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Acomplia was withdrawn from the market in 2009 after the European Medicines Agency decided that the risk of side effects outweighed the potential benefits.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.

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The Crescendo trial was discontinued in November 2008 (after Acomplia was withdrawn from the prescribing list in the EU) as certain local health authorities were unhappy with suicide rates among those who were taking part in clinical trials.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

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.

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.

Exciting new research has been announced by the American College of Cardiology regarding the weight loss drug Taranabant. The study has shown that the new drug has a weight-loss result that is nearly as good as Acomplia (Rimonabant) but at one tenth of the dosage of its precursor in this new classification of drugs which target the endocannabinoid system. The study has also shown, however, that Taranabant has the same psychiatric side effects which stopped Acomplia from being licensed in the United States.

The producers of the drug, Merck, said that the two-year trial of Taranabant resulted in patients taking a 2mg dose losing an average of 14.5 pounds compared to a weight loss of 5.7 pounds for the patients that were placed on a placebo. While this result is extremely encouraging, it was also discovered that in the higher doses of 4mg and 6mg Taranabant had a higher incidence of psychiatric side effects than the 2mg dose. For this reason Merck has decided to continue its development of the drug focusing on the 2mg dose.

So how do the psychiatric side effects of a 2mg dose of Taranabant compare with a 20mg dose of Rimonabant? Well, so far, it is too early to make any real comparisons as the measuring and recording of these effects has recently been changed due to a more rigorous approval that has been introduced by the FDA (The American Food and Drug Administration.)

The incidence of psychiatric side effects of Taranabant was 28 percent at 2mg, 40 percent at 4mg and 38 percent at 6mg, though the severity of these side effects has not been released.

Merck has announced that it is to continue working to arrive at a point where Taranabant may be submitted to the FDA for approval as a drug that produces dramatic weight loss at the lowest possible dose.

Acomplia might be available on the NHS shortly as the drug has had a positive response from the National Institute for Health and Clinical Excellence.  The recommendation is that Acomplia should be available on the NHS for obese patients who are contraindicated for current treatments or have not responsed well to these other treatments.  Clearly this recommendation means that not everyone will be able to have this drug and there is no guarantee that doctors will be prepared to prescribe it - especially if the Primary Care Trusts do not make additional funding available.  Despite the increase in obesity in recent years, there is still a reluctance amongst some doctors and PCTs to use medication as part of the solution.

We will bring you more information on this subject as soon as we have any news so please don't rush to your GP just yet!

We have just heard that an advisory panel at the National Institute for Clinical Excellence is unlikely to recommend that Acompliashould be available free on the NHS.  Acomplia is a pretty expensive medication and it is not believed that value for money would be provided.  Acomplia will continue to be available on private prescription.

There is more news on Taranabant – the Merck competitor drug to Acomplia.  This drug is now nearing the end of its phase III clinical trials and we believe that results have been positive.  There have been reports of psychiatric side effects but this is not exactly surprising as Merck appears to have included patients with a history of depression and those currently being treated for depression. These categories of patients were deliberately excluded from the Acomplia trials.  As always, we will bring you more news on Taranabant as it comes in.

A few days ago we brought you news of a UK rival to Acomplia which is producing astounding results in Phase I clinical trials.  Well, now we can report that Taranabant, the Acomplia rival being developed by Merck, is entering the final stages of its Phase III clinical trial.  Around 2400 patients have been taking part in the international two year trial and the drug company expects to file for approval in Spring 2008.

Unlike the Acomplia clinical trials, we have not been constantly updated with news from the trials although we have heard on the grapevine that this drug could perform significantly better than Acomplia but this remains to be seen.

As soon as we have more details, we will be post another story.

A UK biopharmaceutical company has just announced results from a limited Phase 1 trial of a new CB-1 receptor antagonist which shows that the weight loss achieved compares very favourably with the results achieved by Acomplia (Rimonabant.)  The average weight loss over 16 days was 6 pounds for patients given a 5 mg dose.  Those who were administered a 100 mg dose lost 11 pounds on average over the 16 day period.  One patient actually lost 24 pounds which is a staggering amount in such a short period.

Vernalis (the company behind the new product) said that the results were achieved with “a markedly reduced propensity for neurological adverse events.”  It also demonstrated that fewer patients experienced nausea than similar trial results for Rimonabant.

This drug is in the very early days of testing so it will be years before it comes to the market for prescribing and it is not clear if these amazing results can be sustained over a longer period.  The good news is that both Pfizer and Merck have CB-1 receptor products which are much further advanced and we hope to be able to bring you some news on the progress of these trials very shortly.

The Indian regulatory authorities have approved Acomplia for prescription but they have also allowed the production of generic versions of the drug.  The generic versions of Acomplia are not legal in the EU, US or Canada so patients in these countries should avoid importing this medication from India as it is likely to be seized at customs.

There are a number of UK online medical sites which are prepared to prescribe Acomplia but you should be careful that you are getting the correct medication.  There are only a few sites which are actually prescribing the real thing.  A counterfeiting ring was recently exposed and there have been a number of arrests.

