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by Robert MacKay, Wednesday, 24 August 2011 | Categories: Acomplia

A group of people who were prescribed Acomplia by their doctor have decided to sue the manufacturer because of the side effects that they suffered.

Acomplia was withdrawn from the market in 2009 after the European Medicines Agency decided that the risk of side effects outweighed the potential benefits. Many people who were prescribed the medication suffered psychiatric side effects with at least one suicide recorded in the UK that was linked to Acomplia. Other than suicidal ideation, a number of people suffered changes in their personality that persisted for a few weeks after they stopped taking Acomplia.

The Online Clinic prescribed Acomplia to a number of patients but we only had one who suffered any form of psychiatric side effect and we are happy to say that she made a full recovery. It is alleged that people who had never suffered from depression before got depressed after taking Acomplia. As a precaution, The Online Clinic refused to prescribe Acomplia to patients who had any history of depression – even post-natal depression – and we think that this is one of the contributory factors in us having such a low incidence of side effects given the many thousands of patients for whom we prescribed the medication.

The manufacturer of Acomplia has refused to settle this matter out of court.

by Robert MacKay, Thursday, 19 August 2010 | Categories: Acomplia

This week’s issue of The Lancet writes an account of the termination of the CRESCENDO trial of Rimonabant, formerly marketed as Acomplia. The Crescendo study by, Eric J. Topol, of Scripps Translational Science Institute, assessed whether Rimonabant (a previously approved weight loss medication) improved cardiovascular risk.

Covering 42 countries and 18,695 patients, the group was split in two with half chosen to take 20mg of Rimonabant while the other half were chosen to take a placebo. Rimonabant’s function is to block the cannabinoid 1 receptors – part of the body’s not very well understood endocannabinoid system. These CB1 receptors have a role to play in appetite. By blocking the CB1 receptors, appetite is suppressed and ultimately, weight is lost. Rimonabant has also been said to maintain good glucose levels and it has been shown to have a positive effect on cholesterol levels too.

The Crescendo trial was discontinued in November 2008 (after Acomplia was withdrawn from the prescribing list in the EU) as certain local health authorities were unhappy with suicide rates among those who were taking part in clinical trials.  In the Crescendo trial there were 4 suicides from those taking the Rimonabant and 1 taking the placebo.

The number taking Rimonabant and died as a result of a cardiac illness, myocardial infarction or stroke was equal to the number of fatalities among those who were being treated with the placebo. However, there was a marked effect on neuropsychiatric processes, serious psychiatric effects and gastrointestinal problems associated with the taking of Rimonabant. Contrasting the effects with those of the placebo, Rimonabant caused substantially more instances.

To avoid these harmful effects at trial stage in the future, it has been suggested that genomics might be used to test such controversial drugs. S. Matthijs Boekholdt and Ron J. G. Peters, Academic Medical Centre, Amsterdam, said that if the trial had not been suspended, a massive improvement could have been made to revolutionise cardiovascular health and with only a small risk of serious effects accompanying it. It is this small risk which impeded completion of the trials but any preventative treatment for cardiovascular risk which can result in fatality, say Boekholdt and Peters, is deemed unacceptable.

by Robert MacKay, Friday, 30 July 2010 | Categories: Acomplia | Diet Pills

An exciting time for Denmark based drug company 7TM Pharma, as they complete the first stage of clinical trials for the as yet unnamed drug molecule, TM38837. Likened to effective weight loss drugs of the past such as Acomplia, the drug will perform similarly but without the side effects once associated with other drugs from the same family.

TM38837 functions as a CB1 receptor blocker. This drug blocks the cannabinoid receptors which are responsible for the feeling of hunger. Such antagonists work directly on the central nervous system and in the past have been criticised for their harmful, psychological effects. Although blocking the same receptors as Acomplia once did, TM38837 does so without crossing the blood-brain barrier to any significant degree and instead concentrates on blocking receptors in the peripheral nervous system. This action is likely to eliminate the psychiatric side effects associated with Acomplia.

Rigorous clinical trials are being carried out and so far the results have been successful and out of 48 healthy adults tested, only 7 experienced mild side effects with a majority responding well. It will be this Autumn before the results of the next stage of clinical trials are available. If the trials are successful, this will finally be a major advancement for weight loss drugs.

by Robert MacKay, Monday, 27 October 2008 | Categories: Acomplia

Further to the announcement on our health blog on Friday that Acomplia was being withdrawn from sale in Europe, we thought that it would be appropriate to give readers a bit more information behind this development.

When it was launched in 2006 Acomplia was hailed as a wonder drug. The clinical trials had shown that forty per cent of those who were given the drug lost up to ten per cent of their total body weight. Now just two years later, the European Medicines Agency has suspended Acomplia’s licence after linking the drug to depression, psychosis and suicidal tendencies. The EMA said in a statement that they did not believe that the positive attributes of the drug outweighed by the potential side effects.

Around 2500 adverse reactions to the drug have been reported in the UK since Acomplia became available for private prescription two years ago. Perhaps surprisingly, Acomplia was cleared by the National Institute for Clinical Excellence (NICE) to be prescribed on the NHS only four months ago, though it was only to be made available for patients who were regarded as having tried every other available method of losing weight.

The possible side effects of the drug were well known and there were clear warnings on the packets that detailed the risk of depression, anxiety and other serious psychiatric side effects from taking the medication.

The EMA said that Acomplia had proved less effective in ‘real life’ than in its clinical trials. The fact that one in ten users of the drug were reporting mental health side effects led them to conclude that Acomplia was not a viable weight loss medication. This is obviously a big blow for people who are taking Acomplia and who are losing weight without any adverse side effects.

As one door closes, however, another one opens and it was announced this week that another weight loss drug called tesofensine was in advanced clinical trials and was ‘twice as effective’ as anything currently available. Only time will tell.....

by Robert MacKay, Friday, 24 October 2008 | Categories: Acomplia

Acomplia has had its European licence suspended with effect from today.  The Online Clinic will no longer be issuing anymore prescriptions for Acomplia as from today.  We will keep you updated with events as we understand that the manufacturer will be making representations to the European Medicines Agency.

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