Some dogs like to chase the Mailman, but the government representative that raises this hound dog’s hackles is the FDA! Being a major advocate of healthy and natural weight loss, hearing about the recent endorsement by the FDA of the prescription obesity drug Qnexa, was enough to warrant a closer investigation.
What gives? I thought this was a cold case; the very same FDA banned Qnexa back in 2010, and yet on February 23, 2012, in a 20-to-2 decision, the FDA announced it endorsed Qnexa. An endorsement is NOT a decision for approval, but it clears the path for one. If approved, Qnexa will become the first FDA approved prescription drug for Obesity since it rightfully pulled the last supposed “miracle pill” Xenical, from the shelves in 1999. So much for 13 years of relative sanity! A final decision on approval is due by April 17th.
As I suspected, sniffing around, it comes as no surprise that the “big news’ about Qnexa is not being reported in the main stream press as a breaking health story – but a major business story. According to Bloomberg Business Week, the stock of Vivus, