Roche, the manufacturer of Xenical, has announced that it anticipates a shortage of stock of 120mg Orlistat capsules and the shortage is predicted to last a number of weeks. The company has been experiencing manufacturing issues and these may take a little while to be resolved and for stock levels in the UK to be replenished. Generic versions of orlistat manufactured by Teva may be available although there are stock shortages on this item as well. If the generic stock does become available, patients are advised to continue with this therapy until brand Xenical becomes available again. It is important that patients continue to obtain their prescriptions through the legitimate supply network.

Patients will be notified through their patient record when we are out of Xenical stock.

Xenical is currently the only licensed drug for weight loss in the EU so it is frustrating to hear rumours about its potential association with kidney problems. Canadian research has tentatively suggested that there is a link between Xenical (Orlistat) and kidney problems and their findings are published in the Archives of Internal Medicine.

953 new Orlistat users were monitored and they found that 0.5% of new users were admitted to hospital for kidney problems in the year prior to taking the drug. The following year this number jumped to 2%. There is little evidence to suggest that Xenical is itself a cause of kidney disease and it has not been listed as a side effect. A few users presented with kidney problems at trial stage but not in numbers significant enough to suggest that Xenical was the root cause.

Orlistat is available over the counter in the UK and US as Alli and there have been serious suggestions that this is not appropriate. The latest research does underline why it is important for medicines to be prescribed by a doctor and the patient’s progress properly monitored. If patients purchase treatment over the counter and they are not subsequently monitored, side effects that may appear inconsequential to the patient may go without note but would cause alarm bells to ring with a doctor. The Online Clinic prescribes Xenical online but we require all patients to complete regular reports to that their progress can be monitored.

The American drug regulators, the FDA, have announced that packs of orlistat (the active ingredient in Alli and Xenical) must now carry warnings about the possibility of liver problems.

The move comes after a long-running investigation into 12 reports between 1999 and 2007 of people suffering liver damage. All 12 were living outside of the US, though there was one report of a US citizen suffering from liver problems.

When compared with the number of people taking the medication worldwide, the potential side-effect is extremely rare. Both Roche, who manufacture Xenical, and Alli manufacturers GlaxoSmithKline pointed out that the number of reported problems was extremely small.

The patient information leaflet for both medications now warns that patients should be aware of the symptoms of liver damage, which include itching, yellow eyes, lighter-coloured stools, dark urine and loss of appetite.

Previously the manufacturers had warned that obese patients are more prone to developing liver problems.

UK packaging already contains a warning about liver damage so the ruling will not make a difference to UK patients.

GlaxoSmithKline’s chief medical officer Howard Marsh said that the company wanted people to ‘have the information they need to choose the right weight loss aid for their situation’.

Figures released yesterday have shown that Scottish doctors are writing increasing numbers of prescriptions for anti-smoking medications.

There has been a 31% increase in the number of smokers taking drugs to try to kick the habit over the past year, according to the statistics issued by the Information Services Division Scotland.  It has been suggested that the increase is due to the launch of a new service where local pharmacies can offer access to stop smoking treatments.

The Public Health Minister for Scotland, Shona Robison, said that smoking was the biggest preventable cause of death in Scotland and was responsible for over 13,500 deaths each year. She said that the increase in prescriptions being written showed that increasing numbers of people were seeking support to give up cigarettes.

Data also showed there has been an increase in the number of prescriptions being written for slimming tablets, mainly the fat-blocker Xenical (Orlistat). There was a 3% rise from the previous year, increasing by 3,041 prescriptions to 113,365. 78,000 of those prescriptions were for Xenical.

Ms. Robinson said that the decision to prescribe slimming pills or not is ‘between a doctor and their patients’ but added that the Scottish government had introduced a number of measures to improve health in Scotland, tackle obesity and encourage more exercise.

The Chairman of the National Obesity Forum has issued a strong criticism of the recent decision of the European Medicines Agency to suspend Reductil (sibutramine) in the European Union. Dr David Haslam described the recent decision as “preposterous, totally naive and unscientific.” This view accords with many others in the medical community who are astounded by the decision to ban Sibutramine based on the effects that it has on patients who are not supposed to be prescribed the drug in the first place!

With Reductil now suspended, the only alternative weight loss product offered for prescription in the whole EU is Orlistat in the form of Xenical. Orlistat is also available over the counter in pharmacies at a lower dose under the brand name Alli. Alli saw massive sales when the medication was launched in the US and the EU but disappointing results from the treatment have led to low levels of repeat orders. Xenical appears to be fairing slightly better as the dosage is higher but many people find the weight loss to be too slow for them. What must be remembered is that a slow and steady loss of weight is the best way to proceed as this is more likely to be sustained once the medication is discontinued so long as the patients maintain a healthy diet and regular exercise.

The decision of the European Medicines Agency is continuing to look even more bizarre as equivalent licensing authorities around the world react to the recent clinical trials in a much more cautious way by enhancing the warning labels. The Malaysian Health Authority was the latest licensing agency to say that they thought that the EU decision went too far without further scientific data.

Danish researchers believe that they have developed a new ‘diet injection’ which as well as being much more effective than current slimming pills on the market could also project against type II diabetes.

Patient were injected with liraglutide to combat diabetes but the results from the trials indicated that the drug makes patients twice as likely to lose weight as those who are taking orlistat, or Xenical.

Published in the journal the Lancet the results showed that the drug curbed hunger pangs as well as reducing risk factors for diabetes. However while  Xenical is in pill form, making it convenient to take, liraglutide needs to be injected daily as in pill form it would be broken down by the gut. It is also an expensive drug, costing £500 for six months of treatment.

In the trial, lead by a paid consultant of the pharmaceutical firm manufacturing the drug Professor Arne Astrup, three groups of patients in 19 hospitals were put on a diet which reduced their calorie content by 500 calories a day and told to exercise. One group were given orlistat, one group given liraglutide, and one group given a placebo.

Professor Astrup said that the drug mimics the action of a hormone found in the gut, GLP-1, which is released into the body after someone has eaten. It then tells the body to produce more insulin and acts as a satiety hormone, telling the brain to stop eating.

Over 20 weeks, over 3/4s of those given the injections lost more than 5% of their body weight, weight loss experienced by 44% of those taking orlistat and 30% of those taking the placebo.

Further tests are planned as the trial ran for a relatively short period, and the researchers need to establish the longer term ratio between risks and benefit. Health charity Weight Concern have said that while the development of good weight loss drugs is important, emphasis still needs to be on supporting people in changing their lifestyle and diet. Dr. George Bray from Louisana State University, who wrote the accompanying editorial in the Lancet,  said that it was not yet clear whether an injection would prove a “palatable” means of delivering weight loss medication but said he was optimistic that the potential of the new generation of weight loss medications would be fulfilled.

The US and China are locked in a battle over the custody of a Chinese woman accused of importing illegal medication, including the diet pills Reductil and Xenical and erectile dysfunction medications like Viagra and Cialis.

Miao Qun Huang, also known as Cherry Wong, has been investigated by U.S officials for illegal trade of counterfeit medications, and the National Bureau of Investigation has placed her on ‘provisional arrest’ to be extradited to from the Philippines to Texas. The provisional warrant was issued by a Manila court.

However the Chinese embassy in a diplomatic note sent to the Department of Justice said that as she was a Chinese national holding a Chinese passport, and her crimes were committed in the Chinese mainland, they believed that China had jurisdiction over her.  They added that China was strongly opposed to her extradition to any third country without their prior consent.

If she is successfully extradited to Texas, Huang will face 7 charges of trafficking counterfeit Viagra, Cialis, Xenical and Reductil. Her lawyer is arguing that as the Philippines and China signed their own extradition treaty preventing the extradition of a country’s citizen without the consent of their country of nationality, she cannot be sent to Texas to face trial.

Her lawyer Jose Bernas has said that her extradition would set a dangerous precedent in international law, warning that it could leave the Philippines open to the extradition of their own nationals, either from the Philippines or a third country, for crimes committed outside of the requesting state’s territory.

After the UK Medicines and Healthcare Regulatory Agency announced  that it would not be taking legal action over the marketing of its slimming drug Xenical, Roche pharmaceuticals is potentially facing a case brought by the European Commission.

The potential law suit relates to sanctions that were imposed on Roche last year by the pharmaceutical industry’s trade body after they were discovered to be using aggressive sales tactics in private clinics.

The Prescription Medicines Code of Practice Authority, which sees itself as the self-regulatory authority of the pharmaceutical industry in Britain, last year suspended Roche’s membership of the body for 12 months for what it described as ‘bringing the pharmaceutical industry into disrepute’ over its sales of Xenical.

There was no penalty but did prompt the MHRA to launch its own investigation. However they concluded that there was no realistic chance that they would successfully prosecute the firm. Roche say that they abided by the disciplinary body of the pharmaceutical industry, but then withdrew their membership of the trade body.

The situation has highlighted uncertainty about who is responsible for disciplining pharmaceutical companies, with European, national and industry-created bodies all monitoring the actions of companies.

