Weight Loss Drugs - weight loss information

The European Medicines Agency has warned consumers that the weight loss drug Acomplia heightens the risk of suicide among those taking anti-depressants.

The agency wants stronger warnings placed on the drug to reflect that risk but has stopped short of suspending the drug.

The agency says though the benefits of Acomplia outweigh its risks, it should not be used under any circumstances in patients with ongoing major depression or those who are taking antidepressants.

The panel has also called for a new warning on Acomplia's label to state that treatment should be stopped if a patient develops depression.

Information regarding the updated information will be sent to all doctors as the agency says it is important patients and their carers are aware of the risk of depression with the drug.

The move is in line with that of an advisory panel to the Food and Drug Administration (FDA) in the U.S. which has said the product should not be approved because it may increase suicidal thinking and depression.

The FDA decision was the result of a study which found that of 120 patients taking the drug, two had committed suicide and one was considering it, while another attempted to strangle his daughter.

Since that decision drug company Sanofi has withdrawn its application to sell Acomplia in the United States; it has been available under the brand name Zimulti in Europe since the middle of last year.

European officials are likely to allow the drug to remain on the market but with stricter warnings.

Acomplia is the first in a new class of drugs that work by switching off the same brain circuits that make people hungry when they smoke cannabis and it was forecast to become a multibillion dollar blockbuster.

More than 40,000 Britons have been treated with Acomplia since last year which was lauded as a wonder drug after trials showed it could help dieters lose up to 10 per cent of their body weight and also help smokers quit.

The Medicines and Healthcare Products Regulatory Agency in the UK says to date there have been 318 cases of patients being adversely affected by Acomplia.

Source: http://www.news-medical.net/?id=27891

A new over-the-counter weight-loss drug called Alli may give people with eating disorders another tool to harm themselves, local therapists fear.

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With obesity on the rise in America, and the lengthy list of medical issues attributed to it, consumers are searching for ways to lose weight. Nothing represents America's desire to lose weight more than the billions of dollars spent each year on weight loss programs.

Unfortunately though, those trying the newest fad diet or diet pill quickly find the money spent doesn't pay off.

Alli is the most recent diet pill to hit the market. Made by the same manufacturer of the prescription diet drug Xenical, Alli is a lower dosage version and can be purchased over-the-counter.

Just like Xenical, Alli is promoted as a weight-loss enhancer by preventing the absorption of fat from foods we eat. And just like its predecessor, Alli does increase the risk of becoming deficient of fat soluble vitamins. Therefore, taking a daily multi-vitamin at a different time than taking Alli is a must.

Alli's manufacturer recommends using the pill in conjunction with making lifestyle changes. These changes include exercising and eating a low-calorie, fat-controlled diet. Since Alli is a fat blocker, the manufacturer recommends eating no more than 15 grams of fat at each meal, or a consumer runs the risk of having negative symptoms (i.e.: gas, loose stools, diarrhea, and more frequent and/or hard to control bowel movements).

Fifteen grams of fat per meal equates to eating 25 percent of one's daily calories from fat when following an 1,800 calorie meal plan (or three meals with 15 grams of fat and one snack with 5 grams of fat). Fat should provide 20 to 35 percent of our daily calories, according to the 2005 U.S. Department of Agriculture dietary guidelines.

Does it work?

Weight loss may occur, but not necessarily in the amount you are hoping. According to Dr. Donald Hensrud, of the Mayo Clinic in Rochester, Minn., although some studies have been done on Alli, most of the weight loss projections are based upon the results of studies done with Xenical. With Xenical creating an average weight loss of only 6 pounds each year above weight loss from diet and exercise, he concludes at "half the strength, Alli could conceivably result in an average of 3 pounds lost in a year."

In the end, I feel the potential positives associated with the use of Alli are heavily outweighed by the negatives. Therefore, I recommend customers save their money and not use this diet aid.

Source: http://www.masslive.com/

A new over-the-counter weight-loss pill, which has been disappearing quickly from store shelves across Houston since it became available a week ago, is likely to cause undesirable side effects if dieters don't also abide by the low-fat diet that the drugmaker recommends.

That hasn't stopped thousands of people from flocking to pharmacies to buy Alli, the first FDA-approved nonprescription diet drug. For the past week, pharmacy employees have stocked and restocked their shelves with the pills.

"We can't keep up with it," said Hisham Ghali, executive assistant manager of a Walgreens in River Oaks.

The store had sold out of the largest available bottle of Alli on Thursday, but he expected another shipment within a few days.

Alli, pronounced "AL-eye" and manufactured by GlaxoSmithKline, prevents the body from absorbing fat by blocking enzymes in the digestive system. Made using orlistat, which has been available for several years in a higher-dose prescription form called Xenical, Alli blocks about a quarter of the fat eaten during a meal when users pop a pill beforehand. It can be taken up to three times daily.

Users of Alli can lose about 50 percent more weight than they would through dieting alone, according to GlaxoSmithKline. For example, someone who loses 10 pounds through dieting could lose 15 pounds with Alli, the company says.

The drug can cause nasty side effects, however, particularly for dieters whose fat intake per meal is higher than the recommended 15 grams. (A fast-food hamburger can contain 30 grams.) GlaxoSmithKline warns of the potential for "gas with oily spotting, loose stools or more frequent stools that may be hard to control." The company suggests not taking the pill before meals with high fat content.

Users attest to this on Alli's online message board through posts called "accident support group." Some complain of the bowel changes and leaks consistent with GlaxoSmithKline's warnings, while others say they have constipation or cramping. Meanwhile, dieters considering using the drug ask questions such as, "adult diapers mandatory during first week?"

For at least one Alli dieter, the unpleasant side effects are part of the drug's appeal.

"It forces me to diet and exercise to avoid any bad side effects," a dieter who signed in as Sheree wrote on Alli's message boards. "Trust me, on my own I would have already cheated!"

Low-fat diet is crucial

Two local diet specialists said orlistat can be effective, so long as the user is dedicated to a low-fat diet.

"For the person who's committed to eating right and exercising and doing the right things, then staying on Alli will serve them well over time," said Dr. Tom Lux, assistant professor of internal medicine at the University of Texas Medical School at Houston, who has prescribed Xenical for weight-loss patients. "For a person who likes to eat a lot of steak and heavy food and fried food, it's not going to be a good choice."

After a Walgreens in the Memorial area got its first shipment on June 14, buyers bought all 36 packs of 90 pills, at a price of $59.99, that day. The store got a shipment of 60- and 120-pill packs the following day and quickly sold those, too, said store manager Bill Coligan.

"It was a little busy," he said. "Every couple of minutes, we were over here unlocking the case."

'Not a magic pill'

Stores are keeping the product locked because it's so popular, and pricey, that it's a major target for shoplifters who want to sell it on the street. A 60-pill "starter pack" sells for $49.99, while one with 120 pills goes for $69.99.

The drug also is selling well at other local pharmacies, including CVS and Kroger.

Rebecca Reeves, a dietician and assistant professor at Baylor College of Medicine who has conducted research on orlistat, said having the drug available over the counter provides a great opportunity for people looking to lose weight.

"It's not a magic pill," she said. "It will help you along when you are involved in a good, healthy lifestyle."

Source: http://www.chron.com/disp/story.mpl/front/4914080.html

The first non-prescription diet drug ever to be approved by the FDA hit the shops this week and optimistic dieters are dashing out to buy it.

The new diet pill, Alli which is manufactured by GlaxoSmithKline (GSK) works by blocking the absorption of fat by the body which is then eliminated by way of the bowels.

The drug does have some unpleasant side-effects such as oily bowel movements, loose stools and the possibility of leakage, along with gas.

A months supply of Alli will set you back US$60 and GSK recommends the best results will be achieved when no more than 15 grams of fat per meal are eaten while taking the drug.

Alli is not recommended for people younger than 18, people with kidney disease, or people on blood thinners.

In a study, Alli taken in conjunction with a good diet, offered an additional 5% of weight loss when compared to somebody following a good diet without taking the drug.

Only 20% of people who use Alli can expect to lose 10% or more of their body weight and many will lose very little weight and possibly suffer the embarrassing gastrointestinal side effects.

Unlike other prescription weight-loss drugs Alli does not induce a feeling of fullness, reduce cravings or curb the appetite; what it does do is prevent the body from breaking down and absorbing fat.

The active ingredient in Alli, orlistat is also found in the prescription diet drug Xenical but in a higher dosage.

While Alli blocks around 25% of the fat eaten, Xenical blocks one-third of the fat ingested.

In real terms 2,000 calories a day with about 30% fat, would translate to about 150 calories a day with Alli.

A pound of weight loss equates to 3,500 calories.

Limiting fat intake to 15 grams a meal will help avoid the side-effects - .most Americans consume 80 to 100 grams of fat a day.

Glaxo officials do admit that many people would lose weight on their own with a reduction in fat intake, but say that Alli helps people lose more weight.

Doctors say most people are eating far more fat than they realize and the case with most dieters is that are unable to sustain the weight loss.

Orlistat has been widely tested and about 50% of the people who use orlistat lose at least 5% of their body weight; only one out of five people who take the drug lose at least 10% of their body weight, according to Glaxo.

