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| UK Regulator: 1 Person in 10 on Acomplia Experiences Psychiatric Side Effects |
| 07.22.07 (10:18 pm) [edit] |
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Approximately one person in 10 taking diet drug Acomplia (rimonabant) experiences psychiatric side effects and about one person in 100 experiences suicidal thoughts, according to U.K. regulators. Of some 41,000 patients treated with rimonabant since it was launched in the U.K. in June 2006, 364 "psychiatric reactions have been reported," the Department of Health's Medicines and Healthcare Products Regulatory Agency (MHRA) said on July 19th. "Amongst these, there have been 48 reports of depression, 16 reports of suicidal thoughts and one report of self-injury," the regulatory agency said. The MHRA said evidence suggested one person in 10 taking Acomplia may develop psychiatric side effects, and "approximately one patient in every 100 may experience suicidal thoughts." The MHRA advised: "If you start to experience symptoms of depression while taking Acomplia, or if you are currently being treated with antidepressants, consult your doctor. "If you have had depression in the past but feel well on Acomplia, you should continue treatment with Acomplia and discuss your treatment with your doctor at your next routine appointment." The European Medicines Agency, however, took a more aggressive approach, deciding that Acomplia can remain on the market but with tougher warnings against its use by persons with major depression or anyone on an antidepressant. The EMEA's Committee for Medicinal Products for Human Use (CHMP) said "too many patients are taking Acomplia at the same time as antidepressants, even though Acomplia is not recommended for use in patients also taking antidepressants." While the CHMP said "Acomplia must no longer be used in these patients," it concluded "that the benefits of Acomplia continue to outweigh its risks, except in patients with ongoing major depression or taking antidepressants." Source: http://www.acompliareport.com...;
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| Weight-loss drugs and supplements can have side effects |
| 07.16.07 (11:31 pm) [edit] |
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The new drug on the market is Alli . It is the first over-the-counter weight-loss drug that has been approved by the Food and Drug Administration. Other weight-loss drugs or supplements fall into a category that is not tested by the FDA. Such supplements are not allowed to claim that they cure or prevent disease and if the claims made do seem promising then the FDA does not back it up. However, this new drug has been tested. I still warn you to be cautious since many drugs have side effects and interactions that are not found until the drug has been used for some time. The fact that the FDA has approved its proper use is helpful in determining a level of safety and efficacy. The drug, Alli, claims to help you lose 50 percent more weight than what you would lose on just exercise and diet alone. It is not suggested for use by those who need to lose only a few pounds. Alli is a drug that blocks the absorption of fat by the body. This can lessen the amount of calories that your body absorbs and thus, helps you lose weight. It works as an enzyme that attaches to the fat molecules that enter your body. It blocks about a quarter of the amount of fat absorbed as calories. What isn't absorbed is carried out of the body. Therefore, if you eat too much fat in your diet, the excess fat can leave your body in a not-too-pleasant way. There are side effects to this weight-loss plan. These are some of the side effects that www.myalli.com lists: Gas with oily spotting, loose stools and more frequent stools that may be hard to control. Those effects may not be worth the added weight loss. So I highly recommend that you try a reduced-calorie diet and a healthy dose of exercise first. The Alli weight loss plan includes daily pills as well as tailored eating plan found on the Web site. Once you purchase the package, you will be able to register for myalliplan for free. You can also take a quick quiz on the Web site to see if you are a good candidate. General questions are if you are: willing to try to lose weight gradually, committed to eating a low-calorie, low-fat diet (15 grams or less a day), committed to eating smaller portions, understand the possible side effects, make more time to be physically active and if you will read the label and follow directions properly. It is also recommended that you only do this program if you have significant weight to lose. As with any weight-loss program, you should consult with your physician before starting. There are other fat blocking-supplements and drugs, including Orlistat, that you have to get through a prescription, and chitosan, which is derived from shellfish. Do your research and remember that many weight-loss supplements are not tested by the FDA and have a greater risk for side effects and improper ingredients. Another thing to consider is the cost. You can take up to three capsules a day and the starter pack contains 90 capsules. The starter pack costs roughly $60 and the refill container contains 60 capsules at about $50. That between $2 and $2.50 a day. If you decide to try this plan, then make sure you change your lifestyle habits so that when you quit the program, you can maintain your weight loss and control the things that got you where you are. It is imperative that you find ways to change lifestyle habits and if a program like this can help you lower your calories and fat intake, then it is helping you gain some control and balance. Make sure that the program leads you be to a healthier person inside and out. Source: http://www.statesmanjournal.c...;
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| Obesity Drug: A Weapon for Cancer? |
| 07.08.07 (10:07 pm) [edit] |
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A drug used to treat obesity has some benefits for a completely different disease -- cancer. Five years ago, scientists at Wake Forest University School of Medicine were surprised to find the drug orlistat (Xenical or Alli ) could kill cancer cells. Now, they report on how it works. The drug binds and interacts with a protein found in tumor cells, blocking its function and causing the cells to die. The protein is known as fatty acid synthase. It is found in many tumor cells including those of the prostate, breast, colon, ovaries, liver, lung, and brain.
"High levels of fatty acid synthase correlate with a poor prognosis, so it is a great treatment target," assistant professor Steven Kridel, Ph.D., of Wake Forest University School of Medicine, was quoted as saying. "This makes an exciting treatment target because, theoretically, you don't have to worry about harming nearby healthy tissue."
