Safety of new weight-loss drug is questioned
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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
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_drugThe marketers of alli, a GlaxoSmithKline manufactured drug, will provide consumers with the first Food and Drug Administration (FDA)-approved over-the-counter weight loss product without a prescription as it hits store shelves this summer (2007).
However, first they are debuting the "diet pill" with an exhibit in New York City to educate the public about their product, which is being touted as a safe and effective drug that won FDA approval in February.
This product is for any adult who is overweight. However, the manufacturer and its marketing company are taking a different approach than that of the drug, Xenical, which has twice the potency of alli.
First, the educational promotions are being forthright with information, such as the facts that there is no "magic" diet pill, and that people who use alli must also make a concerted effort to eat a reduced-calorie, low-fat diet, and exercise regularly.
If these efforts are made while using the drug that manufacturer's claim only affects the gastrointestinal system, then results will be seen.
The FDA noted that people using alli lost an additional two to three pounds for every five pounds that were lost by dieting and exercising.
According to the manufacturer, "alli helps people lose 50 percent more weight than with diet alone."
When alli is taken along with meals, the effective process blocks absorption of nearly one-quarter of the fats consumed (approximately 150 to 200 calories), which are then passed right out of the body.
However, this affect can result in loose bowels. Nearly 50 percent of trial study participants experienced gastrointestinal side effects (including bowel leakage and oily discharges) with the use of alli.
In fact, these unpleasant side effects are why the company is stating how important it is to use the drug properly and count fat gram intake.
In addition, the educational literature even recommends that users of the product should really start the program in conjunction with time off from work.
The drug includes a "starter kit," a food journal, a healthy eating guide, a fat and calorie reference guide, and 60 capsules of alli. The recommended dosage is one to three pills per day. A total of 60 capsules will cost about $50, whereas 90 capsules will cost about $60.
Since the late 1980s, adult obesity has steadily increased in this country, according to the FDA that began to formulate a plan to tackle the problem.
Currently, two out of every three people in the U.S. are considered overweight or obese, according to an AP report
Source: http://www.allheadlinenews.com/articles/7007429094
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