By MELINDA BECK
July
30, 2012, 6:50 p.m. ET
Piper
Miguelgorry started gaining weight in her 30s and 40s, after having three sons.
The environmental researcher from Folsom, Calif., tried many diet regimes,
without success, until she found a weight-loss center in nearby Roseville,
where phentermine, a prescription appetite suppressant, was part of the plan,
along with a high-protein, low-carb diet.
"Much to my surprise, I lost 50
pounds," says Mrs. Miguelgorry, 58, who has kept it off for more than a
year. She also beat Type 2 diabetes and cut her cholesterol in half. She
credits phentermine with helping reduce her craving for carbohydrates and plans
to stay on it indefinitely.
Two
diet pills just approved by the FDA, Qsymia and Belviq, won't be available for
several months, but some doctors have been prescribing the ingredients of
Qsymia (a migraine drug and phentermine, an old diet pill) to patients for
years specifically for weight loss. Melinda Beck on Lunch Break explores the
risks and side effects. Photo: AP.
Physicians
who treat obesity hailed the Food and Drug Administration's recent approval of
two new diet drugs—the first in 13 years—as a new era in weight-loss
management. But some obesity specialists, including those at prestigious
medical centers, have been prescribing medications to help patients lose weight
for decades, both on and off-label.
Those
medications include phentermine and several other stimulants approved for
weight loss in the 1950s, as well as drugs to treat diabetes, depression and
attention-deficit disorder that have weight-loss as a side effect.
One
of the newly approved drugs, Qsymia, is a combination of phentermine and
topirimax, a drug for easing seizures and migraines that also tends to make
people feel full. The other, Belviq, works on brain receptors for serotonin, a
neurotransmitter than triggers feelings of satisfaction.
Physicians
can legally prescribe medications for uses not specifically approved by the
FDA. But most obesity doctors do so cautiously given the history of diet pills
removed from the market due to serious side effects including death.
"The
fact that we've got two new drugs approved will reaffirm to the public that
this truly is a medical problem and there's a place for pharmacotherapy,"
says Ed Hendricks, head of the Center for Weight Loss Management, which treated
Mrs. Miguelgorry.
While
some experts argue that people who are obese should simply eat less and
exercise more, many physicians who treat obesity say it is driven by biological
changes in the body, not lack of willpower.
"People
say, 'Why are you treating a lifestyle problem with medication?' If you think
that, you don't understand obesity," says Louis Aronne, director of the
Comprehensive Weight Control Program at New York Presbyterian Hospital/Weill
Cornell Medical College. He says there is mounting evidence that in some people,
neurons in the hypothalamus that should recognize when the body has stored
sufficient fat and either cut food intake or boost energy expenditure aren't
working properly. Medications can help, says Dr. Aronne, who oversaw clinical
trials of Qsymia.
In
trials of 3,700 obese and overweight patients, those who took Qsymia for one
year lost 6% to 9% more of their body weight than those on a placebo. Nearly
70% lost at least 5% of their weight.
With
Belviq, of nearly 8,000 patients studied, those on the drug lost about 4% more
than those on placebo. All were also counseled to exercise and eat a reduced
calorie diet. The FDA says people who don't lose at least 5% of their weight in
12 weeks should discontinue the drugs.
People
who eat very large portions or think about food all the time, even right after
a meal, aren't getting biochemical signals to stop eating and may find drugs
helpful, says Robert F. Kushner, clinical director of the Comprehensive Center
on Obesity at Northwestern University.
People
who eat for emotional reasons tend to benefit less, although drugs can help
clarify their motivations. "If you give a medication that makes them feel
full, but they still keep eating, it becomes very clear that it really is
emotional," says Dr. Kushner, chairman of the American Board of Obesity
Medicine.
The
new drugs are FDA approved for patients with a body mass index of 30 or higher,
or with a BMI of 27 and high blood pressure, diabetes, high cholesterol or
sleep apnea. People with very large amounts of weight to lose may benefit more
from bariatric surgery, or a combination, doctors say. The drugs aren't covered
by most insurance companies. They are expected to be available this fall.
Most
of the drugs currently prescribed for weight loss suppress appetite by
affecting neurotransmitters, which send signals in the brain. Stimulant
medications are among the most powerful. The FDA approved several
stimulants—including phendimetrazine (marketed as Bontril) and diethylpropion
(Tenuate)—specifically for weight loss in 1959. They remain on the market
today.