Experts say even small amounts of weight loss offer health benefits.

Source: http://www.news-medical.net/?id=26566

The new weight loss drug Alli is about to hit the U.S. market.

Alli which is produced by GlaxoSmithKline will be available to consumers in America next week following a 150 million dollar advertising campaign to promote the non-prescription drug.

Alli will be the only non-prescription drug marketed as a weight loss remedy that has the approval of the Food and Drug Administration.

The drug works by reducing the amount of fat that is absorbed by the body; the undigested fat is eliminated in bowel movements, which can cause side effects such as gas and oily discharge.

Alli is a half-dose version of the Roche prescription drug Xenical which also works by reducing the amount of fat the body absorbs from food.

It will cost between $55 and $60 for a month's supply, just over 60 cents per tablet, based on a regimen of three pills a day.

Alli is good news for GSK who are still recovering from the safety scare over it's diabetes drug Avandia.

GSK hopes the product will be available in Europe, under a different name, in 2008 and are also planning to submit Alli for regulatory approval in Canada, Latin America, China, Australia and New Zealand before the end of 2007.

Glaxo is stressing in their advertisements that Alli is no "magic bullet" and requires commitment to a low-fat diet.

It will compete with multiple OTC supplements that claim weight-loss benefits but have not been cleared by the FDA.

Source: http://www.news-medical.net/?id=26221

GLAXOSMITHKLINE (GSK) CONSUMER HEALTHCARE HAS launched the first salvo of its $150 million effort for Alli, the first FDA-approved over-the-counter weight loss drug in years. The effort for Alli (pronounced like ally) launched on May 22 in New York City. The company took over the vaulted-ceiling main room of 20 Union Square for its multimedia exhibit called Alli Experience.

The central tenet of the experience--and of the drug, which goes on sale mid-June--is gradual weight loss and a "don't expect miracles" approach embodied by the tag, "Your will. Our power."

The compound, an attenuated version of prescription drug Xenical (Orlistat 120mg), works by inhibiting the function of intestinal enzymes that facilitate the body's absorption of fat. The company says it blocks the absorption of about a quarter of the fat one consumes. GSK will sell Alli in product packets that include a 30-day supply and a series of books including calorie counters, diets and recipes, lifestyle tips, and a diary.

Since the compound--intended to be taken three times daily--is being pitched as a companion to dieting rather than a replacement for it, the company's marketing and the exhibit attack fad and crash diets and repeat, in different forms, the mantra that dieting is a commitment that takes time, pill or no pill.

The first area of the exhibit is a passage flanked by video screens playing clips of miracle diet ads and stories debunking them, while speakers play a cacophonous loop of quick-diet pitches.

The next space is a bench next to a wall of sayings like "there are no shortcuts." There's an interactive section featuring tables with Mac computers letting one view content on how Alli works, on dieting, etc., and there are areas featuring examples of various dishes and snacks--some healthier than others--with big turntables showing real food under glass and their respective caloric and fat content.

A dietitian and pharmacist are also on hand. Visitors leave with a shopping bag of brochures, games, surveys and a book, Are you Losing It? The book is for sale in pharmacies and bookstores for $5.99, the proceeds going to child obesity charities.

Joe Cadle, Marketing Director/Weight Control of GSK Consumer Healthcare, says that although GSK positions the treatment in contradistinction to compounds claiming to "melt off the pounds," the competition is not miracle drugs--because, he says, people who reach for quick and easy solutions to weight problems won't be interested in Alli. "People who tend to buy miracle drugs are looking for a quick fix, so we aren't competing with them. Our efforts are positioned against those selling to consumers committed to doing the hard work."

Says Cadle: "When you take a look at the messages out right now, a lot of products are being marketed as miracle fixes: 'Lose 20 pounds in two weeks!' Alli is about changes toward a healthy lifestyle that require a commitment."

Cadle says the marketing group realized, through consumer research, that consumers have no clue what the difference is between an FDA-approved compound and any number of so-called diet drugs lining shelves and being promoted in ads. "People intuitively don't trust these things any more--they hear these claims, and know they are not true. We want to be an honest voice in a category known for hype. The truth is, losing weight is hard ... and that resonates." He explained that Alli is intended to offer a kind of bonus for the work of dieting via extra "bonus" weight lost. "One woman in a focus group says those extra five pounds would be priceless."

Debbie Weis, GSK Consumer Healthcare senior brand manager, says that, depending on the response to the Alli Experience in New York, which ended last week, the company plans to have additional programs in other markets.

