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Update on Accomplia (Rimonabant)

• Introduction
• Why the concern over Accomplia?
• What’s changed with Accomplia?
• Tell me more about the data available
• Why has the EMEA recommended suspension of this drug?
• I am currently taking Accomplia - what should I do?
• What are the symptoms of depression?
• Should I stop taking Accomplia immediately?

Introduction

On the 23rd of October 2008 the European Medicines Agency (EMEA) called for the suspension of the marketing authorisation for the drug Accomplia or Rimonabant. Accomplia is a drug which promotes weight loss and is currently licensed in the UK.

Why the concern over Accomplia?

The initial prescribing licence for Accomplia carried warnings about the possibility of psychiatric side effects such as depression.

What’s changed with Accomplia?

It is now considered that the risk of developing psychiatric disorders is approximately double that of those taking placebo. The term placebo refers to ‘dummy pills’ which are used in pharmaceutical trials to compare the effects of medications.

The EMEA committee also commented that the effectiveness of Accomplia in clinical practice is more limited than was expected form studying the initial data.

Tell me more about the data available

A number of serious psychiatric problems have been reported among patients taking Accomplia or Rimonabant. These effects include depression, anxiety and panic attacks. Of a total of 36,000 patients taking the drug, five cases of severe depression leading to suicide have been reported.

Why has the EMEA recommended suspension of this drug?

The Medicines Agency has recommended withdrawal of this product as they consider the benefits of taking the drug no longer outweigh the risks.

I am currently taking Accomplia - what should I do?

If you are currently receiving treatment with Accomplia you should contact your doctor to discuss whether you should continue therapy. This is especially important if you have any symptoms of depression or anxiety. If you are currently receiving anti depressant medication you definitely should not continue to take Rimonabant.

What are the symptoms of depression?

Depression is characterised by symptoms of low mood, low self esteem, low energy levels and sleep disturbances. More information is contained within a separate page on this website.

Should I stop taking Accomplia immediately?

You do not need to stop taking this drug right now. You may stop if you wish to do so. It is best that you discuss this with your doctor.

 

24th October 2008
Dr Nishan Wijenaike MD, FRCP
Consultant Physician