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by Robert MacKay, Tuesday, May 22, 2012 | Categories: Diet Pills | Slimming Pills | Weight Loss

We quite often get requests to prescribe Tenuate Dospan for weight loss. We will absolutely never do this but we thought that it might be worth our while doing a blog on the reasons why this medication should not be prescribed.

Tenuate Dospan (diethylpropion) is an unlicensed appetite suppressant that works similarly to an amphetamine, working directly on the central nervous system and affecting the heart rate and blood pressure levels. It is regarded as an unsafe substance by most healthcare professionals but is still being prescribed by a few rogue doctors at unlicensed slimming clinics.

The drug was previously licensed in the UK but the European Commission took a decision to withdraw this license in 2000. Due to the objections of the license holders, the licenses were reinstated that same year only to be taken away once again.

In 2002, the European Court invalidated the decision of the European Commission to withdraw the licenses for Tenuate Dospan. Although the drug is not banned, its use is frowned upon by most in the medical profession, given the addictive nature of the substance and the potential for long term cardiovascular side effects.

We do not deny that there is a yawning gap in the market for safe weight loss medications but it is really not worth putting your health at risk even further by consuming a medication that could hasten the sort of long term consequences of carrying too much weight anyway.

There is one exciting new weight loss medication that could be licensed very soon – Qnexa. This medication has shown huge promise in clinical trials and we believe that it will be a blockbuster medication if it is ultimately licensed.

by Robert MacKay, Monday, April 2, 2012 | Categories: Diet Pills

The votes came in at 17 to 6 last week and the advisory panel to the FDA (Food and Drug Administration) has indicated to the regulators that weight loss drugs should go through clinical trials specifically gauging potential cardiovascular risk, even if there is no reason to suspect that a particular drug might have any effect on the cardiovascular system. Some members of the committee are worried about how this will affect obesity drug research since the carrying out of such trials is expensive and is furthermore a very lengthy process.

For obesity drugs that have not signalled any cause for concern in relation to cardiovascular illness, the FDA’s committee have decided that there is no need for such drugs to carry out a cardiovascular risk assessment pre-approval and rather can wait until after the FDA has made its decision before further risk assessment commences, however these assessments will be necessary.

Another recommendation made by the committee included that patients with a higher propensity for cardiovascular risk, such as those who are heavier for example, would be included in these studies since, at the moment, patients who are at the greatest cardiovascular risk are not included.

Qnexa is unlikely to be affected since the drug actually lowers blood pressure and so it is thought that it will be appropriate for Vivus to carry out a cardiovascular study after the treatment has been approved by the agency.

These are only the recommendations of the panel and the agency is not obliged to stick to the outcome of the vote.

by Robert MacKay, Wednesday, March 28, 2012 | Categories: Diet Pills

The American drug regulator, the Food and Drug Administration (FDA), stated in a report yesterday that it may consider mandatory cardiovascular risk studies before considering any weight loss medication for approval, even if there is no evidence to suggest that there is any cardiovascular risk associated with the compound under consideration. This possible turn of events is apparently in response to previously approved medications having cardiovascular risks identified in post-marketing studies that were not picked up during clinical trials. A decision will be made on Thursday.

It is unlikely that any change in policy will have an impact on the approval of Qnexa, a decision on which will be made on 17th April. The company behind Qnexa has suggested that they carry out a trial assessing cardiovascular risk after they win approval, should they be successful. Qnexa are obviously not so quietly confident about the 17th of next month, having announced that they have recruited new employees in the areas of communications and marketing and they have also expanded the number of employees working directly on their Qnexa team.

Any mandatory cardiovascular risk study could be a very serious blow for this area of pharmaceutical research and development. It is also slightly disingenuous to suggest that some of the previously approved weight loss drugs that ended up causing heart problems did not raise red flags during clinical trial. Take Sibutramine. It was known that Sibutramine caused increases in blood pressure is some patients as well as increases in heart beats per minute; this is why we never prescribed it to patients with pre-existing cardiovascular risks. While we would never advocate a cavalier approach by regulators, we do feel that there must be a degree of proportionality when imposing new bars for approval.

by Robert MacKay, Tuesday, January 10, 2012 | Categories: Diet Pills

The Food and Drug Administration (FDA) in the US has given the all clear for phase I trials of Antipotide(a potential new anti-obesity drug), having approved Arrowhead Research Corporation’s Investigational New Drug Application. Only recently did the journal Science Translational Medicine publish research about the success of the drug when administered to rhesus monkeys. This phase I trial will be carried out by researchers at the University of Texas and will commence shortly.

A phase I trial is the first human study of a particular drug and is carried out in order to gauge the metabolic and pharmacological action of the drug in human beings where only a small number of individuals are tested at first. Side effects and reactions to the increase in dose are observed along with how effective the drug is at Phase II of the process. Participants might be healthy or patients who require treatment although specific groups are usually excluded on safety grounds.

Antipotide works by targeting the blood vessels that supply blood to white fat tissue. In the animal study, substantial weight loss and a decrease in BMI and waist circumference were observed. It is very early days for Antoptide so do not expect this medication to get a license any time soon but we will keep you up to date with the drug’s progress.

by Robert MacKay, Wednesday, June 8, 2011 | Categories: Diet Pills

Topiramate has been proven to be a successful weight loss drug for those who can tolerate the side effects that go with it according to the results of a meta-analysis of previously published studies which will be presented at The Endocrine Society’s 93rd Annual Meeting in Boston. Topiramate is used in medicine as an anti-convulsant and for the prevention of migraines.

Data on 3,300 patients who were overweight were collected and those who were taking the drug for 4 months at least, lost on average 11.8 pounds more than those taking the placebo pills but evidence of the safety of the drug as a monotherapy for weight loss is non-existent at present. The length of time one takes the drug and the dosage is the decider when it comes to weight loss achieved.

The results show that a dosage of between 96 to 200mg per day and for duration of more than 28 weeks saw the best results in weight loss. Patients were 7 more likely to lose more than 10% of their original body weight. Side effects of Topiramate included burning around the mouth, strange tastes, slower cognitive abilities and a reduction in the ability to move. Concentration and memory were also affected.

Those who took part in the study were twice as likely to stop taking the treatment as a result of the side effects than those who were taking the placebo but the weight loss experienced by those who had tolerated the side effects was more impressive than other weight loss drugs that have tried to gain the approval of the FDA in recent years. We would not even consider prescribing this drug for weight loss without a wider safety study.

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