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Further to the announcement on our health blog on Friday that Acomplia was being withdrawn from sale in Europe, we thought that it would be appropriate to give readers a bit more information behind this development.

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.

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 Acomplia should 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.

Yet again we have some news on Acomplia from another part of the world and yet another clinical trial.  A study of 526 obese patients in Japan showed that Acomplia had a dramatic effect on the reduction of the dangerous visceral fat which surrounds certain organs such as the liver.  The study showed that those taking the normal 20 mg a day dose managed a reduction in visceral fat twice that of those on the placebo.

The visceral fat contains large insulin resistant fat cells which can lead to type 2 diabetes and heart disease.

In a separate announcement, Sanofi Aventis has said that it will not seek approval for Acomplia in the US for use in obese patients for around 3-4 years.  This will be a huge disappointment to many overweight Americans, many of whom contact us on a daily basis looking for Acomplia.  Unfortunately, owing to regulatory restrictions, we cannot prescribe medication to American residents.

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.

New information on Acomplia has come to light that may explain why the FDA committee was reluctant to recommend it for approval in the USA.  Acomplia underwent a two year study which resulted in patients losing 10% of their body weight after 12 months of treatment.  Those patients who continued with Acomplia for a further 12 months managed to maintain the weight loss that they had achieved but another group, which was switched to a placebo, quickly regained the weight that they had lost.  If Acomplia requires to be taken for longer than two years, there simply is not enough safety data to determine whether or not this is advisable.  At the moment Acomplia is only licensed by the European Medicines Agency for use up to a maximum of two years.

This latest development seems to contradict previous findings which suggested that Acomplia could help obese patients keep the weight off even after they had ceased treatment.  There are other medications in the same class as Acomplia. i.e. CB1 receptor antagonists and we await the results of clinical trials to see if these are more or less effective than Acomplia.

Having said all this, we have quite a high number of patients who have used Acomplia and it has worked better for them than anything else that they have tried, especially in getting rid of the weight carried around the middle.  The key to keeping the weight off long term is to maintain the healthy lifestyle adopted while on the medication.

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.

Acomplia could have some new safety data published as early as today in response to new information relating to potential side effects.  It is highly unlikely that the European Medicines Agency will withdraw the drug’s licence but it is likely to issue new warnings over the risks of depression and the potential for suicidal thoughts.  We have not had any reports of patients feeling suicidal but as we have said in previous news stories, a few patients have suffered from depression.

As soon as we have any new information, we will publish the information here.

A few days ago it was announced that Acomplia will not be approved by the FDA for prescription in the United States.  Apparently the advisory committee which reports to the FDA received information concerning the safety of Acomplia which influenced its unanimous decision not to recommend the treatment.

The European Medicines Agency’s Committee for Medicinal Products for Human Use will meet this week and it is most likely that Acomplia will be on the agenda for discussion.  We believe that it is highly unlikely that the EMA will decide to withdraw Acomplia from the market in Europe but there may be a change to labelling, giving greater prominence to the possible psychiatric side effects:  It has been suggested that patients taking Acomplia have had suicidal thoughts and this was one of the factors which influenced the FDA committee.

We have written thousands of prescriptions for Acomplia since it was launched almost a year ago and we obviously review each patient’s experiences.  It has to be said that most people seem to be taking this medication without any side effects whatsoever.  A few people have mentioned that they have a feeling of nausea for a few hours after they take the medication and some have noticed mood swings.  We have had to take two patients off the medication because they were suffering what we thought was likely to be depression and one woman admitted herself to hospital after suffering a very unfortunate conglomeration of recognised side effects.  This was obviously an extreme example of what can happen but it was terrifying for the patient involved.

Those who have suffered side effects such as depression seem to get back to normal within around two weeks of ceasing treatment.  If you have any stories of your experience with Acomplia, we would like to hear about them.

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.