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Glaxo Asks the Eurocrats
8 Jul 2008 13:31, Corante
... legwork, there are still some spectacular disconnects. Sanofi-Aventis, for example, did manage to get Acomplia (rimonabant) on the market in Europe (which is more than they ever managed in ...
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…over a billion people worldwide are overweight or obese, making the anti-obesity drug market big business. An estimated $1.2 billion was spent on anti-obesity drugs worldwide in 2005….. (bbc news)
“The purpose is not just to achieve weight-loss but to reduce health risk factors”
______________Dr Colin Waine
We no longer have to fatten up to face winter scarcity,
but the tradition of stuffing ourselves with seasonal delights continues. Holiday weight gain tends to be small–an average of a pound a year, according to one study–but it sticks with us and is a leading cause of obesity later in life. A little holiday overindulgence can lead to years of health problems later on. But we overeat anyway. One economist is actually suggesting cash incentives as a way to get people to shed pounds.
In Pictures: What Fat Costs America
Six in 10 people in the United States are overweight, with a third crossing the boundary into obesity. The extra weight leads to at least 100,000 deaths annually. Obese people are at a much higher risk for heart attacks, strokes, diabetes, arthritis and some cancers.
continue reading "What Fat Costs America"
Patients taking the Sanofi-Aventis anti-obesity drug Acomplia have well over double the risk of depression and anxiety, researchers said, adding to the bad news for a drug already linked to suicidal thoughts.
Danish researchers reviewed four studies featuring 4,105 patients and found that people taking 20 milligrams per day of the drug were 2.5 times more likely to discontinue treatment due to depressive disorders and three times more likely to stop because of anxiety than those who received a placebo.
The findings published in the Lancet journal follow a U.S. advisory panel decision in June that the drug should not be approved in the world’s largest drugs market because it may increase suicidal thoughts and depression.
“Taken together with the recent U.S. Food and Drug Administration finding of increased risk of suicide during treatment with rimonabant, we recommend increased alertness by physicians to these potentially severe psychiatric reactions,” Arne Astrup of the University of Copenhagen and colleagues wrote.
continue reading "Warning from Reuters"
Here are some of the things being said about Acomplia by doctors. Keep in mind that some of these may have an interest in the clinical trials underway sponsored by Sanofi-Aventis.
“If there was a pill available that was safe, effective and made it easy to lose any weight at all, there would be a truly massive market.”
Dr. Steve Bloom, researcher at Imperial College in London, quoted on June 28, 2006 by Bloomberg
continue reading "Doctors Say…"
A European regulatory review of diet drug Acomplia (rimonabant) may result in publication of new safety recommendations as early as June 29th, accordilng to a spokesperson for the European Medicines Agency (EMEA).
The EMEA said it anticipates that comments of Acomplia will be included in the monthly report of its drug safety committee which is due out on Friday.
The European review of Acomplia was triggered by the overwhelming vote of the U.S. Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee earlier this month recommending against sale of the diet drug in the United States based on currently available safety date.
Acomplia is now widely available in Europe, where the diet drug was approved by the EMEA more than a year ago, and has been purchased by more than 100,000 Europeans.
However, the U.S. advisory panel’s vote was based on newer data than that available to the EMEA a year ago — including data from post-marketing reports on usage in Europe.
While Acomplia remains on sale in European Union countries for the moment on the same basis as it has been for the past year, the EMEA may reinforce warnings about side effects associated with the drug, including depression and suicidality.
Approval of rimonabant for sale in the United States, where it was to be marketed as Zimulti, now is not expected until additional data from the large CRESCENDO trial becomes available in another two or three years.
http://www.acompliareport.com/News/news-062607.htm
Now that a promising new prescription anti-obesity drug, rimonabant, is actually available in the U.K., Germany and a dozen other countries, the launch of the most anticipated weight-loss medication since Fen-phen is generating a great deal of excitement among millions of obese and seriously overweight Americans and Europeans.
The drug, marketed in Europe as Acomplia, will be sold in the United States as Zimulti if approved by the FDA. Whatever the trade name, rimonabant has been hailed by some doctors on the basis of clinical trials as a major breakthrough in treating obesity.
The Zimulti Acomplia Report, updated daily, will track the continuing efforts of Sanofi to get rimonabant approved for sale in the U.S. The Zimulti Acomplia Report also will provide news and reviews related to rimonabant so those eager to try this new anti-obesity drug will have the latest information on availability, weight-loss results and side-effects.
http://www.acompliareport.com/
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