Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Rimonabant licence to be suspended

The European Medicines Agency (EMEA) has recommended that the product licence for rimonabant (Acomplia®) is suspended. This announcement has reached the general media (BBC).

The Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of rimonabant no longer outweigh its risks and the marketing authorisation should be suspended across the European Union (EU). This decision has been reached because post-marketing experience indicates that serious psychiatric disorders may be more common than in the clinical trials

The Medicines and Healthcare products Regulatory Agency have written to healthcare professionals (PDF) with the following advice:

  • Prescribers should not issue any prescriptions for rimonabant, and should review the treatment of those who are currently taking this medicine
  • Patients who are currently taking rimonabant should consult their doctor or pharmacist at a convenient time to discuss their treatment. If patients wish to stop taking rimonabant, it is safe to do so at any time
  • Patients who are currently enrolled in clinical trials of rimonabant may wish to contact the trial investigator (the doctor who is treating them), who will be able to give more information. Trial investigators are being notified of this suspension of the marketing authorisation

Action: Clinicians should be aware of the licence suspension. No new prescriptions should be issued and patients currently using this medication should be advised to return it to a pharmacy for destruction.

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5 Comments to “Rimonabant licence to be suspended”

  1. Sue,

    I don't know you and you don't know me so I don't think we should start getting personal.

    I must have misunderstood you when you said "experts should consider how many people that are fat are happy". I believe that there are "fat" people who are happy with who they are and the way they look and I thought you were suggesting we should leave them alone - a point with which I could not agree more.

    If I understand your latest comment correctly you are questioning the removal of the drug from the market compared to the suicide rate of Wales. I understand that the Welsh Assembly are taking steps to tackle the issue in Wales. But the excessive rate of suicides in Wales does not lessen the harm that this drug has the potential to cause. This drug was causing more than just suicides, in fact only 1 successful suicide has been reported in the UK. This pales into insignificance when you look at in excess of 1,000 reports of psychiatric disorders reported in 3 and a half years.

    Comment by Matthew Robinson — November 7, 2008 #
    Reply

  2. oh my word Matthew you must be a doctor and a thin one at that!
    Clearly from the sanctimonious tone of your comment you are unable to appreciate my point ... 330 people (as opposed to the few that committed suicide on Rimonobant, which was know during trials before NICE agreed its use) died in Wales last year as a result of suicide... how can this be allowed to continue?
    I did not say people are fat and happy indeed the total opposite! I don't know any one that is fat and happy. Doctors and the general public see fat as ugly and self inflicted and do nothing to help until it is too late. Why do people have eating disorders? it always is a suprise to me that if I was anorexic,sympathy & treatment would be readily available. The opposite end of the scale and one is told to do more and eat less!
    and the 'some people' you refer too are 5 short of one million world wide.... Much more chance of committing suicide if you live in Wales. Do you also think 'this should not be something that can continue'?

    Comment by Sue Thompson — November 7, 2008 #
    Reply

  3. Sue,

    Every time a drug is withdrawn from the market there are many comments made by people for whom the drug worked and worked well.

    None of this ever changes the fact that the drug was withdrawn for safety reasons. As you say many people are 'fat and happy'. This drug helped some people get slim but also killed others in the process. Clearly that is not something that can be allowed to continue.

    Comment by Matthew Robinson — November 7, 2008 #
    Reply

  4. As a patient who has taken Rimonabant for 14 months I am appalled that this medication has been withdrawn.

    Following RAI for an overactive thyroid I became underactive putting on some 44 pounds in three months. I struggled for 18 months to get rid of the excess weight without success...please spare me your thoughts ( and comments) about do more and eat less! been there and done all that so to speak! Then after being prescribed this drug I have lost all of the weight and feel like I have a life again. what now? I certainly never gave suicide a thought whilst taking the drug....the so called experts should consider how many people that are fat are happy which may be of more importance than satistics.... which given the ones from Wales (330 suicides in a year)should generate a mass evacuation from the country.

    Comment by Sue Thompson — November 7, 2008 #
    Reply

  5. [...] withdrawal of this guidance is as a result of suspension of the marketing authorisation for rimonabant (Acomplia®) by the European Medicines Agency [...]

    Pingback by Prescribing Advice For GPs » NICE Rimonabant Advice Withdrawn — October 30, 2008 #
    Reply

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