Researchers say orlistat alone cannot treat cancer because while the drug can kill cancer cells in the lab, it is designed to act only in the digestive tract in humans. Now, the goal is to develop a drug like orlistat that can go through the bloodstream to the site of the tumor.
Wake Forest scientists have screened hundreds of thousands of compounds to find the ones that interact with cancer cells like orlistat does. They have narrowed down the list to a dozen and will now work to optimize the compounds to determine if they can create a potent cancer treatment.
Fatty acid synthase is also found in fat cells. This suggests if scientists successfully develop a drug to treat cancer, it could also be used to treat obesity. SOURCE: Nature Structural and Molecular Biology, published online July 8, 2007
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| The no khaki diet |
| 07.04.07 (2:04 am) [edit] |
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Alli , the much anticipated, fat-blocking diet pill has been on pharmacy shelves for around three weeks now and the drug’s future is still beyond speculation. In effect, the pill is a low-dose, FDA approved version of the prescription only, Xenical, both of which prevent the body from absorbing around a quarter of ingested fat, according to Alli manufacturer, Glaxo Smith Kline. But, controversy still surrounds the drug and many wonder if shedding a few pounds is worth the hassle. Alli has been in the news for a number of reasons. For one, it is one of the first diet pills sanctioned by the FDA. But, the real headline maker for the pill has been its unsettling side effects, which, according to the manufacturer, can include uncontrollable diarrhea and “gas with oily spotting.” These “treatment effects” can be so explosive that the company has recommended that users pack a change of clothes until they can acclimate to the drug. Certain Glaxo Smith Kline message boards dedicated to the pill’s side effects are a horror show of detailed bodily functions. One user recently described a bout with treatment effects at her office, though luckily, she says, “it didn’t soak through to my chair.” “I believe the fries are what did it,” another poster speculates. “…I had some strange oily deposits. Like when you put oil in water but only an orange color.” Some critics argue that the relatively low weight loss results don’t warrant the risk of potentially inflated dry cleaning bills. Mike Adams, a consumer health advocate, recently charged that the drug was barely effective in clinical trials and that users could have achieved the same weight loss by simply cutting out a thousand calories per week. Other critics worry that the drug may also block healthy fats. The pill seems to be selling well through it all. And the majority of users have reported no ill side effects. In fact, some were upset that they didn’t experience treatment effects and claimed to intentionally eat fatty foods to see what would happen, often with no yucky results. Others claim to have lost 5 to 10 lbs in the first week of treatment with no side effects at all. At the end of the day, the equation is simple: the more fat you eat while taking Alli, the more will be passed through and discharged. In some ways the side effects are more incentive than anything to eat lower fat meals. “It makes me stick to a diet,” one user admitted. “I know what will happen if I don’t.” Source: http://www.columbiacitypaper....;
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| Heavy side effects for weight loss pill |
| 06.29.07 (10:46 pm) [edit] |
Alli, first FDA-approved over-the-counter weight loss product, is now available in local stores.The first FDA-approved over-the-counter weight loss product is now available in area stores, but some of the objectionable side effects have caused people to pause. Alli , pronounced like "ally," is a lower dose of orlistat, the same ingredient in prescription drug Xenical. Alli's makers, pharmaceutical company GlaxoSmithKline, recommend a reduced-calorie, low-fat diet while taking Alli. If not, side effects include gas, diarrhea and other digestive symptoms. "(Alli's) function is to decrease absorption of fat in the gastrointestinal system," said Dr. David Westbrock, an endocrinologist and director of New Profile Weight Management Center in Centerville. Vitamin supplements are suggested while taking Alli, because as the drug decreases fat absorption, it also decreases vitamin absorption, Westbrock said. Julie Burns of Xenia said she has tried other weight loss aids and would consider Alli. "I just needed that extra boost," she said, outside of a Gold's Gym in Beavercreek. Bob Castor of Beavercreek also was willing to give it a try: "I've taken a few fat burners before, but I haven't really seen the results like they say. But I'd probably give it a try." Beavercreek resident Chad Beaver was not going near the product. "I've looked at what's in a lot of (weight loss products)," he said. "They seem like a joke." Westbrock said, like every other weight loss supplement, Alli is "not a magic pill." Alli can be purchased in 60- and 80-pill starter kits, which include Alli, a pill case and weight loss guides with online support. Prices range by pill count and by store, and are around $50 to $70. Source: http://www.daytondailynews.co...;
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| Nutritionists weigh in on new weight loss aid, Alli |
| 06.27.07 (11:47 pm) [edit] |
Christina Cesario works out five times a week. She says she'd try the new FDA approved diet pill, Alli . "I would definitely be interested in trying it and see if it helps me loose a few more pounds and how it makes me feel,” said Cesario The makers of Alli claim it can help its users lose 50-percent more weight than dieting alone. An example they use is, if you loose 10 lbs on your own, you'll loose 15 with Alli. Nutritionist Kelly Waters says, “I'm afraid that they’re gonna say well this pill is great. I'm just going to take this pill and be okay, when really that's not how it is." Alli creators say the pill works on the digestive system. Officials say the Alli prevents enzymes in the intestines from digesting about a quarter of the fat a person eats. But if you don't stick to the recommended diet plan Alli officials say there could be "treatment effects." “If people take this pill and they continue to eat fried foods, trans fats, that's when they're definitely going to have the gastrointestinal distress. It will not agree with their body," said Waters. For some that's enough to stay away from the pill. Eric Patrick says he’ll never use diet pills. "I probably wouldn't use it. No I think that I would just go ahead with the vegetables and fiber,” said Patrick. Nutritionists say just because the pill is FDA approved, doesn't mean it will perform miracles. Nutritionists say some of the fat Alli passes out of the body is fat the body needs. Like Vitamin A, D, E and K. Alli is only for people age 18 and over. The makers of Alli say most weight loss occurs in the first six months of use. A 60-pill "starter pack" sells for $49.99, while one with 120 pills goes for $69.99. Source: http://www.scnow.com/
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| Diet Drug Acomplia (Rimonabant) Users in Germany Get Bad News on Reimbursement |
| 06.20.07 (11:22 pm) [edit] |
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Diet drug Acomplia users in Germany got bad news on June 20th when a Berlin court upheld a German regulatory body's decision classifying rimonabant as a "lifestyle" drug not eligible for reimbursement by German state health insurers. The court upheld a decision by Germany's Joint Federal Committee (G-BA) last October that Acomplia should be placed on the country's negative list which specifies those products which are not reimbursed. A month's supply of Acomplia in Germany runs about 100 Euros (U.S. $130). Nine out of 10 Germans are charged only a co-pay for drugs covered by state insurance, and in the case of Acomplia, the co-pay would have been about $10. Today's court decision rejecting an appeal by Sanofi-Aventis means patients in Germany will have to pay for the entire cost of Acomplia out of their own pocket. Almost 50,000 Germans were prescribed Acomplia between June and November of last year, according to documents released last week in the U.S., making Germany the biggest market thus far for the medicine. The decision was the second piece of bad news in a week for Sanofi-Aventis, which was rocked by an FDA advisory panel recommendation that rimonabant not be approved for sale in the United States because of safety concerns. Acomplia is the first in a new class of drugs that works by blocking CB-1 receptors, and the drug has been linked to an increased incidence of depression and "suicidality." The European Medicines Agency, which approved sale of Acomplia in the European Union more than a year ago, is reviewing the FDA committee's decision and new data that was presented at the U.S. meeting. Source: http://www.acompliareport.com...;
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| If You Want Acomplia (Rimonabant), You Won't Find It Anywhere as Zimulti |
| 06.19.07 (11:49 pm) [edit] |
In the wake of the diet drug rimonabant (Acomplia / Zimulti) debacle on June 13th, there is no need for millions of Americans eager to try Acomplia to look for it under the new name Zimulti. Barring a miracle, rimonabant will not be approved by the FDA for sale in the United States -- where developer Sanofi-Aventis intended to use the trade name Zimulti -- for at least another two or three years. In Europe, the Middle East, Latin America, Mexico and all other countries (a total of 38 now) where the drug is either already on sale or where launch is pending, Sanofi's rimonabant will continue to be sold as Acomplia . It was never Sanofi's idea, of course, to change the name from Acomplia to the rather odd name Zimulti anyway. The FDA more than two years ago made it clear that it was not going to permit Sanofi to use the name Acomplia, which it thought was too suggestive that the drug would let overweight individuals "acomplish" their weight loss goal. But while Sanofi heard this message and somehow came up with the name Zimulti for the U.S., the FDA briefing June 13th of the Endocrinologic and Metabolic Drugs Advisory Committee made it clear how Sanofi totally misread the level of concern of FDA staff over safety issues associated with Acomplia. With new trials unlikely to provide the type of safety data sought by the FDA until the large CRESCENDO study, with 17,000 participants, reports in January 2010, the prospects of the FDA agreeing to some interim analysis that allows Zimulti to come to market earlier seems extremely low. Hence, if you are in Mexico, various Caribbean islands, or Europe this summer and are hoping to try rimonabant, keep in mind that the name of the drug you are seeking is Acomplia -- not Zimulti. Source: http://www.acompliareport.com...;
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| UPDATE: FDA Sees Problems With Sanofi Diet Drug Acomplia |
| 06.11.07 (10:26 pm) [edit] |
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Regulators at the Food and Drug Administration are concerned that a proposed weight-loss drug by Sanofi-Aventis called Acomplia may carry a significant risk of triggering suicidal thoughts, according to documents released Monday. In briefing documents released on the company's website, FDA reviewers noted that while Acomplia did appear effective in significantly lowering weight, users also had a higher incidence in certain suicidal behavior. The documents were released ahead of an advisory panel meeting on the drug's market application, which is scheduled for Wednesday. While the agency is not bound to the recommendations of its advisory panels, it often follows them. Acomplia , also known as rimonabant, was approved in Europe for weight loss in June 2006. However, the FDA has been leery of approving the drug over concerns that it can spark depression or suicidal thinking in some users. French drugmaker Sanofi (SNY) first submitted its application for U.S. approval in April 2005. In February 2006, the FDA ruled it needed additional information on the drug's psychiatric side effects before it could consider approving it. Sanofi submitted the information in October 2006. A final decision on Acomplia is expected by the end of July. Source: http://money.cnn.com/
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| Big Week Ahead as alli Goes on Sale & FDA Weighs What to Do About Rimonabant |
| 06.11.07 (1:09 am) [edit] |
