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Senior Citizen Health & Medicine
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.
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Story Updates
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
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
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
Senior Citizens Face Double Whammy When It Comes to
Body Fat
Aging, obesity results in bigger body, less
lean mass among elderly
Feb.
7, 2007 - When it comes to body fat, today's older adults face a double
whammy, according to new research from Wake Forest University School of
Medicine and colleagues. Up until age 80, older adults not only gain fat
as they age -- but because of the obesity epidemic -- they actually
begin their older years fatter. The result is an increased risk of
diabetes, heart disease, high blood pressure, arthritis and
disability...Read
more...
Weight-Loss Drug Orlistat Soon may be Sold
Over-the-Counter
No magic bullet – weight loss of about 5% comes
with low fat diet
Jan. 24, 2006 – Millions of senior citizens will
join millions of others today in rejoicing at the news that a committee
of the U.S. Food and Drug Administration has recommended approval of a
popular prescription diet pill for over-the-counter distribution. Before
the cheering gets too loud, however, seniors must realize that Orlistat
(tetrahydrolipstatin) – the prescription versions is Xenical - is not a
magic bullet and it only works with lifestyle changes. Generally, the
weight loss success has been a reduction of about 5 percent.
Read more...
Red Wine Element Reverses Pathways of Obesity
That Cause Age-Related Diseases
Resveratrol
previously found to extend lifespan of other organisms may help against
heart disease, diabetes
November 2, 2006 – The headlines on a new study
focused on the discovery that resveratrol, found in red wine, when given
to obese mice significantly increased their lifespan. Too often obesity
is associated with physical appearance, but this test did not make the
thinner - it helped them live longer. These
researchers emphasize that the drug reversed gene expression
patterns associated with diabetes, heart disease and other diseases
related to obesity. Resveratrol has previously been shown to extend the
life of several other organisms.
Read more...
Waist-Hip Ratio Better Measure of Death Risk for
Older People Than BMI
Study finds Body Mass Index not the best indicator
of mortality
August 8, 2006 - Older people with high waist-hip
ratios (WHRs) have a higher mortality risk than those with a high body
mass index, or BMI, a new study reveals. This sheds further light on the
controversial reports about obesity in the elderly and its relationship
as a cause of death. Waist Hip Ratio is calculated by dividing your
waist measurement by your hip measurement. (Read more about WHR below
news story.) Read
more...
Read the latest news on Senior
Health & Medicine |
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It is also only approved for use by overweight
adults in conjunction with a reduced-calorie, low-fat diet, "alli helps
people lose 50 percent more weight than with diet alone," according to
GlaxoSmithKline Consumer Healthcare, the marketer. The FDA says exercise
should also be part of the program.
Alli is expected to be available in stores
nationwide by summer and the price, not yet final, is projected to be
less than two dollars per day. The recommended dose of alli is one 60 mg
capsule three times a day with meals containing fat.
Taken at meal-time, alli works by blocking about 25
percent of the fat in the food a person eats.
Because of the way it works, alli must be used in
conjunction with a reduced-calorie, low-fat diet containing about 15
grams of fat per meal. The guides and information supplied in the alli
package help the consumer to control the amount of fat in their meals,
and to follow an "appealing, reduced-calorie, low-fat diet," says the
company.
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FDA Statement on Orlistat |
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FDA Approval of Orlistat for Over-the-Counter Use
Feb. 7, 2007 - The Food and Drug Administration (FDA) today
approved orlistat capsules as an over-the-counter (OTC) weight loss aid
for overweight adults. Orlistat was initially approved in 1999 as a
prescription drug to treat obesity, and remains a prescription drug for
obesity at a higher dose than the OTC version. OTC orlistat will be
manufactured by GlaxoSmithKline under the name Alli and is indicated for
use in adults ages 18 years and older along with a reduced-calorie,
low-fat diet, and exercise program.
"We know that being overweight has many adverse
consequences, including an increase in the risk of heart disease and
type 2 diabetes," said Dr. Douglas Throckmorton, Deputy Director for
FDA's Center for Drug Evaluation and Research. "OTC orlistat, along
with diet and exercise, may aid overweight adults who seek to lose
excess weight to improve their health."
