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by Robert MacKay, Thursday, 29 July 2010 | Categories: Diet Pills | Reductil

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.

by Robert MacKay, Thursday, 24 June 2010 | Categories: Reductil | Slimming Pills

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.

by Robert MacKay, Monday, 22 March 2010 | Categories: Reductil

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.

by Robert MacKay, Thursday, 28 January 2010 | Categories: Reductil | Xenical

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.

by Robert MacKay, Tuesday, 26 January 2010 | Categories: Reductil

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.

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