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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 As we have reported in an earlier article, Sibutramine was withdrawn following reports from an ongoing study into the effects of Sibutramine on patients with known cardiovascular problems.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.

Slimming pills are big business. Given that it has been predicted that the number of obese adults on the planet will number 700 million by the year 2050 this is hardly surprising. The slimming pill that works most effectively is going to reap huge rewards for the pharmaceutical company that develops it. To some extent the cost of the drug is less important, after all people are prepared to pay a premium if the drug is proved to work.

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.