It has been announced by Abbott Laboratories that Meridia (Sibutramine) is being removed from the market in the United States. The FDA’s concern over the risk of heart disease associated with this anti-obesity treatment is the reason for the recent decision.

Due to the results of the Sibutramine Cardiovascular OUTcomes Trial (SCOUT), patients taking the treatment experienced a 16% increase in the rate of non-fatal heart attacks and strokes. In addition, they felt that the weight loss achieved was not sufficient to justify risk of the side effects. Abbott still believes that Sibutramine has a positive risk/benefit profile when taken by a patient population that are not contraindicated due to previous health conditions or heart problems.

Abbot has also discontinued the marketing and distribution of Reductil (Sibutramine) in New Zealand. Those who are still taking Sibutramine have been advised to stop and speak with their healthcare provider about a more appropriate treatment for their condition.

It is possible that Sibutramine will be brought back at a later date but Abbott will have to be able to demonstrate that it is safe within the population group for whom it is intended. The fact that Sibutramine has been withdrawn and other weight loss treatments have failed to get a license now means that there are very few options available for weight loss patients.

The Endocrinologic and Metabolic Drugs Advisory Committee of the FDA yesterday considered clinical data on Sibutramine, marketed in the US as Meridia. 8 members voted to withdraw Sibutramine and the decision was split with six members in support of a thorough warning on the label with distribution limited to specially trained healthcare professionals and two members suggested a box warning only and follow up medicals on patients receiving the treatment with regular blood pressure, heart rate and body weight check- ups. Those panel members who were in support of rigorous patient monitoring with the limiting of the distribution of Sibutramine argued that its withdrawal would leave doctors and patients without much choice as the number of weight loss medications is severely limited. It was also argued that the moderate weight loss achieved in the clinical trial could translate into big overall health benefits.

Abbott, the manufacturer and patent holder, has long argued that the clinical data being considered was largely irrelevant given that most patients receiving the treatment were actually contraindicated in normal clinical practice, therefore nullifying the legitimacy of the outcomes observed in terms of application to the correct patient population. Having said this, Abbott has not been intransigent but has made a number of helpful proposals in terms of ensuring that the medication is used as intended.

We would not like to hazard a guess as to where the FDA will go with this one but we should know very soon. If the FDA does decide to keep Sibutramine on the shelves then we would expect Abbott to make approaches to the European Medicines Agency, which banned Sibutramine back in January.

The Endocrinologic and Metabolic Drugs Advisory Committee is considering Lorcaserin (a new weight loss medication) as I write, so we will bring more news on that as it comes through.

Sibutramine was taken off the market in Europe in January having been linked to an increased risk of cardiovascular events. No action other than label changes were taken in other major markets such as the US and Canada. The decision was based on an interpretation of a seven year trial: Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event (SCOUT) and today the FDA Advisory panel will decide the future of the drug in the US. The results from this six year randomized clinical trial will be debated and the manufacturers, Abbot, hope that Sibutramine will remain on the approved list.

Dr. Eric Coleman, MD and deputy director of the Division of Endocrinology and Metabolism Products reviewed the drug’s efficacy in contributing to weight loss. A 2.8% reduction in body weight after 6 weeks was noted with the consumption of 10mg per day and beneficial lifestyle changes.

After randomization to Sibutramine whilst following a newer and healthier lifestyle, a decrease of 4.8% of weight after 12 months was noted with a slight increase after the twelfth month. At the 60^th month, the difference in weight between those taking Sibutramine and those taking the placebo was roughly 2.8%. The average systolic and diastolic blood pressures and heart rates of those taking Sibutramine were higher than those taking the placebo.

Abbot stated that people with a history of cardiovascular illness were included in the SCOUT trial despite being contraindicated for this drug. The company maintains that the SCOUT study does satisfy benchmarks for weight loss drugs when taken by the right people. The SCOUT study proved that it should not be used incorrectly when taken by those with existing cardiovascular conditions. Abbott recognises however that due to changes in blood pressure and pulse rate, that the US label needs to be reviewed. If Sibutramine gets the all clear in the US today, then we would expect Abbott to lobby the European Medicines Agency for an urgent review of the data from the SCOUT trial.

