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by Robert MacKay, Tuesday, 12 October 2010 | Categories: Reductil

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 The fact that Sibutramine has been withdrawn and other weight loss treatments have failed to get a license now means that there are very few options available for weight loss patients.

by Robert MacKay, Thursday, 16 September 2010 | Categories: Reductil

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.

by Robert MacKay, Wednesday, 15 September 2010 | Categories: Reductil

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 60th 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.

by Robert MacKay, Tuesday, 10 August 2010 | Categories: Diet Pills | Reductil

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.

by Robert MacKay, Sunday, 08 August 2010 | Categories: Reductil

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.

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