How They Work
Drugs
sometimes prescribed for weight loss work in various ways.
·
Stimulants rev up the central nervous
system.
·
Antidepressant drugs such as
buproprion (Wellbutrin) affect brain chemistry.
·
The diabetes drug metformin
(Glucophage) reduces the impact of blood sugar. Liraglutide (Victoza) boosts a
gut hormone to promote fullness.
·
The FDA-approved obesity drug orlistat
(Xenical, Alli) blocks fat absorption.
·
Naltrexone (Depade, ReVia) blocks
opiod receptors and makes food less appealing.
The
best known is phentermine, half of the popular fen-phen combination in the
1990s until fenfluramine was linked to heart-value damage and discontinued in
1997. Because they are potentially addictive, phentermine and the others are
approved for short-term use only. "But all of us use it long-term,"
says Dr. Kushner. Dr. Hendricks, who says he has treated 15,000 patients with
phentermine, alone and in combinations, over 23 years, and says that patients
who keep taking it tend to maintain their weight loss. Drs. Aronne, Hendricks
and Kushner all consult for drug makers.
ADHD
drugs including Ritalin and Adderall also suppress appetite in some patients,
but most obesity doctors use older generic stimulants. Patients with heart
disease, high blood pressure, hyperthyroidism or glaucoma should not use
stimulants.
The
diabetes drug Metformin helps decrease the amount of sugar the body absorbs
from food and increases the body's response to insulin. Some patients can
experience dangerously low blood sugar.
It
is unclear why bupropion (Wellbutrin) doesn't make patients gain weight the way
other antidepressants do, but it may help ease cravings. (Last month,
GlaxoSmithKlein agreed to pay a $3 billion fine in part for promoting
Wellbutrin for weight-loss and other off-label uses.)
Naltrexone
(Depade, ReVia) helps alcoholics stop drinking by blocking opiod receptors in
the brain, diminishing the kick booze provides. It may make food less rewarding
the same way. Side effects, in rare cases, may include liver damage.
Some
clinics promote human chorionic gonadotropin (hCG), an infertility treatment,
as a way to "reset metabolism" when combined with a 500-calorie-a-day
diet. But obesity experts say there is no evidence that hCG works better than a
placebo. The FDA has warned seven companies to stop selling over-the-counter
hCG and making unsupported claims.
Respected
obesity experts say consumers should be wary of purported diet drugs sold over
the Internet, as well as doctors who sell drugs from their offices, with little
or no evaluation or without a comprehensive weight-loss plan.
Diet Drugs Over the Years
Medications
the FDA approved, rejected or the makers withdrew
Years
on the U.S. Market
|
Drug
(Brand Name)
|
Comment
|
1949-1979
|
Amphetamine
|
Discontinued
due to potential for abuse
|
1959-present
|
Phentermine and other anoretics
|
Appetite suppressants; approved
for short-term use only
|
1960s
|
'Rainbow
pills'
|
Amphetamine,
digitalis, diuretics combined; discontinued after links to several deaths
|
1973-1997
|
Fenfluramine (Pondimin)
|
Often combined with phentermine
in 'fen-phen'; withdrawn after links to heart value problems
|
1996-1997
|
Dexfenfluramine
(Redux)
|
Similar to
fenfluramine; withdrawn after links to heart value problems
|
1997-2010
|
Sibutramine (Merida)
|
Withdrawn due to risk of heart
attack, stroke
|
1999-present
|
Orlistat
(Xenical, Alli)
|
Blocks fat
absorption
|
2007 (rejected)
|
Rimonabant (Acomplia)
|
Suspected link to suicidal
thoughts
|
2011
(rejected)
|
Contrave
|
Combines an
antidepressant and an alcoholism drug; now undergoing more trials
|
2012
|
Qsymia, Belviq
|
Approved after additional data
submitted
|
A
version of this article appeared July 31, 2012, on page D1 in the U.S. edition
of The Wall Street Journal, with the headline: New Diet Pills Offer Option To
Off-Label Obesity Drugs.
Copyright
2012 Dow Jones & Company, Inc. All Rights Reserved