A shocking report has revealed that the number of children being prescribed the slimming pills Reductil and Xenical has dramatically risen over the past ten years. Though the drugs are only meant to be prescribed to adults, since 1999 the number of prescriptions being written for under-18s has climbed 15-fold.

The study has been published in the British Journal of Clinical Pharmacology and examined the use of orlistat – the medical name for Xenical and sibutramine,the generic name for Reductil. It showed that many doctors despite being advised to only offer the medications to adults are prescribing off-license.

During the period studied, 452 under-18s were given 1,334, prescriptions. Most were for 14-year-olds, though 25 of the prescriptions were written for children under 12.

The researchers also discovered that most of the patients stopped taking the medications before they had time to have any impact on their excess weight. 45% of the youngsters stopped taking Xenical after only one month, while 25% of those prescribed Reductil also stopped using it after the same time.

It was not clear whether this was due to adverse side-effects or for other reasons. One of the lead researchers, Russell Viner, said they it was possible the diet pills had been given inappropriately. He also suggested that the children had expected them to deliver a “miracle quick fix’” and then when rapid weight loss did not happen, they grew disheartened and stopped taking them.

New research has shown that front-line NHS staff feel that there is nothing they can do to reduce levels of obesity amongst children. GPs and practice nurses reported that there were limits on what they could do to make an impact on a problem they described as being primarily social.

NHS staff said that a time pressures, parental reluctance to address their children’s problems and a lack of treatment options made their job so hard they had little effect. While Xenical and Reductil are fairly widely prescribed to obese adults by GPs, they are not recommended for use by under-18s.

Currently a little less than a third of adults in the UK are obese and that figure is expected to rise sharply over the next few years. About the same amount of children are also overweight – experts estimate that about 27% of them have weight problems.

Obesity is a medical problem and can have grave consequences for health, but NHS staff say that  there were usually more pressing problems to deal with when a child visits their doctor. The medical staff also said that unless the weight was directly related to the health problem that caused the visit, they felt uncomfortable bringing it up.

They also warned that when they do see a child face to face and spot a weight problem, a lack of follow-up services means that there is little that can be done to help.

Dr. Katrina Turner, who lead the study, said that the children visiting their GPs was only “the tip of the iceberg” and called for there to be a re-examination of healthy food, where children can play and how much exercise there is on the school curriculum.

A Department of Health spokesperson said that they did not expect GPs and other primary health care professionals to solve the problem of child obesity on their own.

After the Federal Food and Drug Administration said that they were looking into reports earlier this year that orlistat could be linked to liver problems, they have now said that they are investigating 32 cases of liver damage.

Orlistat is sold in two forms, as the over-the-counter pill Alli or in a stronger-dose, prescription-only version Xenical. Xenical has been available in the UK for ten years and generally it has been considered a safe medication, though some patients have reported unpleasant side effects such as extreme flatulence.

When Alli, manufactured by GlaxoSmithKline, went over the counter, the medication received a great deal of attention from the media. It has proved to be a massive seller for the drugs company; since it hit the pharmacies in April, 200,000 people have bought the product.

The FDA said that they are looking into 32 reports of liver problems received between 1999 and 2008, nearly all of which occurred outside the U.S. Of those who fell ill, 27 of them required hospitalisation.

Compared with the number of people taking the medicine worldwide, the number of reports is extremely small and experts have said that those who are obese are at greater risk of liver damage in any case.

The FDA have said that patients should continue taking the medication as normal while the European Medicines Agency have said that they have no current plans to change the product information, though this is being reviewed.

GlaxoSmithKline responded to the inquiry by citing patient safety as their top priority and promised that reports of side effects were carefully monitored. They reminded patients that Orlistat had had extensive clinical trials and said that as orlistat is a non-systemically acting drug, minimally absorbed into the blood, there was no ‘obvious biological mechanism’ to suggest it was associated with liver damage.

A rise in the number of doctors prescribing weight-loss drugs in Scotland has dramatically increased the amount the Lothian Primary Health Care trust is spending on tackling obesity. Over two years, there has been a 20% rise in spending meaning that NHS Lothian is now spending £400,000 on slimming pills.

The rise has led councillors to question whether the prescription of slimming drugs is replacing helping patients change their diet and lifestyle. Alison Johnston, councillor, said that they needed to get away from a “culture of a pill for every ill.” She added that the money would be better spent on healthy-living initiatives.

Since 1999, the bill in Lothian for weight loss drugs has risen from £5,000, imitating the same trends seen nationwide. The rise in cost is due to developments in the medical world, which has been racing to produce more effective slimming pills.

