By Amanda Gardner
HealthDay Reporter
(HealthDay News) -- The U.S. Food and Drug Administration's
approval of two new weight-loss drugs within the past month -- the first
such medications in 13 years -- won't be a panacea for America's
obesity epidemic, health professionals say.
And as the FDA's drug regulators reiterated
when approving the two drugs, Qysmia and Belviq, no weight-loss
medication should be used without also making lifestyle changes to
facilitate weight loss.
"The bottom line is there's no such thing as a
magic pill and I hope that individuals do not think by taking this pill
that it will ensure long-term weight loss," said Keri Gans, a
registered dietitian in New York City. "We need to be reminded that diet
and exercise are still critical."
Qysmia, formerly called Qnexa, was approved
on Tuesday and is a combination of the weight-loss drug phentermine
(brand name Adipex-P, among others) and the anti-seizure medication
Topamax (topiramate).
It is only approved for people who are obese
(a body mass index, or BMI, of 30 or above) or overweight people (BMI of
27 or higher) and who also suffer from conditions such as high blood
pressure, type 2 diabetes or high cholesterol.
Phentermine once was prescribed widely as the
"phen" part of the fen-phen weight-loss drug, which was withdrawn from
the market in 1997 after it was linked to both high blood pressure in
the lungs and heart valve disease. The problems appeared to be related
to the "fen," or fenfluramine, part of the combination, not the
phentermine.
Qsymia was initially denied FDA approval in
2010 because of potential side effects, including heart palpitations and
birth defects -- such as cleft lip in babies -- if taken by pregnant
women.
Phentermine is believed to work by controlling appetite and Topamax by speeding up metabolism.
But Topamax also has side effects, including,
possibly, numbness in the arms and legs, said Dr. Michael Aziz, an
internist at Lenox Hill Hospital, in New York City, who added that
having two drugs together could compound the side effects.
The U.S. Food and Drug Administration is
stressing that Qsymia not be used by pregnant women. Nor should it be
taken by people who have had a recent stroke or unstable heart disease
as it can speed up heart rate. Neither should it be taken by people with
glaucoma or hyperthyroidism.
And the drug can only be sold via specially certified drug stores.
"The concern is with it being
overprescribed," Gans said. "There's the concern that too many people
may have access to it when they simply need to make diet modifications
and not look for some magic solutions."
The second drug approved in the last month
was Belviq (lorcaserin), also for obese adults who have high blood
pressure, high cholesterol or type 2 diabetes.
Belviq seems to work by controlling appetite, Aziz said, but in trials it produced limited weight loss.
Belviq may cause serious side effects,
including "serotonin syndrome," particularly when taken with certain
medicines that increase serotonin levels or activate serotonin
receptors, such as drugs used to treat depression and migraine. The drug
may also cause problems with attention or memory, the FDA said.
Other common side effects of Belviq in
non-diabetic patients include headache, dizziness, fatigue, nausea, dry
mouth, and constipation. In patients with diabetes, side effects can
include low blood sugar, headache, back pain, cough and fatigue, the FDA
said.
The cost of the drug is relatively modest, at
least compared to other medications on the market, and may range
between $100 and $200 for a month's supply, Aziz said.
But neither drug, despite the splash they've
made in the news, is likely to make a significant dent in America's
obesity crisis, with two-thirds of the population either overweight or
obese.
"The problem that all the drug companies are
overlooking is the fact that obesity is really multi-factorial," Aziz
said. "It's not only related to diet and exercise but also to hormonal
imbalances, stress and lack of sleep."