A big week lies ahead for would-be dieters with over-the-counter diet pill alli (low-dose Xenical) set to go on sale on Friday June 15th and long-awaited prescription diet drug rimonabant (Acomplia / Zimulti) facing its moment of truth at the FDA. The biggest question still hanging over alli, the only diet pill ever approved by the FDA for nonprescription sale, is whether supplies in pharmacies, supermarkets and retailers like Target and Wal-Mart will be sufficient to meet initial demand. But a lot of big questions continue to dog the Sanofi-Aventis prescription drug rimonabant, which has been on sale as Acomplia in Europe for more than a year even though it remains stalled under a cloud of mystery at the FDA. Some hints as to rimonabant's immediate future in the United States should be a lot clearer by the end of this week. On Tuesday, June 12th, the FDA staff will for the first time reveal its views on the long-delayed diet drug. The following day, June 13th, the agency's Endocrinologic and Metabolic Drug Advisory Committee, a panel of outside experts, will air various concerns about Acomplia and its side-effects, and vote on whether to recommend FDA approval. While the FDA does not have to follow the recommendations of its advisory committees, it generally does -- and the combination of the staff report and the advisory panel vote should strongly signal what to expect in July when the regulatory agency's decision on approval of rimonabant is now due. In a best case scenario for the developer of rimonabant, Sanofi-Aventis, Zimulti -- as it will be known in the United States -- could be on the market by early fall. In a worst case scenario (well, not the absolute worst), the FDA could ask for more trial data while keeping Zimulti off the U.S. market and leaving it to be available in Europe and many other countries (and by mail-order via the internet) for another couple of years. If history is any guide, the FDA's release of its review of rimonabant will identify issues that have concerned regulators since Sanofi-Aventis first sought approval of rimonabant in the United States two years ago. Sanofi during this time has provided very few hints of what was holding up action at the FDA. But it long has been apparent that the FDA's questions for the most part do not involve the effectiveness this novel obesity treatment, which works by blocking the CB1 receptor in the brain, but center on the neuropsychiatric side-effects reported during the Acomplia clinical trials. Not only were worrisome instances of anxiety, depression and nausea experienced by a number of participants in the trials, but concern also has been voiced over the high drop-out rate from the trials among participants getting the dose of Acomplia submitted for approval to the FDA. Sanofi-Aventis has consistently downplayed concern over rimonabant's side effects, and has said it will be "pleased to have the opportunity to present its data on rimonabant and to exchange with experts" at Wednesday's advisory committee meeting. But with the FDA freshly focused on safety concerns as a result of the recent furor over whether regulators were slow in getting out safety data on a GlaxoSmithKline diabetes drug, Sanofi and its hopes for rimonabant may well be in for a rocky week. Source: http://www.dietdrugreport.com...;
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| Sanofi-Aventis announce the launch of Acomplia in the UAE |
| 06.04.07 (11:32 pm) [edit] |
Sanofi-Aventis announced the launch of Acomplia (rimonabant), their new scientific drug for the treatment of abdominally obese patients with cardio metabolic risk cluster.The drug has received approval from the European Medicines Evaluation Agency (EMEA) to be used in combination with diet and exercise for the treatment of abdominal obesity with cardio metabolic risk cluster, and is already sold in over 12 European countries , including Germany and the UK. In the Middle East the prevalence of obesity increases from an average of 6% in healthy children to 20% in adolescent males and to a further 32% in elderly patients. Recent results from the IDEA (International Day for the Evaluation of Abdominal Obesity) survey, a 63 country study, including the UAE has shown that 37% of the UAE population is obese (using waist circumference measurement). Previously, most obesity experts considered that total body fat - as estimated by the body mass index (BMI) - was the main predicator of weight-related disease, now it is understood that location of body fat is equally if not more significant. To be specific, excessive body fat stored around the stomach and abdomen (abdominal obesity) is believed to be a better predictor of weight related diseases such as diabetes, and cardiovascular diseases. According to Dr. Matthias Blüher, Professor of Internal Medicine, University of Cologne, 'Obesity and diabetes have reached epidemic proportions worldwide. The UAE is now ranked second in the world for diabetes, which is largely caused by abdominal obesity. This new drug acomplia when used in conjunction with lifestyle modifications offers an important breakthrough in the fight against abdominal obesity and its associated risk factors such as type 2 diabetes.' The new abdominal obesity drug can significantly improve blood sugar levels in patients with type 2 diabetes while also helping them reduce their weight. Acomplia works by selectively blocking receptors found in the brain and in peripheral organs important in glucose and lipid metabolism, including adipose tissue, the liver, gastrointestinal tract and muscle. The drug acts to decrease the over activity of the endocannabinoid system (EC system). The EC system is a recently characterized physiological system that includes receptors such as the CB¹ receptor, and it is believed to play an important role in regulating body weight and in controlling energy balance, as well as glucose and lipid metabolism. According to Dr Wael ALMAHMEED, Vice President of Emirates Cardiac Society, 'Among people who are overweight or obese, it is those with excess fat around their abdomen who are at the greatest risk of developing an abnormal lipid profile, type 2 diabetes and ultimately heart disease. Rimonabant is an important advance in the treatment of cardio-metabolic risk factors which contribute to the global risk for diabetes and cardiovascular disease.' The launch will also feature an evening symposium for UAE doctors on the risks of abdominal obesity. This is being run in conjunction with the 'Your Health Matters' awareness campaign which is being run in association with the World Health Organization, the Gulf Heart Association and the Emirates Cardiac Society. Source: http://www.ameinfo.com/122377...;
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| Get Slimmer, Fitter and Confident with “Acomplia” |
