Updates : Announcements

New Statement from GSK to address alli and Liver Disease Concerns

The alli Team — Wed, 02 Sep 2009 15:09:00 GMT

The following is an updated GlaxoSmithKline Consumer Healthcare statement in response to the FDA’s Early Communication about the safety review of Orlistat:

On August 24th the FDA reported that it is continuing its safety review of orlistat and liver-related serious adverse events.

It’s important consumers know that alli is safe and effective and there’s no evidence to suggest alli causes liver injury. In fact, the FDA has said that consumers should continue to use alli as directed.

http://www.prnewswire.com/mnr/alli/39949/

Because orlistat is minimally absorbed in the blood and works locally in the gastro-intestinal tract, there is no obvious biological mechanism to suggest liver injury can occur with alli.

To put FDA’s communication into perspective, there is a high prevalence of liver disease in people who are overweight. It is estimated that about 15-20% of obese people have liver injury due to excessive fat in the liver. [1] Additionally, in obese individuals, gradual weight loss can prevent injury or improve liver function.

The August 24th communication is part of FDA’s current process of sharing information directly with consumers and healthcare professional related to the safety monitoring of marketed drug products. This does not mean that FDA has concluded that there is a risk.

Since orlistat first became available as a prescription medicine in 1998, more than 40 million people have used the drug. Of these, more than 6 million have used alli, the only FDA-approved over-the-counter weight loss product. The FDA identified two reports out of the six million consumers who have used alli since its approval in 2007.

Orlistat, the active ingredient in alli, is the most-studied weight loss medicine. Its safety has been established through 100 clinical studies involving more than 30,000 patients.

GSK continues to proactively monitor the safety of orlistat and share all relevant information with regulatory agencies. Based on our comprehensive review of the safety data from preclinical, clinical, post-marketing safety surveillance, published literature as well as epidemiology data, we conclude that the data do not suggest that orlistat is causally related to liver injury.

We are actively working with the FDA to better understand the reports it has received. If you have concerns, you should talk to your doctor or pharmacist. For more information on the safety and efficacy of alli, please visit http://www.myalli.com/ and/or call 1-800-671-2554.

FOR ACCESS TO EXPERT COMMENT:
Malesia Dunn
malesia.a.dunn@gsk.com
412-200-3544

Mechal Weiss
mechal.weiss@edelman.com
212-642-7731
917-952-4807

[1] Preiss, D., Sattar, N. Non-alcoholic fatty liver disease: An overview of prevalence, diagnosis, pathogenesis and treatment considerations. (2008) Clinical Science, 115 (5-6), pp. 141-150.

alli statement on FDA hepatotoxicity issues

The alli Team — Wed, 26 Aug 2009 20:30:00 GMT

GSK stands firmly behind the safety and efficacy of alli. Our primary priority is patient health, and we want people to know that there is no evidence that alli causes liver damage.

The FDA is reviewing data from suspected cases on liver injury associated with the use of orlistat/alli. Any routine assessment from a regulatory body does not mean that a risk or causal relationship exists.

alli is a 'non-systemically' acting medicine - it is minimally absorbed in the blood and works locally in the gastro-intestinal tract. There is therefore no obvious biological mechanism to suggest liver damage can occur with alli.

Liver changes can have many causes. People who are overweight and obese are predisposed to liver-related disorders.

The safety of consumers is of utmost importance to GSK. We continually monitor and evaluate reports of adverse effects associated with use of all of our products, including alli.

GSK regularly communicates with independent regulatory bodies and provides them with comprehensive safety data on our products. Orlistat, the active ingredient in alli, is the most-studied weight loss medicine, with safety established through 100 clinical studies involving more than 30 thousand patients.

myalliplan introduces new meal and activity plan features

The alli Team — Thu, 18 Dec 2008 18:21:00 GMT

By purchasing alli and registering as a member of myalliplan, you receive customized tools to help you reach your weight-loss goals. We are excited to announce that we have enhanced these tools to help you achieve and maintain healthy weight loss. These updates include:

a combined meal plan and nutrition log to make entering your daily food intake quick and easy
cooking videos that demonstrate how to make easy and delicious alli-friendly meals
a food analyzer to look up nutritional information of your favorite foods
an updated water intake log
new activity videos that demonstrate simple and easy-to-follow exercise plans (your very own personal trainer!)

So if you're already a member of myalliplan, check out the new tools now.