If you are unsure about the medication that you are being prescribed, you should ask the website in question to confirm the name and address of the pharmacy that will dispense your medication and you can then check this with the Royal Pharmaceutical Society of Great Britain.  We have a link on the Who We Are page of our website at online clinic which shows you how to do this via the RPSGB website.

Well, as we have been predicting here for weeks, Acomplia was not withdrawn from the European market when the European Medicines Agency’s Committee on Medicinal Products for Human Use reported earlier today.  Advice to doctors has changed very slightly relating to patients being treated for depression.  We have never prescribed Acomplia for any patient who was also being treated for depressions as we considered the risks of psychiatric side effects to be too great.  So as far as we are concerned, nothing has changed.  As always, if any of our patients develop depression while on Acomplia then they should contact us straight away and cease treatment immediately.

The European Medicines Agency’s Committee on Medicines for Human Use is meeting in London this week and amongst other matters, the committee will be deliberating over the post marketing safety data for Acomplia.  As we have announced in previous news items, the FDA in the US has not approved Acomplia for US consumers over concerns relating to adverse psychiatric events, including suicidal thoughts.

The post marketing data for European patients who have been treated with the medication include 208 adverse psychiatric events, including 27 of suicidal ideation.  In total, over 100,000 patients across Europe have been prescribed this medication.

The committee began its meeting on Monday 16^th July and it is expected to report on 19^th July.  Most analysts believe that Acomplia will not be withdrawn from the market in Europe but this still remains a possibility.  The expected outcome is that there will be a recommendation to include a stronger warning about the possible side effects. Anyone with a history of major depression should not take this medication as the risk of adverse psychiatric events is higher amongst this population.

The European Medicines Agency has announced that it is currently reviewing additional safety data on Acomplia and it will make an announcement on either 19^th or 20^th July regarding the future of Acomplia.  New data has been submitted which appears to suggest that Acomplia has brought on suicidal thoughts in some patients being treated with the medication.  Although we do not believe that Acomplia will be withdrawn from the market in Europe, this option cannot be ruled out.  We do not recommend this medication for anyone with a history of major depression and this is likely to be the formal recommendation of the panel at the European Medicines Agency.  Acomplia is currently only not recommended if someone is being treated for depression.

We will bring you more news on this item as soon as we have it.

Occasionally we get e-mails and telephone calls from people saying that our prices are expensive compared with another website that the customer has found.  When we examine the rival website, we can find no evidence that the medications offered are coming from a legitimate source so we warn the customers that the product is unlikely to be genuine given the price difference and the fact that the website does not seem to comply with regulatory guidelines.  Some take our advice and purchase from The Online Clinic and others, inevitably, decide to take their chances with the cheaper website. Invariably these people come back to The Online Clinic after a bad experience they have with the other website – either medication not being delivered or the medication having no discernible effect.

The regulatory authorities are getting tough with the counterfeiters and there are moves afoot to make their lives even more difficult in the future.  Just two weeks ago we heard about a large counterfeiting ring in Europe being smashed by the authorities in France.  The ring included a UK citizen who was involved in the counterfeiting of Acomplia – the popular weight loss medication.  The investigation was initiated by the public health department of the Paris public prosecutor’s office and led to simultaneous raids in five European countries: France; Sweden; Denmark; the Netherlands; and Romania.

The French investigators said that they uncovered an international traffic in counterfeit Acomplia which was produced in very unhygienic conditions and then sold over the internet to an unsuspecting public.

If you see websites selling medication for ridiculously cheap prices then you should be wary of doing business with them.  We have a policy of matching the prices offered by any regulated UK website.  Anything that looks suspicious, we will report to our regulator – the Medicines and Healthcare Regulatory Agency.

Acomplia was a ground-breaking new breed of medication which targeted the body’s little understood endocannabinoid system when it was launched in the UK last June but it could soon have one or more rivals. Both Merck and Pfizer have similar drugs in Phase III clinical trials which are said to be producing very promising results. Merck has already announced that it intends to apply for regulatory approval in 2008 and it is believed that Pfizer will be aiming to seek approval at around the same time. There is another drug which works in a similar way to Acomplia under development by Bristol Myers Squibb but it is believed that the development of this product is significantly behind those of Merck and Pfizer.

The drugs in development are all CB1 receptor antagonists. Results from the trials have not yet been published so it is not possible to gauge whether they will have a better success rate than Acomplia. What is known is that the slimming pill under development by Merck is going to be of a much lower dosage than the 20 mg at which Acomplia is licensed in the UK. The Phase II trial focused on 6mg, 4mg and 2 mg strengths but the Phase III trial will focus on 2mg, 1mg and 0.5mg, suggesting that the company has either concluded that a lower dose is better or the side effects were too severe at the higher dosages.

Although the endocannabinoid system is not fully understood, it is believed to form part of the body’s system of regulating cravings. Samples taken from obese women have been compared with samples taken from lean women and the level of endocannabinoids found to be much higher in the obese women. This discovery has led scientists to conclude that the endocannabinoid system is likely to be overactive in obese people. The introduction of Acomplia, which prevents the CB1 receptor from working, has helped thousands of obese patients in the UK to lose weight.