| 06.01.07 (9:59 pm) [edit] |
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Growing number of obese or an overweight individuals, has made weight loss a trend amongst all age groups. Lots of weight loss medication such as Xenical, Acomplia, Phentermine, Bontril, Didrex, Phendimetrazine, Reductil, Ionamin, Hoodia diet pill, Alli , are using at high rate to enhance the scope of your weight loss. France, Germany, Ireland, Austria, Argentina, and Denmark are some other countries where it has also been launched. Italy, Spain, and Mexico are some of the forthcoming countries which can bystander the instigate of this weight loss medication. Acomplia is emerging as one of the most desirable weight loss medications, which is marking its mark with its high efficacy. Acomplia provides weight loss in an effectual way by reduces your appetite and enabling you to eat in small portions. Its efficacy for weight loss is proven by the long trail of success stories of its users. Acomplia is a product of two years of clinical studies, which works on the basis of an appetite suppressant. Acomplia may cause a few adverse effects as a consequence of bodily changes in to this medication. Yet, regardless of the adverse effects it sources such as anxiety and feeling of depression, Acomplia is still preferred by obese and overweight individuals to lose weight rather than any traditional weight loss program. Weight Loss Drug is a dependable knowledge encouragement on diet pills. Acomplia is also popular as slimming pills among obese. Acomplia ‘slim pills’ are easily available in the market. You can even purchase them online and avail of special prices that the online pharmacies offer from time to time. Online consultation, cheaper prices, convenient payment means and home delivery make this type of shopping a great experience. Fact is that it will be subsequent benefits to your health whenever you lose just 10 percent of your initial body weight. However it is a big challenge to maintain these health and weight benefits. But you should be realistic when you set your weight loss goals. Source: http://www.businessportal24.c...;
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| Anti-obesity drug claims disputed |
| 05.30.07 (10:19 pm) [edit] |
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Claims that an anti-obesity drug offers benefits outside those associated with weight loss may not be justified, experts have said. Rimonabant (brand name Acomplia ) has been described as the "new wonder slimming drug", with trials showing it helps obese people shed excess pounds. The National Institute for Health and Clinical Excellence (Nice) is currently appraising the drug for use on the NHS. But experts writing in the Drug and Therapeutics Bulletin (DTB), from the British Medical Journal (BMJ), questioned claims by the manufacturer, Sanofi-Aventis. They said there was no proof that the drug had any beneficial effects outside those expected by weight loss.
According to the Sanofi-Aventis website, the drug "has a beneficial effect on blood glucose and lipid levels - a more beneficial effect than would be expected from weight loss alone". Advertisements for the drug have suggested that half of the drug's effects on cardiometabolic risk factors are beyond those expected by weight loss alone. Cardiometabolic risk relates to factors that can be combined to heighten a person's chance of developing heart disease and/or type 2 diabetes. Such factors include obesity, "bad" cholesterol, fat levels in the blood, high blood pressure and insulin resistance. The DTB researchers also said the drug had not been effectively compared with other, cheaper drugs for weight loss. They cited Xenical (orlistat) and Reductil (sibutramine), which cost less and are approved for use on the NHS. Source: http://icberkshire.icnetwork....;
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| How Indian Pharmas Beat Sanofi to Market With Diet Drug Rimonabant |
| 05.28.07 (11:16 pm) [edit] |
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How is it possible that mid-sized Indian pharmaceutical companies are already selling their own versions of diet drug rimonabant in India while the original developer of the drug, Sanofi-Aventis, still doesn't have Indian government approval to sell Acomplia? Well, part of the answer may be that Sanofi was so focused on getting approval to sell the drug in Europe (where Acomplia went on sale last summer) and in the United States (where it still awaits regulatory action) that the French pharmaceutical giant was late in filing for marketing authorization in India. While a Sanofi spokesperson said the company filed last summer with India's Central Drugs Standard Control Organization, which regulates the market authorization of new drugs as well as the standards for imported drugs, Sanofi confirmed that the Indian regulatory agency has not yet acted on Acomplia. "It's too soon to tell what will be our strategy regarding the launch of Acomplia in India,'' a Sanofi spokesperson told Bloomberg News last week. Given the relatively high cost of the drug -- generally somewhat more than US$100 per month -- in the dozen plus countries where Acomplia is already on sale, Sanofi may have thought the number of Indians who would be able to afford a price of this magnitude would be relatively small. But in the meantime, Indian pharmaceutical companies that seem to have replicated Sanofi's version of the rimonabant molecule -- which apparently was never granted patent protection in India -- independently filed with the regulatory agency and received approval to sell their own versions of the drug. With at least two companies -- Torrent Pharmaceuticals and Zydus Cadila -- already selling Rimoslim and Slimona in India for under US$6 per month, the market for rimonabant in a country that has a growing urban, middle-class obesity problem may turn out to be significantly greater than Sanofi believed. Source: http://www.dietdrugreport.com...;
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| Drugs from A to Z: Alli, Avandia, Acomplia & Zimulti |
| 05.23.07 (9:39 pm) [edit] |
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In the middle of the Avandia blowup, GlaxoSmithKline this week is launching the new over-the-counter diet pill "Alli ." The company says it's spending 150 million bucks on the first-year marketing of the formerly prescription-only Xenical from Roche.