At the moment there are two drugs which are prescribed on the NHS, Reductil, which allows the body to feel satisfied with less food, and Xenical, which reduces the amount of dietary fat absorbed by the body. Various companies are currently running clinical trials for new pills, including Orexigen Therapeutics, who recently posted good results from their clinical trials for Contrave.

A consultant at the public health department, Dr. Colwn Jones, said that the trust did offer people support in maintaining a healthy weight, citing diet, exercise and family support as key ways for people to stay trim. He added that medication was a useful help for those people who had made concerted efforts to change their lifestyle but were not successful in losing weight.

Reductil and Xenical are both licensed as last-ditch alternatives that should only be used when someone has not managed to lose weight though diet and exercise alone. Regulators also say that they should be combined with a healthy lifestyle.

Problems have been exposed with over-the-counter sales of the slimming pill Alli after a Which? magazine investigation discovered that it was possible for thin women to persuade pharmacists to sell it to them.

In May the consumer magazine sent 7 undercover mystery shoppers into 32 outlets selling the drug, including popular pharmacy chains like Boots and Lloyds. Problems were noted in 50% of the independant pharmacies and 13% of the chains. Analysing the visits, an academic and pharmacists said they were appalled that 4 times, slim researchers were able to purchase the medication.

Orlistat, the medical name for Alli and its stronger-dose, prescription-only counterpart Xenical, is only meant to be used by people who are clinically obese. Misuse can lead to dangerous side effects, the most well –known of which is flatulence and uncontrollable bowel movements.

However in all cases where the patient was the required weight, key safety questions about the patient’s medical history were asked, excepting one instance in an independant pharmacy. Three times, shoppers were not permitted to buy the slimming pill though they fulfilled the criteria.

The senior researcher who organised the study, Joanna Pearl, said that though they had expected to see excellent results after the training and guidance given to pharmacies about the sales of the drug, it was clear that independant pharmacies were still having problems.

GlaxoSmithKline, who make the medication, said that they believed pharmacists were “ideally placed” to provide customers with weight loss advice and pointed out that they had put an “extensive” training program into place to help them decide whether to make a sale or not. They added that they were committed to providing further training.  

The American Food and Drink Administration has announced plans to monitor more carefully usage of the anti-obesity medication Alli, the lower-strenth version of the prescription-only medication Xenical.

The body has received reports that orlistat may have been causing rare cases of hepatitis and other abnormalities related to the liver. The FDA have said that while they have not decided whether stricter regulation of Alli usage is needed, they will be watching out for any further reports.

When Alli was introduced, some critics said that they were worried that there would not be the same doctor’s monitoring as would be received by a patient taking Xenical. In an edition of the medical journal The Lancet, experts expressed fears that over-the-counter purchase of orlistat might lead people to perceive obesity as something that could be cured just by popping pills.

Since Alli was launched in April, regulators at the MHRA have received reports that 31 people experienced adverse side-effects from taking the pills, Some reports have suggested that pharmacists are not checking carefully enough that patients buying the slimming pills are sufficiently overweight to merit medical intervention.

It is believed that regulators will follow the lead of the FDA should they decide to introduce more stringent regulations. Roche, the manufacturers of orlistat, have denied there is a link between the drug and liver toxicity.

As Alli goes on sale this Wednesday, a variety of doctors have issued warnings that it is not a ‘miracle’ cure for being overweight. Alli is the half-dose version of the prescription-only weight loss drug Xenical (orlistat) and makers Glaxo-Smith-Kline say that users can lose up to 3lb a week.

However writing in the British Medical Journal Professor Gareth Williams, author of Obesity: Science to Practice and professor of medicine at Bristol University said he believes that over-the-counter sales will create a dangerous cultural attitude towards obesity. He wrote, “Selling anti-obesity drugs over the counter will perpetuate the myth that obesity can be fixed simply by popping a pill and could further undermine efforts to promote healthy living, which is the only long-term escape from obesity”. He also expressed the belief that users would be so put off by side effects – orlistat can in some cases, especially when patients do not follow recommendations to stick to a low-fat diet, cause flatulence and diarrhoea – that they would not finish the course of tablets.

He also warned that amount lost in trials might not be matched by dieters in real-life situations, as “dieters in these trials are highly motivated and under medical supervision.” Another weight-loss tablet that has received a lot of press coverage, Appesat, has also been hit by less-than-enthusiastic comments from a doctor. Dr. Jason Halford, Director of the Study of Human Ingestive Behaviour at the University of Liverpool, is employed by the makers of Appesat to advise them. However he has warned that no weight-loss pill can provide a magic solution, as “Drugs don’t necessarily deal with the reasons why people become obese, which are largely psychological.”

