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Senior Citizen Health & Medicine

Alli Hits the Market by Friday Behind Lots of Hype as First OTC Diet Pill

GlaxoSmithKline says alli designed for overweight adults willing to change how they eat and lose weight gradually – users say it works

June 13, 2007 - alli(TM), the only FDA-approved over-the-counter weight loss product will be on shelves of pharmacies, grocery stores and mass merchandisers nationwide by Friday. Adding alli to diet and exercise can help people lose 50 percent more weight than with dieting alone, says the manufacturer. Senior citizens using blood thinners, being treated for diabetes or thyroid disease should, however, consult physician, says the FDA.

 

Related Stories

 
 

Update:

Alli Hits Market Today but May Not Be the Diet Pill to Get Hooked On: Consumer Reports

Offers modest results and can cause embarrassing side effects

June 15, 2007


Does New Over-the-Counter Diet Pill alli Live Up to Its Hype?

OTC strength orlistat works with healthy diet, exercise, study finds

June 13, 2007


Alli Becomes First OTC Diet Pill Approved by FDA

Senior citizens using blood thinners, being treated for diabetes or thyroid disease should consult physician

Feb. 8, 2007 - The FDA yesterday issued its first ever approval for an over-the-counter diet pill – alli, the marketing name for the generic drug orlistat. It is a reduced strength version of the prescription drug Xenical. Senior citizens and others with diabetes, thyroid disease or taking blood thinning medicine should consult with their physician before using it. And, it is only approved for those age 18 and older. Read more...


Read the latest news on Senior Health & Medicine

 

alli is designed to be a partner for overweight adults willing to change how they eat and lose weight gradually. It is being supported by an unprecedented multicultural and bilingual educational effort, making it more than just a pill but a comprehensive weight loss program.

With alli, people will have access to an individualized online action plan with a year's worth of lessons included in each alli purchase, at myalli.com, says GlaxoSmithKline Consumer Healthcare.

"alli is not for people looking for miracle pills and overnight results, the company cautions.

It offers consumers a proven, safe, over-the-counter option to help them lose weight gradually," says Steven L. Burton, vice president, Weight Control, GlaxoSmithKline Consumer Healthcare.

"One of the most rewarding parts of being involved with the alli revolution is the opportunity to have a real impact on the health and lives of people all across this country. We recognize people need help to lose weight and that is why we are so excited that alli is now available to provide adults with the support they need."

alli First Team

In April 2007, GlaxoSmithKline Consumer Healthcare selected 400 overweight women and men to be part of the alli First Team. Members of the alli First team were invited to participate in an online community focused on following the alli program, sharing personal experiences, and supporting other community members to be successful.

For participating in the alli First Team, people received educational materials and tracking tools, access to the online community of alli users and a six-month supply of alli.

These early users are providing honest and candid feedback on their experiences with alli in an effort to help others succeed on the program, the company says.

"In beginning of the alli program, I learned that there are treatment effects, so if you cheat (by eating foods that are high in fat), you will pay the price," says Caryn Eyring, an alli First Team Community member.

"Luckily, I've stayed within the plan so I have not had any treatment effects. However, I pushed the envelope once."

Team members are adults from all across the United States who represent a broad mix of ages, backgrounds and life experiences and are committed to a gradual and healthy approach to losing 10 pounds or more. According to alli First Team Community member Maryann Gatti, "I am so happy that alli is available. It is giving me the advantage to succeed at losing weight. I needed that extra little something to help me, because for those of us who aren't as young as we once were, and don't burn calories as well as we use to, dieting can seem hopeless. alli is working for me."