If you're not you can register for myalliplan here.

alli proudly supports Breast Cancer Network of Strength

The alli Team — Fri, 29 Aug 2008 18:16:00 GMT

In honor of National Breast Cancer Awareness Month in October, alli has become a sponsor of Breast Cancer Network of Strength, to promote the power of encouraging words between survivors and those whose lives have been touched by breast cancer.

learn more about Breast Cancer Network of Strength

alli has made a $150,000 contribution to Breast Cancer Network of Strength. Breast Cancer Network of Strength name and emblem are used with its permission which in no way constitutes an endorsement, express or implied, of this product.

get the truth about alli and save $10

The alli Team — Tue, 05 Aug 2008 16:38:00 GMT

Don't let misinformation stop you from reaching your weight loss goals.
Read all about the myths, the facts and the realities of alli and save $10.

learn more now

introducing allicircles: a new community of support

The alli Team — Thu, 10 Jul 2008 20:26:00 GMT

We are excited to announce the new alli community, allicircles. It's now the home of the alli message boards and real allistories- but even more, allicircles is a place to:

create a profile
find people you can relate to
build a circle of friends

Weight loss is a journey that isn't always easy, but with allicircles, you can find the support you're looking for. So come help the allicircles community thrive. Share. Learn. Inspire. Your voice is welcome here.

explore allicircles

eat well on your way to weight loss with alli – introducing the alli Cookbook with Restaurant Guide

The alli Team — Wed, 09 Apr 2008 14:49:00 GMT

The alli Cookbook is full of delicious choices to make meal time more enjoyable and fits the nutrition guidelines recommended for use with the alli program. Included in the book are:

* Over 200 recipes for main dishes, sides and desserts – many with color photos;
* Meal plans to help make weekly meals easy;
* Special menus and recipes for year-round celebrations;
* Detailed nutrition information for each complete meal

And for nights you want a break from eating in, the alli Cookbook also includes a tear-out restaurant guide to great establishments such as Applebee’s, Panera Bread Company, Starbucks, Pizza Hut and PF Chang’s just to name a few. Plus great tips on how to order “alli-friendly” food at your favorite eatery.

Buy now on amazon.com

check out our new health and fitness videos

The alli Team — Mon, 07 Apr 2008 15:14:00 GMT

Ready to get fit for the summer? Let us help with our new videos from health and fitness experts.Take a moment to browse through them now and learn techniques for working out at home, getting results at the gym, and preparing a delicious meal for dinner tonight. And make sure to check back often for new additions!

view videos

eDiets to deliver delicious, alli-friendly, freshly prepared meals

The alli Team — Mon, 07 Apr 2008 15:07:00 GMT

alli® users can now receive great-tasting food at their doorsteps through freshly prepared meals from alli & eDiets. eDiets is rated #1 for taste and nutrition*. And with several meal selections for breakfast, lunch, dinner, and snacks, alli users can follow a reduced-calorie, low-fat diet with no prepping and no cooking.

*rated #1 by epicurious.com for best taste and nutrition in a survey of five popular brands.
Learn more

Learn more about freshly prepared meals from alli

watch the new alli TV commercial - "do i really need alli?"

The alli Team — Fri, 26 Oct 2007 21:19:00 GMT

find out how alli can help you lose more weight than diet and exercise alone

2 million people partner with alli

The alli Team — Wed, 24 Oct 2007 21:14:00 GMT

Pittsburgh (October 23, 2007) – GlaxoSmithKline Consumer Healthcare (NYSE: GSK) announced today that it has sold more than 2 million alli starter packs at retail, and that alli users are enthusiastically embracing alli and its proven track record of helping people lose weight gradually. This news comes as the company is breaking the first in a series of next-generation ads for the weight-loss product that depart from the typical “before and after” testimonials and offer an intimate and honest look at the healthy diet and lifestyle changes experienced by actual alli users.

Launched nationwide on June 15, alli is the only FDA-approved weight-loss product available to overweight adults without a prescription. The alli capsule works by blocking the absorption of about 25 percent of the fat in the foods people eat, helping them lose 50 percent more weight than they would through diet and exercise alone. alli starter packs contain alli capsules in 60, 90 or 150 counts, plus user’s guides, dietary support materials, access to a free online support program and the alli “shuttle™” carrying case.