Like Professor Williams, he is concerned that pills may blind users to the need to make changes in their lifestyle. “The cure for obesity and being overweight will never be found in a pill, packet or wonder drug” he said. “That can only come from enormous changes to our food and physical environment, which are going to take a long time to achieve.”

Prescription-only weightloss drugs can definitely help support someone’s efforts to lose weight and, being stronger than those available in pharmacies, are also more effective. However whether or not someone succeeds in losing weight is very dependent on the time and commitment they are prepared to devote to slimming down. Statements like those of Professor Williams and Dr Halford are important as they highlight how drugs can help but never provide a magic wand to deal with the problem.

It has been on the cards for a while and now finally Alli, GlaxoSmithKline’s lower-dose version of Roche’s best-selling weight loss drug Xenical, is going to be available over –the- counter from UK pharmacies. The capsule is expected to be available from later in the year. It has been on sale for some time in the US and has proved extremely popular – the makers over six months saw the drug net profits of £75m.

Alli, known generically as Orlistat, works by blocking the absorption of a percentage of dietary fat. It can be very successful and the makers claim that dieters can lose up to 50% more weight than though dieting alone. However when medical advice on appropriate diet is not followed, namely if patients do not keep to a low-fat diet, it can have some very unpleasant side effects such as uncontrollable bowel movements and flatulence. GlaxoSmithKline has also warned that the drug is not a ‘magic solution’ but should be used in conjunction with a healthy diet and exercise for results to be seen. Xenical and Alli are intended for use by those with severe weight problems and a BMI (body mass index) of over 28.

The decision by EU medical authorities to allow over the counter sales will see pharmacists being trained to measure a customer’s BMI and check that those who wish to take the drug are suitable. The process will be similar to the training given when permission was given for the emergency contraceptive pill to be offered in local pharmacies. Critics have expressed concerns that as weight loss is an ongoing process, pharmacists will not be able to monitor a patient’s progress.

The Royal College of GPs has recommended that those who want the medication should first visit a doctor for advice, to see whether their obesity is caused by a treatable condition and to discuss what diseases they are at risk for. All obese patients are in danger of developing a variety of life-threatening diseases, such as diabetes and heart disease. Steve Field of the Royal College also warned, “The side effects of this drug are very unpleasant in many people. The medication should only be used with support and dietary advice.”

Nonetheless, the National Obesity Forum has backed the European Commission’s decision. They have pointed out that considering the millions consumers spend annually on untested and useless ‘miracle pills’ and fad diets, it is far better to give them access to a medication that has been rigorously tested and proven safe and effective.

We have just received information that GlaxoSmithKline has applied to the European Medicines Agency for a low dose of Orlistat to be sold over the counter throughout the EU.  Orlistat is the active ingredient in Xenical which is already available on prescription throughout the EU at a dose of 120 mg per capsule.  The new low dose of 60 mg will be marketed as Alli.  Alli is already marketed as an over the counter drug in the US and GSK claims that it can help slimmers lose twice as much weight as dieting alone.

The application has been criticised by some healthcare professionals as being irresponsible as it gives the impression that obesity has a quick fix.  There is also concern that the lack of professional advice from a doctor could be detrimental to the patient's health.

It will be some months before we know if the application has been approved and even then it is not certain that GSK will market the product throughout Europe.  We will bring you more news as it becomes available.

We have a number of overweight patients being treated very successfully with Xenical, which is a lipase inhibitor and works locally in the gastrointestinal tract to prevent the digestion and therefore the absorption of fats.  A number of patients who try the medication find that they want to stop taking it after one month as they experience unfortunate side effects such as loose bowel movements and an urgent need to have a bowel movement.  This patient compliance issue means that patients do not achieve the results that they desired as they are not prepared to continue with the treatment if they have to endure the side effects.  (It should be pointed out that for most people, these side effects disappear with an adjustment to diet and most people do not actually get the side effects.)  However, there is a new drug in development with Alizyme – a UK biotech company – which works in a very similar way to Xenical and seems to have similar weight loss results but with relatively few patient compliance issues.  The phase IIb trials demonstrated that it had 90% fewer patient compliance issues when compared with Xenical.

The new drug, known as Cetilistat, is being prepared for phase III trials.  This is a potentially very exciting development as it is not always possible to prescribe the currently available alternatives to Xenical as they are both centrally acting so are therefore not appropriate for a large number of patients.  Having this alternative treatment, which acts peripherally, will be very important for the therapeutic treatment of overweight patients.

Given that Alizyme has not yet announced details of when the next phase of the trials will commence, we are not expecting the drug to come to the market any time soon and we estimate that it could be as late as 2009.