The race is on for the most effective and safest anti-obesity drug. Abbott, the makers of Meridia (Sibutramine) and Arena, the makers of Locaserin, are going head to head in September at the FDA in the US. Abbot will present to an advisory panel of the US Food and Drug Administration who will be reviewing on-going post-authorization clinical studies into the controversial drug Sibutramine on September 15th. The following day, the same panel will review the clinical data on new drug candidate, Lorcaserin.

Sibutramine, also known as Reductil, was only taken from the shelves in January after the European Medicines Agency (EMA) recommended its suspension after a 6 year study which revealed that patients taking Sibutramine showed an increase in the risk of non-fatal cardio vascular events where there was a pre-existing cardiovascular problem. The problem with this study was that it concentrated on a population group actually contraindicated for sibutramine under the terms of its marketing authorisation, leading many experts to criticise the decision of the EMA. Abbott is confronting the regulators again and is hoping to generate a different sort of recommendation.

The Endocrinologic and Metabolic Drugs Advisory Committee will review Lorcaserin just one day after Abbott’s meeting with the FDA. It is anticipated that the result for Loracserin will be positive given that it appears to meet the benchmark criteria in terms of weight loss and the side effects appear to be minor. Also, unlike Qnexa, which got the thumbs down last month, Lorcaserin has been studied over two years. Lorcaserin, in its phase III of clinical testing, triumphed when 7% of both the Lorcaserin users and the placebo users stopped taking the treatment due to the experiencing of uncomfortable side effects.  Lorcaserin has the lowest discontinuation rates of any anti-obesity treatment.

Whilst we desperately need new treatments to help with the burgeoning problem of obesity, we need to make sure that the risks associated with taking any new drug do not outweigh the benefits.

Abbott has announced the voluntary withdrawal of their weight loss drug, Reductil, from the Australian market today. Doctors have been asked to stop filling out prescriptions and patients have been advised to discuss the alternatives with their prescribing doctor.

Reductil is a modest sized product for Abbott in Australia despite its popularity in the USA under brand name, Meridia, and the popularity the slimming pill once enjoyed in Europe. The FDA has yet to make a decision on whether Merida may remain licensed in the US but it does not seem in any particular hurry to withdraw the drug. If Sibutramine remains licensed in the US, then we believe that the European Medicines Agency will be approached to re-examine the license withdrawal of Reductil in the EU although we do expect the EU regulator to request specific information relating to the intended patient population in terms of safety and efficacy.

Australia’s Therapeutic Goods Administration (TGA) restricted the condition under which a Reductil prescription could be issued a few months ago. They reported that the drug’s safety and efficacy was still not clear amongst the patient group for whom it is intended. The drug was voluntarily pulled by Abbott after talks with the TGA.

Reductil is still available in New Zealand.

The Food and Drug Administration in the US has removed the dietary food supplement, ‘Joyful Slim’ from the shelves following evidence that it contains the drug Sibutramine.

This news follows the suspension of Sibutramine’s license in the EU in January of this year. Along with the once successful weight loss pill, Reductil, Sibutramine is found in Zelium, Reduxade, Ectiva, and Meridia – all of which have been licensed at some stage. Sibutramine has been connected to an increase in blood pressure and cardiovascular related illnesses such as heart attacks and strokes in certain patients. Other side effects include, mood swings and chest pain. The jury is currently out on whether Sibutramine is safe for people with no pre-existing cardiovascular problems.

The removal of Joyfil Slim does not affect any licensed product containing Sibutramine, such as Meridia, which is still licensed as a controlled substance by the FDA.

Researchers from New Zealand have released a report claiming that Reductil, the recently-banned slimming pill, has a better safety profile that it has been credited with by European regulators.

While the drug is no longer available in the European Union, it is still approved in New Zealand.

The new study followed nearly 15,000 obese or overweight patients who has been prescribed the drug. In their summary, the authors pointed to crucial differences and different results to those obtained from the American Scout study, which lead to the drug’s loss of license.

The lead author of the NZ report, Dr. Harrison-Woolrych, said that the SCOUT study showed that the overall risk of death associated with Reductil was 10 times higher than that which they demonstrated in their study.

There was also a far lower rate of death than that of the American study. Dr. Harrison-Woolrych suggested that the death rate might have been lower as the average age of the participants in the study was lower than those who took part in SCOUT.