The Program

GlaxoSmithKline Consumer Healthcare has developed innovative tools to help consumers achieve success with the alli program. People can find educational materials where alli is sold that can help overweight adults decide if they are ready for alli.

alli comes in a variety of sizes - the 60 capsule and 90 capsule educational starter packs or a 120 capsule refill pack and is priced at approximately 60 cents a capsule or $1.80 per day. The recommended dose is one 60mg orlistat (the active ingredient in alli) capsule, three times a day, with meals containing fat. alli starter packs include:

  - Read Me First Guide
  - Welcome and Companion Guides
  - Guide to Healthy Eating
  - Daily Journal
  - Calorie and Fat Counter
  - Quick Facts Cards
  - Free access to an individualized online action plan at myalli.com
  - Convenient capsule carrying case called the Shuttle(TM) that easily fits into a purse or pocket.

The centerpiece of the alli program - myalliplan -- is an individually tailored online action plan. The alli plan was developed by nutritional and weight management experts who understand the struggle to lose weight. After purchasing alli, people can access this innovative support program 24 hours a day. myalliplan includes:

  ● Customized online action plan

  ● Recipes, meal plans and shopping lists

  ● Online tools to record food and lifestyle information

  ● Connection to a network of other alli users

  ● Personalized e-mails that deliver lessons about: meal planning, managing hunger, dealing with setbacks, and making the food and lifestyle changes to help people succeed

alli works by blocking about 25 percent of fat in the foods eaten which reduces the amount of fat and calories absorbed. alli must be used in conjunction with a reduced-calorie, low-fat diet. People in studies who adhered to the diet reported satisfaction with the product and weight loss results. By sticking to a low-fat diet many were able to manage bowel changes or "treatment effects" (such as having an urgent need to go to the bathroom).

Many did not experience treatment effects at all. The program teaches adults which foods to eat and which foods to avoid for weight loss success and a healthier lifestyle overall.

Gary Foster, Ph.D, director for the Center for Obesity Research and professor at the Temple University School of Medicine, and one of the consulting experts who helped develop the online plan says, "We welcome the addition of the alli program as an easily accessible, safe and effective option in the war against overweight and obesity. It's time we set the record straight - losing weight requires lifestyle changes. To get people started, we must provide them with the tools to be successful, and the alli program does that."

Safety Profile

 

FDA Information

 
 

>> FDA Center for Drug Evaluation and Research information on Orlistate OTC (marketed as alli) - Click Here

>> View the information label (pdf) - Click Here

 

Orlistat (the active ingredient in alli) has been used by millions of people worldwide. Its safety and efficacy are well established. According to Vidhu Bansal, Pharm.D., director, Medical Affairs, GlaxoSmithKline Consumer Healthcare, "With a raging overweight and obesity epidemic, alli offers consumers a proven, safe option to help them lose weight without a prescription.

Unlike the herbal and dietary supplements for weight loss on the market, alli is an FDA-approved over the counter weight loss product." Bansal adds, "alli works in the gut; it is non-systemic, which means it is not absorbed into the bloodstream. That means alli does not affect the heart or brain or cause sleeplessness, jitters or an increased heart rate."

For more information about alli and the alli program, go to www.myalli.com. People can also find a new book "are you losing it? losing weight without losing your mind," wherever alli is sold. The book delivers straight talk about healthy weight loss strategies and offers a sensible approach to losing weight. Support materials and the online action plan are also available in Spanish at www.mialli.com.

Editor’s Notes:

About alli(TM)

alli is the only FDA-approved weight-loss product available to overweight adults, 18 years or older, without a prescription. It combines a clinically- proven product with a comprehensive individualized action plan. The alli program encourages modest, gradual weight loss, known by experts as the best way to lose weight. alli (60 mg orlistat capsules) is safe and effective when used as directed.

About GlaxoSmithKline Consumer Healthcare

GlaxoSmithKline Consumer Healthcare is one of the world's largest over- the-counter consumer healthcare products companies. Its more than 30 well- known brands include the leading smoking cessation products, Nicorette(R), NicoDerm(R) CQ and Commit(R) as well as many medicine cabinet staples, including Abreva(R), Aquafresh(R), Sensodyne,(R) Tums(R) and Breathe Right(R).

About GlaxoSmithKline

GlaxoSmithKline -- one of the world's leading research-based pharmaceutical and healthcare companies -- is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit: http://www.gsk.com/.

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