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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...;

 

 

 
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/ ;

 
Diet Drug Acomplia (Rimonabant) Users in Germany Get Bad News on Reimbursement
06.20.07 (11:22 pm)   [edit]

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...;

 
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...;

 
UPDATE: FDA Sees Problems With Sanofi Diet Drug Acomplia
06.11.07 (10:26 pm)   [edit]
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/ ;

 
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...;

 
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...;

 
Get Slimmer, Fitter and Confident with “Acomplia”
06.01.07 (9:59 pm)   [edit]

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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