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July 18th, 2012 
FAKE NEWS for the Zionist agenda TUESDAY, July 17 (HealthDay News) — For the second time in less
than a month, U.S. drug regulators on Tuesday approved a new weight-loss
medication.
Qsymia — formerly dubbed Qnexa — is a combination of the drugs
phentermine and topiramate, and is manufactured by the pharmaceutical firm
Vivus Inc.
“Obesity threatens the overall well being of patients and is a major
public health concern,” Dr. Janet Woodcock, director of the FDA‘s Center
for Drug Evaluation and Research, said in an agency news release issued
late Tuesday. “Qsymia, used responsibly in combination with a healthy
lifestyle that includes a reduced-calorie diet and exercise, provides
another treatment option for chronic weight management in Americans who
are obese or are overweight and have at least one weight-related comorbid
condition.”
The drug is approved only for the obese (people with a body-mass index,
or BMI, of 30 or above) or overweight people (body mass 27 or higher) who
also suffer from conditions such as hypertension, type 2 diabetes or high
cholesterol. It will be available in a standard dose but also a higher
dose “for select patients,” the FDA said.
Last year, a study funded by Vivus found that obese patients taking
Qsymia lost an average of 22 pounds over a year, while also lowering their
blood pressure and cholesterol levels.
On June 27, the FDA gave its OK to another weight-loss drug, Belviq
(lorcaserin), which was approved for obese adults who have high blood
pressure, high cholesterol or type 2 diabetes, and is to be used in
combination with a low-calorie diet and exercise.
The back-to-back approvals followed a 13-year stretch in which the FDA
did not approve any new medications to help people struggling with
overweight or obesity to lose unwanted and unneeded pounds.
In May, a study presented at the European Congress on Obesity in Lyon,
France, found that volunteers who took Qsymia experienced substantial
weight loss, even if they had many weight-related health problems. The
56-week clinical trial included 994 patients who took a placebo, 498 who
took a medium dose of Qsymia, and 995 who took a high dose of the
drug.
Back in February, an FDA advisory panel recommended that the agency
approve Qsymia for the treatment of obesity. The advisers concluded that
Vivus, based in Mountain View, Calif., had supplied enough clinical data
about the drug’s benefits and risks.
While effective at reducing weight, 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.
In fact, the FDA is stressing that “Qsymia must not be used during
pregnancy because it can cause harm to a fetus.” The drug is also not
recommended for people with either glaucoma or hyperthyroidism, and
because it can boost the heart rate it should not be taken by people who
have had a stroke or unstable heart disease within the past six months,
the FDA said.
Qsymia also comes with a special Risk Evaluation and Mitigation
Strategy (REMS), which includes an education guide for patients and
providers. The drug can only be sold and dispensed by specially certified
drug stores, the FDA added.
Before making its decision in February, the FDA advisers reviewed two
years of data on the drug; when advisers previously voted on Qsymia, only
one year’s worth of follow-up data was available.
Qsymia combines the appetite suppressant phentermine (Adipex-P) and the
anti-seizure/migraine medication topiramate (Topamax). 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 its use was linked to
both high blood pressure in the lungs and heart valve disease. The
problems were related to the “fen,” or fenfluramine, part of the
combination, not the phentermine, scientists said.
Belviq was also initially denied FDA approval. Manufactured by Arena
Pharmaceuticals of Switzerland, the drug maker first sought approval in
2010 but was turned down because animal studies showed the drug was
associated with tumor growth.
New data supplied to the FDA that allayed these fears led to the drug’s
approval last month.
Doctors and other health professionals agree that the best way to keep
off unwanted weight is through a healthy lifestyle that includes proper
nutrition and exercise. Still, the new drugs should benefit some of the
estimated two-thirds of Americans who are either overweight or obese,
experts said.
Samantha Heller, an exercise physiologist and clinical nutrition
coordinator at the Center for Cancer Care at Griffin Hospital in Derby,
Conn., told HealthDay that “obesity is often associated with
alterations in endocrine function, metabolism, hormones that regulate
appetite and more.”
For many people struggling with weight, these disruptions in the
balance of hormones and metabolism make it difficult to lose weight, she
said. People may feel hungry all the time, fatigued or lethargic. Losing
weight for people who are obese is rarely as simple as eating less, she
added.
“People need to understand that lifestyle modifications are essential
for successful weight loss, weight maintenance and fitness programs. The
weight loss reported in the studies is modest and the placebo group lost
weight too, indicating that ongoing lifestyle counseling and support have
a positive impact with and without medication,” she said.
More information
Learn more about weight-loss medications at the U.S. National Institutes of Health.
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