A big chunk of that is going toward a multi-pronged educational campaign to convince dieters they have to change their eating habits and exercise if they want to get the maximum benefit from Alli. That's crucial with this drug because the more fat you eat, the worse the gastrointestinal side effects. Clue: Glaxo is telling Alli users to wear dark pants and bring an extra pair to work. The company has gone so far as to set up an exhibit in New York City this week where people can get more information about Alli.
But if the side effects don't sound appealing, dieters can eat less and exercise more and/or wait a couple months. Sanofi-Aventis is waiting for FDA approval of its diet pill formerly known as rimonabant and Acomplia and now being called "Zimulti." That's right... Zimulti.
Apparently, the FDA balked at the proposed name of Acomplia because it sounded either too much like "accomplish" or like an existing drug on the market. How they went from Acomplia to Zimulti (from A to Z), though, is beyond me.
Anyway, the middle of next month, the drug goes before an FDA Advisory Committee. And the FDA is scheduled to make a decision on whether to approve it by the end of July. So far, tests show it helps people lose weight without any nasty gastrointestinal side effects. But questions have been raised about more patients on Zimulti reporting feeling depressed versus those who were on the placebo.
Meantime, there's more news regarding Avandia. The British medical journal, The Lancet, is pooh-poohing the Avandia study in The New England Journal of Medicine. The Lancet writes in an editorial published online today that "...it would be premature to overinterpret a meta-analysis that the authors and NEJM editorialists all acknowledge contains important weaknesses. To avoid unnecessary panic among patients, a calmer and more considered approach to the safety of (Avandia) is needed. Alarmist headlines and confident declarations help nobody."
A meta-analysis is essentially a review of data from a bunch of clinical trials. It is not considered the gold standard in medical research. That said, the Cleveland Clinic's Dr. Steven Nissen, who did the meta-analysis, stands by his findings. Source: http://www.cnbc.com/id/188244...;
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| Diet Pill alli (Low-Dose Xenical) to Go on Sale June 15th |
| 05.17.07 (9:28 pm) [edit] |
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Diet pill alli (low-dose orlistat) will officially go on sale on June 15th, according to distributor GlaxoSmithKline Consumer Healthcare. While the pricing of the drug has not been officially announced, a starter pack that includes 60 alli capsules (enough for three weeks assuming that you take one before each meal), the alli Shuttle (a carrying case for your pills), and several booklets including a calorie and fat counter and a daily journal is expected to cost between $50 and $60. An alli starter pack that includes 90 alli capsules (enough for a month assuming that you take one before each meal) is expected to cost between $65 and $70. An alli refill package -- consisting solely of 120 alli capsules (enough for 40 days) -- is expected to cost between $75 and $85. Glaxo, meanwhile, has released the first two television commercials of what is ultimately expected to be a $100 million plus first-year blitz for the first FDA-approved over-the-counter diet drug. Both of the first two commercials can be viewed by those who have missed them on television via the video sharing website YouTube. As part of the prelaunch educational campaign for the diet pill that Glaxo agreed to at the insistence of the FDA, the first two commercials are very slick but soft-sell and are designed to push people to Glaxo's internet website, myalli.com, which is expected to play a major role in the company's marketing. Source: http://www.dietdrugreport.com...;
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| FDA weighs risks, benefits of new diet pills |
| 05.16.07 (11:56 pm) [edit] |
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Diet pills come and diet pills go, but still the fat clings to the collective hips and bellies of 167 million of us in the United States.
Two pharmaceutical companies are hoping that two new drugs under review by the Food and Drug Administration might do what dozens before have tried but failed to do - expunge us of some of our fat, without killing us in the process. Dozens of drugs over the years have held great promise but few have had lasting results.
"The whole history of weight-loss drugs has been very disappointing," said Morgan Downey, executive director of the American Obesity Association. "It will be interesting to see what happens with these." One drug, rimonabant, was approved in Europe in June. It is available in the United Kingdom, being marketed as Acomplia . It would be available by prescription only.
The second weight-loss drug before the FDA is for over-the-counter usage. It, too, works differently than appetite suppressants, but not the way that rimonabant does.
Alli (pronounced AL-lie) blocks the body's absorption of fat. It is a lower-dose version of the prescription drug Xenical, or orlistat, as it is known generically, which has been on the market since 1999.
Some things to know about diet drugs
Acomplia Rimonabant Blocks brain receptors
Has shown in clinical trials to lower cholesterol and triglyceride levels; manufacturer says it can significantly reduce abdominal obesity, a marker for heart disease; prescription would be required; FDA has not approved drug
Alli Orlistat Blocks absorption of fat
Has been on market for prescription use for almost a decade; to be used in concert with exercise and dietary changes; if approved, no prescription would be required for Alli; can cause cramping, diarrhea, flatulence, intestinal discomfort and leakage of oily stool. FDA approval of prescription version, Xenical , granted in 1999.