OTC orlistat is not for people who have problems
absorbing food or for those who are not overweight. Orlistat helps
produce weight loss by decreasing the intestinal absorption of fat. The
60 mg capsule can be taken up to three times a day with each
fat-containing meal. Because of the possible loss of certain nutrients,
it is recommended that people using orlistat should also take a
multivitamin at bedtime.
The most common side effect of the product is a
change in bowel habits, which may include loose stools. Eating a low
fat diet will reduce the likelihood of this side effect. Also, people
who have had an organ transplant should not take OTC orlistat because of
possible drug interactions. In addition, anyone taking blood thinning
medicines or being treated for diabetes or thyroid disease should
consult a physician before using orlistat.
FDA approved OTC orlistat based on the review of
the sponsor's safety data and after submitting the product for the
consideration by an FDA advisory committee in January 2006. The
committee voted in favor of OTC approval.
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The FDA approval says, "the most common side effect
of the product is a change in bowel habits, which may include loose
stools. Eating a low fat diet will reduce the likelihood of this side
effect.
"Also, people who have had an organ transplant
should not take OTC orlistat because of possible drug interactions.
"In addition, anyone taking blood thinning
medicines or being treated for diabetes or thyroid disease should
consult a physician before using orlistat (alli)."
"Consuming a meal with too much fat, while taking
alli, can result in bowel changes such as having an urgent need to use
the bathroom," acknowledges the company.
"These changes, called treatment effects, generally
occur in the first weeks of treatment, are not harmful, and can be
managed by following the recommended diet with about 15 grams of fat per
meal. Users should take a multivitamin once a day, at bedtime, because
alli can reduce the absorption of some vitamins," adds GSK.
GSK Consumer Healthcare says it selected "alli" as
the brand name because it conveys the concept of partnership with
consumers in their weight-loss efforts.
The company emphasized this is the first
clinically-proven over- the-counter product to be combined with a
comprehensive support program. The approval marks the start of an
educational program that includes a series of resources online at
myalli.com.
To help consumers get off to a successful start,
the alli package will include Welcome and Companion Guides, a Guide to
Healthy Eating, a Daily Journal, a Calorie and Fat Counter, Quick Fact
Cards, and free access to an individualized online action plan at
myalli.com.
Caroline Apovian, M.D., Director of the Center for
Nutrition and Weight Management at Boston Medical Center welcomed the
FDA decision. "I applaud the alli program for stressing the importance
of a reduced-calorie, low-fat diet in conjunction with a weight-loss
medicine proven to be safe and effective.
"This lines up with research that shows even
modest, gradual weight loss provides significant health benefits."
Apovian adds, "More and more people each year -- now two-thirds of all
American adults -- are overweight or obese and still gaining weight.
"Desperate to lose this excess weight, people
resort to all types of extreme methods that promise everything and
deliver no real results. Extremely restrictive diets are unrealistic to
maintain, even for a couple of weeks. Dieters end up gaining more weight
than they initially lost. It's time consumers readjust their thinking to
realize positive results."
"With alli, we're excited to offer a revolutionary
approach to weight loss," says Steven L. Burton, Vice President, Weight
Control, GlaxoSmithKline Consumer Healthcare. "alli is more than a pill
-- it's a comprehensive program that works in conjunction with a
sensible diet to increase weight loss.
"Because weight loss doesn't happen overnight,
we're starting to educate consumers now about the importance of
realistic expectations, gradual weight loss and lifestyle changes.
That's the way to see results, and with alli, we know they can do it."
The company says "alli (60 mg orlistat capsules) is
safe and effective when used as directed.
"As the most extensively studied weight-loss
medication on the market, the safety and efficacy of orlistat is very
well established.
"A higher dose of orlistat has been marketed as the
prescription drug Xenical(R) (orlistat 120 mg capsules) in the U.S.
since 1999 and is supported by nine years of worldwide use in 145 other
countries. Orlistat experience in more than 25 million patient
treatments and more than 100 clinical studies with more than 30,000
patients is unprecedented.
"One of these studies with Xenical is the four-year
landmark XENDOS trial conducted by Roche, its inventor and manufacturer.
This study is the longest study ever conducted for a weight-loss
medicine.
Xenical (orlistat 120 mg capsules), will remain
available by prescription for those who should be treated under the care
of a physician. Xenical will continue to be manufactured and sold by
Roche Holding AG.
Editor's Notes:
About GlaxoSmithKline Consumer Healthcare
GSK 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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