL = polski 2010-09-15  
Sibutramine - Article 107 procedure - Annex I, II, III PT = português 2010-09-15  
Sibutramine - Article 107 procedure - Annex I, II, III RO = română 2010-09-15  
Sibutramine - Article 107 procedure - Annex I, II, III SK = slovenčina 2010-09-15  
Sibutramine - Article 107 procedure - Annex I, II, III SL = slovenščina 2010-09-15  
Sibutramine - Article 107 procedure - Annex I, II, III FI = suomi 2010-09-15  
Sibutramine - Article 107 procedure - Annex I, II, III SV = svenska 2010-09-15  

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes have been recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

Current status:
European Commission final decision

More information on sibutramine