Sibutramine Meridia
Increases levels of certain brain chemicals that may suppress appetite
Should not be used by people with history of heart disease, high blood pressure, irregular heartbeat, congestive heart failure. May cause headache, dry mouth, constipation and insomnia. Approved by the FDA in 1997.
Bontril Phendi-metrazine tartrate
Appetite suppressant
Should not be used long-term; not advised for people with heart disease; approved in 1982.
Desoxyn Methamphe-tamine
Appetite suppressant
For short-term use only; not advised for people with heart disease or with a history of drug dependency; approved in 1959.
Lonamin and Adipex-P Phentermine
Appetite suppressant
Was the "phen" in "fen/phen," which was pulled from the market in 1997 because the "fen" ingredient, fenfluramine, was linked to the development of valvular heart disease and primary pulmonary hypertension. Short-term usage only. Approved in 1959. Source: http://www.azcentral.com/heal...;
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| Why Diet Pill Acomplia Will Be Diet Drug Zimulti in U.S. |
| 05.07.07 (10:14 pm) [edit] |
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After more than a year of asking, we now have Sanofi's official explanation why diet drug rimonabant -- sold as Acomplia in Europe and the rest of the world -- will be marketed in the United States (if and when it is approved) as Zimulti. According to Hanspeter Spek, Sanofi's executive vice president for pharmaceutical operations, the FDA office that passes on proposed names of drugs had "reservations" about the name Acomplia. "This division considered that Acomplia could be too descriptive or eventually misleading indicating that a patient taking Acomplia would acomplish his therapeutical target," Spek said on a conference call. "We proposed other trademarks and the FDA agreed finally on Zimulti," Spek added. Source: Acomplia Report
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| Alli Diet Pill Book Launched |
| 05.03.07 (12:03 am) [edit] |
The makers of the first government-approved non-prescription weight loss drug have launched a book to help consumers maximize their weight loss potential by taking on a healthier lifestyle. The book, Are You Losing It? Lose Weight Without Losing Your Mind, was born out of an agreement between GlaxoSmithKline, the nutritional supplement company that created the diet pill Alli, and the United States Food and Drug Administration. The federal food and drug regulator voiced concerns about the misconceptions consumers might have about how the pill actually works. The book, on supermarket and pharmacy shelves across the country, is meant to educate Alli users about the need for exercise and adopting a low-calorie diet. Alli is expected to be available to the public this summer. The drug is designed to work by blocking the absorption of fat by the body and limiting the number of calories that are absorbed. Alli users are expected to lose up to 10 percent of their body weight when they use the pill in combination with a reduced calorie diet and an exercise program. Source: http://www.dietnation.com/
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| Diet Pill alli May Also Be Available Over-the-Counter in Europe by Late 2008 |
| 05.02.07 (2:44 am) [edit] |
Diet pill alli, which is scheduled to go on sale in the United States in mid-summer, may also be available as an over-the-counter diet drug in Europe by the end of next year, according to GlaxoSmithKline. The company said on April 1st that it plans to seek European approval before the end of this year to sell alli, a low-dose version of prescription diet drug Xenical (orlistat), and hopes to launch the drug in Britain and other European countries by late 2008. The U.S. Food and Drug Administration gave the go-ahead to alli in February, making it the first weight-loss pill ever approved for over-the-counter sale in the United States. In Europe as in the United States, hundreds of unregulated products are sold as diet aids in pharmacies and supermarkets, and Glaxo is counting on the blessing by regulators to set alli apart and lead to its use by millions of dieters. "Consumers spend billions each year on fad diets, unproven miracle pills and potentially unsafe weight loss supplements that may not work," a Glaxo spokesperson said. "alli is the clinically-proven alternative to these hyped quick-fix products that mislead overweight adults away from weight-loss strategies that are backed by medical science." "My concern is that it should not be seen as a panacea for people who want to get into a smaller-sized bikini," said Dr. Colin Waine, chair of Britain's National Obesity Forum. "It may also be unpleasant - if you eat a high fat diet you will experience the effects. But if used sensibly with the right sort of dietary back-up then this could help some people." Source: http://www.dietdrugreport.com/News/news-040207.htm" title="http://www.dietdrugreport.com/News/news-040207.htm" target="_blank"http://www.dietdrugreport.com...
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| Gym pill trips fat-burning gene |
| 05.01.07 (2:23 am) [edit] |
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US scientists have devised a drug that can switch on a gene to burn body fat, offering hope of an exercise pill. Mice given the drug burned off fat, even when they did not exercise, and were resistant to weight gain despite a high-fat diet. The ultimate use would be to treat people at risk of obesity-related diseases like diabetes, rather than offer a "no-work six-pack" pill. The Salk Institute team presented their work at Experimental Biology 2007. The drug mimics normal fat and chemically triggers a gene switch called PPAR-delta. Turning on this switch activates the same fat-burning process that occurs during exercise. Lead researcher Dr Ronald Evans believes the same will occur in humans. Human trials UK expert Dr Fredrik Karpe, from the Oxford Centre for Diabetes, Endocrinology and Metabolism, is hoping to test this in the near future. Commenting on the work, he said: "There has never been a method to 'medically' switch on fat burning before. "The finding that PPAR-delta co-ordinates this process, not only by switching on fat burning, but also to rebuild the muscle in a way making it more fit for fat burning, is of major interest, not least as a completely novel approach for the treatment of the metabolic derangements accompanying obesity." But he cautioned; "Although this might become an 'exercise pill', it is unlikely to provide all the other benefits of real physical exercise." Source: http://news.bbc.co.uk/1/hi/he...;
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| Acomplia (rimonabant) is Reimbursed in Switzerland |
| 04.26.07 (1:28 am) [edit] |
Sanofi-aventis announced today that the Swiss Federal Register of Public Health has registered acomplia (rimonabant) as of May 1, 2007 on the reimbursement list.