The SCOUT study has been criticised as it involved patients with a high risk of heart problems already, though patients with a risk of cardiovascular disease are excluded from being prescribed Reductil.

The study, which has been published in the journal Drug Safety, had been greeted with cautious interest by New Zealand’s own regulators, Medscape. They are currently reviewing Reductil in light of the European ban.

The group manager for the regulators, Dr. Stuart Jessamine, said that the study showed that the drug was safer than indicated by previous studies but said that his organisation would be assessing the totality of the evidence, rather than one study in isolation.

Since Reductil was withdrawn from sale in January, we know a lot of customers have been very eager for any news as to whether this medication might be once again approved and regain its marketing license.

The European Medicines Agency originally withdrew this medication due to concerns raised by the SCOUT trial, which related to how well the medication was tolerated by people with existing heart conditions.

As the trial involved a patient group specifically excluded as candidates for the medication according to clinical practice, there was widespread consternation about the decision and we have already written in previous blogs that we expect Abbott, who manufacture Reductil , to mount an appeal against the decision.

So far, we know that Abbott have until the end of this month to put forward their objections to the European Commission, who have the power to overturn the decision.

We expect to hear more news about any decision that is taken by the middle of next month, but we will of course keep you updated if there are any further developments.

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.

There appears to be serious consternation in the medical community surrounding the suspension of the marketing authorisation for Sibutramine across the EU. Sibutramine is marketed as Reductil in the UK and as Meridia in the US. As we have reported in an earlier article, Sibutramine was withdrawn following reports from an ongoing study into the effects of Sibutramine on patients with known cardiovascular problems. As Reductil (sibutramine) should not be prescribed to this group of overweight patients, there is a strong argument that the case for the suspension of Sibutramine’s marketing authorisation was not wholly supported by clinical evidence but based on conjecture as to how the medicine might affect someone who had no previously diagnosed cardiovascular problems.

Reductil was administered to patients for 6 years to monitor its effect on cardiovascular risk in this group of patients. During the trial, the patients being treated with Reductil had a statistically significant higher occurrence of non fatal heart attacks and strokes. Reductil is normally only prescribed for one year although some doctors will prescribe it for up to 2 years and this timescale accords with the drug’s license in the US. Treating patients who are contraindicated for the medication in the first place for a period of time three times the normal maximum prescribing time must make the incidence of adverse events much more likely surely?

So how have other licensing authorities responded to this clinical trial report? The FDA in the US has not withdrawn Sibutramine but merely enhanced the warning label. The same action has also been taken by the licensing authority for Australia and New Zealand. It is our view that the decision to suspend Reductil will be overturned at a later date.

Reductil (Sibutramine) has had its marketing authorisation for the European Union suspended by the European Medicines Agency with immediate effect. As a result of this suspension, we are no longer able to prescribe this medication.

The decision was taken after an extensive ongoing trial with this medication on people with cardiovascular problems. Although patients with cardiovascular issues are never prescribed Reductil in normal clinical practice, the committee believed that the fact that for many patients the weight loss achieved was not significant and in many cases was not sustained after the treatment was ceased, this meant that the overall risks may not outweight any potential benefits.

As the trial involved a population group specifically excluded as candidates for treatment with Sibutramine in clinical practice, we do expect Abbott (the manufacturer) to mount a vigorous appeal against this decision.

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.

Consumers in Hong Kong have been warned not to take a slimming product after it was discovered to contain two medications only liscensed to be taken with a prescription. Health officials obtained a box of 2 Day Diet during an internet auction and then sent it to a laboratory to be tested.

The laboratory technicians said they proved that the capsules contained sibutramine, the active ingredient in the diet pills Reductil. They also found phenolphthalein, which was once prescribed to treat constipation. It has since been banned however after it was linked to cases of cancer.

The crackdown on the product came after a joint operation between the Department of Health and the police. They warned that sibutamine as well as only being available with a doctor’s prescription should be sold with a pharmacist’s supervision. When used by patients with contra-indications for the medication it can increase blood pressure and heart rate and cause serious health problems for people with heart conditions.

A spokesperson for the Department of Health said that under the Pharmacy and Poisons Ordinance, selling unregistered pharmaceutical products was an offence with a maximum penalty of two years imprisonment and a fine of HK$100,000.