In addition to its retail success, alli is garnering intense consumer interest and discussion. Approximately 5.4 million unique visitors have logged on to the alli websites, myalli.com and the Spanish-language mialli.com. In addition, more than 200,000 people have enrolled in alli’s online behavioral support program. Consumers have also posted more than 125,000 messages on the official alli message boards, and tens of thousands are talking about alli on blogs and online discussion groups they have formed themselves.

New Ad Campaign Breaks October 23
The new alli advertising campaign, which breaks today, is unique in that the users featured do not define success simply as pounds lost. They individually share that the alli program has been a life-changing experience, helping them improve their eating habits and making them feel more in control of their weight.

“It’s really been a lifestyle change for me,” says one alli user featured in the campaign. “From the moment you take that first capsule, it’s a different way of thinking. Here I am two months later, I’ve lost 15 pounds and I’m thrilled.” Another user states, “The support that I’ve received is phenomenal. At first, I didn’t think the program would be easy to manage, but it’s very doable. alli has convinced me that eating healthy is a way of life.”

Steven Burton, GSK Consumer Healthcare vice president of weight control, notes that, “From the very beginning, alli set out to be an honest voice in the weight-loss category. These are actual users who talk about everything from initially having questions about alli to how they now look at weight loss in entirely new ways.”

alli’s advertising agency, Arnold Worldwide, recruited close to 100 users from the alli “First Team,” a group of early adopters from across the country who were given access to the product a few months before it hit store shelves. The agency asked for videos of their stories, and ultimately flew seven of the team members to New York to film them.

Arnold produced seven, two- to three-minute vignettes of the alli users, some of which will be used to produce :30 television commercials. All seven stories will appear in their entirety on the alli website, where several other stories submitted by alli users from across the country already reside.

Arnold Worldwide Group Creative Director, Kate Murphy, acknowledges that people want to learn about products through the experiences of real people to whom they can relate.

“Consumers today want to hear that a product works from other real people,” she says. “It’s one thing for a manufacturer to say its product is effective, but getting that information from an actual user with actual experiences to share is much more powerful.”

picture this: the alli Experience on the move

The alli Team — Mon, 01 Oct 2007 18:34:00 GMT

Passers-by stopped to receive free weight loss and nutritional advice from registered dieticians at the alli Experience exhibit at Roosevelt Field mall in Garden City, N.Y., recently. Sponsored by GlaxoSmithKline Consumer Healthcare, the exhibit will make stops in 12 U.S. cities this fall, helping overweight adults learn about healthy, realistic weight-loss approaches.

get straight talk about weight loss at a mall near you

The alli Team — Tue, 25 Sep 2007 13:47:00 GMT

If fad diets worked, we’d all be thin. Don’t miss the alli® Experience, an interactive exhibit that showcases a revolutionary new approach to weight loss and a healthy lifestyle. Visit this educational experience to hear straight talk about weight loss, get tips on how to make healthy food choices that taste great, and speak with a dietitian. You must be 18 years or older to attend.

Date Location Mall

9/21 – 9/30 Dallas Stonebriar Centre - Dillard's Court

9/21 – 9/30 New York Roosevelt Field - Macy's Court

9/21 – 9/30 St. Louis Saint Louis Galleria - Center Court

10/5 - 10/14 Houston Houston Galleria- TBD

10/5 - 10/14 Minneapolis Mall of America - Sears Court

10/5 - 10/14 Philadelphia King of Prussia Mall - Nordstrom Court

10/19 – 10/28 Detroit Lakeside Mall - Center Court

10/19 – 10/28 Atlanta North Point Mall - Dillard's Court

10/26 - 11/4 Los Angeles Glendale Galleria - JCPenney Court

are you currently using alli™? are you willing to share your story?

The alli Team — Wed, 12 Sep 2007 14:07:00 GMT

The makers of alli, the only FDA approved over-the-counter weight loss product, want to hear from you.

If you are currently using alli, your alli story could help educate others about the alli program and how to adopt a healthier lifestyle and commit to gradual and healthy weight loss.

You and your story may be featured in upcoming alli communications.

If you are interested, please call 1-877-469-2554 (10am-6pm EST) to answer a few brief questions and provide your contact information to be re-contacted by a member of the alli team.

get the answers to common questions

The alli Team — Fri, 20 Jul 2007 20:09:00 GMT

If you have questions about alli, visit our frequently asked questions page. You’ll find insightful answers to questions about alli capsules, myalliplan, and the alli program.