One of the staff pharmacists says as many as 1,300 people have come through on a given day, with many of them asking questions about the effect of Alli on diabetes and cholesterol-lowering drugs. Cadle says GSK is doing targeted efforts via sales teams and targeted communications to physicians on specific health issues.

Overall, per Weis, about 5,000 people have come through the exhibit since the opening. "They are spending around 10 minutes in the space, on average. That's more than we expected."

The company began running a "drive-to-web" 30-second TV spot earlier this month, and Cadle says that the Alli Web site, myAlli.com, has garnered 1 million unique visitors since launch.

Per Cadle, this month GSK will launch a 60-second TV commercial and will ramp up Internet efforts. Print efforts will include 15 million four-page inserts in July and August issues of women's magazines with an "accordion-fold" pull-out.

"From a marketing perspective, we are developing content that can travel, content you can carry--we want to educate consumers at every possible touch point [about] where they can find Alli," he says.

Display kiosks at pharmacies and stores selling Alli will be focused less on product pitch than education and self-inquiry about will power, Cadle says--with brochures on lifestyle and diet choices, assessment tests, even a telephone at some retail points that have audio challenging consumers to think about whether they are willing to make the commitment. The company is also running video content on YouTube.

Consumers can purchase the Alli starter kit for $49.25 for a 60 capsule-count starter pack and for $62.99 for a 90-capsule starter pack, per a GSK spokesperson. However, the retail cost of the product in stores may vary a little based on the individual retailer promotional plans.

Source: http://publications.mediapost.com/

The FDA is set to release results of their review of a weight loss pill called Acomplia which is manufactured by French drug maker Sanofi-Aventis.

The FDA is getting set to release results of their review of a new weight loss drug that is already approved for use in Europe.

Acomplia is the name of the drug which is manufactured by Sanofi-Aventis and on Wednesday of this week, an expert advisory panel is set to meet to discuss the drug.

"With the initial demand for Acomplia likely to be massive, the known neuropsychiatric side effects may make it difficult for the FDA to see a positive risk-benefit ratio," wrote Citigroup analyst Kevin Wilson in a Thursday note.

The decision handed down by the advisory panel may have a big impact on the FDA's final decision. Although they do not have to agree with their expert advisory panels, they often do.

Studies of the Acomplia drug have reported some symptoms such as depression, insomnia and anxiety in patients who take it, thus whether or not the drug will be approved by the FDA is anybody's guess.

Last February, the FDA denied Sanofi's application for their drug to be used as an anti-smoking pill stating that they needed more information before approving it.

Source: http://www.dogflu.ca/06102007/21/fda_reviewing_acomplia_drug

Sanofi-Aventis investors should brace for trading volatility next week when U.S. regulators reveal their review of the company's highly anticipated weight loss drug.

The French pharmaceutical company seeks Food and Drug Administration approval of Acomplia, a drug approved in Europe for fighting obesity.

The FDA is set to release its Acomplia review ahead of a Wednesday meeting at which outside experts will vote on whether it should be approved. The agency does not have to follow the experts' vote, though it often does.

The drug is considered a potential blockbuster despite hitting several regulatory bumps that have left some on Wall Street questioning its sales prospects.

"With the initial demand for Acomplia likely to be massive, the known neuropsychiatric side effects may make it difficult for the FDA to see a positive risk-benefit ratio," wrote Citigroup analyst Kevin Wilson in a Thursday note.

In recent weeks, the FDA has been widely criticized over a lag in getting new safety data about a GlaxoSmithKline diabetes drug to the public.

Analysts say that controversy might give regulators pause at approving a new drug with potentially dangerous side effects. Studies of Acomplia have shown instances of depression, insomnia and anxiety in patients who take it.

Wilson predicts that the FDA's review of the drug will likely focus more on safety than effectiveness, driving Sanofi's stock down in the first part of the week.

Sanofi originally touted Acomplia as both an anti-obesity pill and an anti-smoking treatment because it stops cravings associated with addictive behavior.

Last February, however, the FDA rejected the company's application for the anti-smoking use and said it needed more information before approving the drug to fight obesity.

The drug gained approval in the European Union soon after, but regulators there also did not approve the smoking use and limited approval to overweight patients who suffer additional health problems, including abnormal cholesterol and diabetes.

Even so, sales there soared to $20 million in the first quarter of 2007, and Sanofi said more than 130,000 people have used the drug since its European launch.

If approved in the U.S., Sanofi said it would market the drug under the name Zimulti, because FDA reviewers felt the name Acomplia could potentially mislead consumers.

Shares of Sanofi-Aventis rose 5 cents to $45.28 Friday in midday trading.

Source: http://www.chron.com/disp/story.mpl/ap/fn/4873677.html