They added that the public who had brought the product should stop using it immediately and advised that anyone taking medication for weight loss should first consult their doctor.

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.

The FDA have issued further warnings over weight-loss supplements sold over the counter in America after it was discovered they contained the active ingredient in the slimming pill Reductil

The laboratory of the FDA conducted tests on various products sold by ABC Beauty Supply International, which confirmed that a variety of products contained sibutramine. The products concerned did not contain the sibutramine on the list of ingredients and were being sold freely in pharmacies.

Sibutramine acts as an appetite suppressant as it interferes with the messages the stomach sends to the brain when it is full.

Though sibutramine is approved by the FDA and by European medicines regulators it is only meant to be sold with a doctor’s prescription. Sibutramine can be dangerous when taken by patients with a pre-existing heart condition, hypertension or by those who are at a higher risk of having a stroke. While it is fairly widely prescribed to help obese people lose weight, it should only be used by someone with a body mass index of over 30, partly why it is only available after seeing a doctor.

The FDA have asked ABC Beauty Supply to recall a number of their products, including ProSlimPlus, 24 Hours Diet and Royal Slimming Formula. They agreed the voluntary action and said that they regretted any inconvenience to customers.

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.

Canadian Health Authorities have issued a warning about a supposedly natural slimming product called “Nutural Slim” which has been discovered to be a potential health hazard. Federal officials discovered that the product contained the prescription-only weight loss medication Reductil, though this was undeclared on the product packet.

The product is manufactured by Chinese company Yingtai TCM Pharma Co. and is not licensed for sale in Canada. Health officials warned that no one should take Reductil without a doctor’s prescription and listed the possible side effects, which can include increased blood pressure, chest pain and difficulty sleeping.

There are strict guidelines as to who can take sibutramine, the active ingredient in Reductil. It is not advised for use by pregnant women or by anyone who suffers from depression or psychiatric illness. However, as the makers of Nutural Slim were not disclosing all the ingredients, it is very possible that patients contraindicated for sibutramine inadvertently took the medication, thereby putting their health at risk.

The product has been recalled by the distributor from the market place and health officials have advised retailers to remove Nutural Slim from their shelves and consumers to take back the product to the shop from where they bought it. They have also asked consumers not to buy the product from internet sellers.

Every day we get at least one telephone call or e-mail asking about phentermine, which is a slimming aid with a molecular structure very similar to amphetamine (speed.)  No matter how much we point out the dangers of this medication, a few people still seem determined to get their hands on the treatment as they have heard that it can have a dramatic impact on appetite.  Whilst this may well be the case, we are aware of very serious short and long term side effects of taking this medication and are not prepared to prescribe it under any circumstances.  No matter how much people beg and plead, there is no way that we would expose our patients to the potentially very serious consequences of taking this drug.  Although phentermine was withdrawn from the European market a few years ago, it did have its license reinstated but for very short term use only.  Even with its license now back in place for short term use, it is unlikely that any doctor worth his or her salt would be prepared to issue a prescription for the drug – especially when there is now a choice of medications which are effective in the management of obesity and with much better safety profiles than that of phentermine.

For patients who are overweight or obese we are prepared to prescribe one of three medications only.  Xenical is a lipase inhibitor with a very good safety profile.  This works by filtering out a certain proportion of dietary fat, thereby forcing the body to tap into fat deposits.

Another treatment is Reductil which affects appetite and trains patients to control food portions consumed by blocking the reuptake of two neurotransmitters released when we eat.  As a result of the reuptake of these two neurotransmitters being blocked, the feeling of satiety kicks in much earlier than would otherwise be the case.

The final treatment is Acomplia which was launched in June 2006.  This medication also affects appetite and appears to be particularly helpful in aiding the reduction of the dangerous visceral fat which can accumulate around the intestines.  Acomplia works by normalising the endocannabinoid system, which is believed to regulate food intake and energy expenditure.  It has been suggested that the endocannabinoid system in overweight people is overactive, so the normalisation of this system should lead to weight loss.

So in summary, with these three very different weight loss products on the market with good safety profiles, there is absolutely no reason for patients to resort to buying phentermine with all it attendant undesirable and potentially serious side effects.