Acomplia is reimbursed by the mandatory social security system for the treatment of type 2 diabetic overweight patients (Body Mass Index - BMI - greater than or equal 28 kg/m2) on at least one oral antidiabetic. Acomplia is furthermore reimbursed for the treatment of patients with obesity (BMI greater than or equal 35 kg/m2).
Acomplia will be available at a price similar to those obtained in the countries of the European Union.
In Switzerland, Acomplia is indicated in association with a light hypocaloric diet and physical activity for obese patients (Body Mass Index - BMI - greater than or equal to 30 kg/m2) or for overweight patients (BMI greater than or equal to 27 kg/m2) with at least one associated cardiovascular risk factor, when measures taken to reduce weight, such as diet and/or physical activity turned out to be insufficient.
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| Most Promising Emerging Agents for Metabolic Syndrome |
| 04.12.07 (1:25 am) [edit] |
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Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that emerging agents from Metabolex/Johnson & Johnson, Merck, Novartis, and Amylin/Eli Lilly are among the most promising drugs in development for metabolic syndrome. According to the new Pharmacor report Metabolic Syndrome, the emerging second-generation PPAR-gamma modulator from Metabolex/Johnson & Johnson, metaglidasen, holds promise as an insulin-sensitizer. Metaglidasen has been shown to reduce frequency of edema and reduce weight gain, two side effects that have limited the market potential of currently available drugs in this class, such as Takeda's Actos and GlaxoSmithKline's Avandia. Emerging drugs that modulate the incretin pathway-including Merck's Januvia, Novartis's Galvus, and Amylin/Eli Lilly's Byetta LAR-are all shown to improve glucose control and confer protective properties on pancreatic beta cells, making them excellent candidates for metabolic syndrome because they reduce the risk for development of type 2 diabetes. Physicians also cite Sanofi-Aventis's Acomplia , which is currently used to treat obesity, as a suitable metabolic syndrome treatment because it has been shown to improve patients' metabolic profiles in addition to causing weight loss. The report also finds that the lack of a consensus definition of metabolic syndrome and controversy about its associated cardiovascular risk continue to be the greatest barriers to effective management of this disorder. "In response to a lack of recognition of metabolic syndrome by reimbursement and regulatory authorities, pharmaceutical companies are realigning their pipelines to target subpopulations of patients who have multiple components of metabolic syndrome, such as obese patients with type 2 diabetes," said Decision Resources Analyst Donny Wong, Ph.D. "Current definitions of metabolic syndrome include patients with established type 2 diabetes, hypertension, and dyslipidemia, as well as patients with preconditions of these disorders." Source: http://sev.prnewswire.com/&nb...;
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| Acomplia Conquers Yet Again With Its Approval in Switzerland |
| 04.10.07 (11:35 pm) [edit] |
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Its recent approval for sale in Switzerland has brought droplets of fresh showers on the promising weight loss drug. Lyn Youngman senior marketing executive at Acomplia Rimonabant Pill, “Acomplia conquers yet again with its approval for sale in Switzerland. Although Swiss weight is a small market but nevertheless it marks the spread of Acomplia usage”. Acomplia received approval for sale in Switzerland on 3rd of April, 2007. it is to used only when other approaches like exercise and regulated dietary habits fail to work in sourcing weight loss. Swiss medical authorities have approved it for usage by individuals with a BMI 30 (obese); and individuals with a BMI 27 with at least one cardio metabolic risk factors. Weight loss medication, Acomplia is already approved for sale in the UK, France, Germany, Mexico, Ireland, Finland, Norway, Austria, Argentina, amid other countries.
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| Diet Drug Acomplia (Rimonabant) Approved for Sale in Switzerland |
| 04.03.07 (11:37 pm) [edit] |
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Diet drug rimonabant (Acomplia / Zimulti ) was approved for sale on April 3rd by Switzerland for treatment of obese or overweight patients with at least one type of associated cardiovascular risk. The approval by Switzerland, which is not a member of the European Union, is similar to the EU marketing approval last June, where the drug was cleared for use in combination with diet and exercise for overweight and obese patients with linked health risks such as type 2 diabetes. Sanofi-Aventis said regulator Swissmedic authorized the use of the drug for "for obese patients (BMI greater than 30) or for overweight patients (BMI over 27) with at least one associated cardiovascular risk factor, after insufficient weight reduction following physical activity or alimentary adaptation." Switzerland is a relatively small market, and the news of Acomplia's approval hardly offsets recent disappointing announcements on reimbursement by state social security systems in the large EU countries of France and Germany. Source: http://www.acompliareport.com...;
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