There ARE healthier ways to lose sickness and find wellness...Our mantra "Eat well, exercise, and supplement intelligently" is how we live and what we teach. Would you like a health coach? Contact Beth at bb@orlampa.com or 727.492.8212. Beth is a CERTIFIED lifestyle coach and can create a plan that makes sense for you without the adverse health risks.
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Drug Trades Brain Damage for Minimal Weight Loss
How much risk is acceptable in the attempt to lose
weight? The FDA seems to believe that there’s virtually no limit, not
even a very large risk of brain damage, among many other adverse
effects, from the new drug Qsymia.
Article by Heidi Stevenson courtesy of GalaHealth.com
The latest entry into the prescription weight-loss drug market, Qsymia
®,
is a combination of two dangerous drugs, one of which, topiramate
(Topamax brand name), is known to cause brain damage. Perhaps it’s worth
that risk in the population for which it was originally designed:
epileptics. However, taking topiramate as a diet aid means taking the
gamble that a little weight loss won’t also result in nerve damage,
vision damage, nervousness, speech damage, inability to concentrate,
loss of control over body movements, or any of many other indications of
brain damage.
The FDA approved Qsymia with only nods to other risks, including
contraindication in people with hyperthyroidism or glaucoma, or pregnant
women because of an increased risk of birth defects. They made no
mention of the known risks of topiramate and the other drug phentermine.
Studies show that Qsymia provides an average of 3.5 – 9.4 kilograms
(7.7 – 20.7 pounds) extra weight loss over placebo. Marvin Lipman, MD,
of Consumer Reports, refers to the requirement that the manufacturer,
Vivus, produce an after-approval trial:
The very idea that a post marketing risk evaluation
strategy was a condition required by the FDA for approval of this
combination drug product seems like putting the cart ahead of the horse.
Such a study may very well result in preventable mortality and
morbidity, a high price to pay in exchange for a few pounds of flesh.
People who are placed on Qsymia are expected to take it every day for
the rest of their lives. Experience of trial subjects has shown that
any weight lost as a result of the drug will be regained. Therefore,
risks of the drug are not temporary. Let’s take a look at the risk
profiles of each of the Qsymia drugs:
| Phentermine |
Topiramate |
Frequency Not Defined
- Hypertension
- Palpitations
- Tachycardia
- Blurred vision
- Chills
- Dysphoric mood
- Dysuria
- Excitement
- Headache
- Insomnia
- Nervousness
- Restlessness
- Tremor
- Urticaria
- Hair loss
- Impotence
- Bad taste in mouth
- Constipation
- Diarrhea
- Drug-induced gastrointestinal
disturbance
- Dry mouth
- Nausea
- Vomiting
- Myalgia
Serious
- Heart valve disorder
- Psychotic disorder
- Primary pulmonary hypertension
|
>10%
- Dizziness (26-30%)
- Fatigue (26-30%)
- Ataxia (16-20%)
- Nervousness (16-20%)
- Paresthesia (16-20%)
- Psychomotor slowing (16-20%)
- Abnormal vision (11-15%)
- Anorexia (11-15%)
- Confusion (11-15%)
- Decreased concentration (11-15%)
- Decreased memory (11-15%)
- Depression (11-15%)
- Nausea (11-15%)
- Nystagmus (11-15%)
- Speech disorder (11-15%)
- Weight loss (11-15%)
1-10%
- Abdominal pain (6-10%)
- Diplopia (6-10%)
- Mood problems (6-10%)
- Pharyngitis (6-10%)
- Tremor (6-10%)
- Abnormal gait (1-5%)
- Apathy (1-5%)
- Asthenia (1-5%)
- Dry mouth (1-5%)
- Kidney stones (1.5%)
- Menorrhagia (1-5%)
- Skin disorder (1-5%)
- Taste change (1-5%)
|
| Note: These adverse
effects of phentermine and topiramate come from Medscape. They have
changed their method of reporting adverse effects. When they compiled
them for phentermine, they were divided into more or less serious
groups. Now though, Medscape reports on the percent of patients known to
suffer from each of the adverse effects. | |
Careful scanning of these two lists shows that both have effects on
the brain and central nervous system. Both can cause depression, called
“dysphoric mood” in phentermine adverse effect and “depression” or “mood
problems” in topiramate. In fact, although topiramate is noted for its
adverse neurological effects, the fact that phentermine has been noted
as capable of inducing psychosis should cause people who might take
Qsymia to think twice.
When drugs are combined, their risks are often increased and new ones
can show up. Since we know that both phentermine and topiramate can
induce serious neurological effects, what will prove true of Qsymia?
The manufacturer, Vivus, admits that the drug combination can cause mental problems. On their own
website, they state:
Qsymia may affect how you think and is associated with
difficulty with attention and concentration, memory and word-finding.
Therefore, use caution when operating hazardous machinery, including
automobiles.
On that page, they also warn patients about risks to their vision,
the potential of a racing heartbeat, and that it can cause low blood
sugar—though they suggest only that diabetics may have their diabetes
drugs modified by their doctors.
Phentermine is also associated with a deadly heart valve disorder.
That’s the reason another diet drug combination was withdrawn. One of
the drugs in that combination was phentermine.
Even the FDA admits that the safety of Qsymia is not clear in
relation to heart disease. So, a condition of approval is that the
manufacturer must do a post-marketing study on its safety in regard to
its effect on the heart. If you think that your interests and safety are
the FDA’s central concerns, surely this fact will open your eyes!
Topiramate can make you stupid. I’ve personally witnessed that effect
on a loved one. His normally active and sharp mind deteriorated
dramatically, to the point where he could barely converse. His
concentration was destroyed. Later, he told me how utterly frustrated he
was at being unable to focus on anything. Fortunately, those symptoms
were temporary for him. They are not, though, unusual. Would you want to
take the chance that your normal intelligence and concentration might
never return?
We know that virtually no drug’s negative profile is known at the
time of approval. In the case of this one, we have the advantage of
knowing in advance a significant portion of the problems that can be
expected. However, the combination of drugs is almost certain to produce
even more harm.
While it’s certainly true that severe obesity is, itself, a serious
risk to health, just how much extra risk is worth taking in exchange for
a few pounds—especially when that risk will be induced for the rest of a
person’s life?
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There is a BETTER way...
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If you are looking for a CERTIFIED lifestyle coach to help you with your wellness objectives, please contact Beth at bb@orlampa.com or 727.492.8212.
If you are a
healthcare provider who would like to add nutritionally based wellness programs
to your practice, please contact Beth at bb@orlampa.com or 727.492.8212.
Orlampa Enterprises, Inc. specializes in helping health care professionals
implement holistic wellness programs into their existing practice with the goal
to educate both the health care provider and the patient. The programs, which
provide the health care professional with a substantial additional income
stream in this ever changing medical marketplace, allow the patient to achieve
true wellness instead of receiving a traditional treatment for symptoms.
Orlampa Enterprises is an internet based product broker specializing in
personalized health and wellness related services. Orlampa Enterprises is
primed to continue its growth by duplicating its successful business model of
educating, training, and developing entrepreneurial leaders as business partners.
As an Unfranchise™ business owner, Orlampa Enterprises, proudly utilizes highly
researched products including nutraMetrix® nutritional supplements.
Orlampa Enterprises' motto is "Eat well, exercise, and
supplement intelligently."
Contact bb@orlampa.com for more information about nutraMetrix® partnership
opportunities available.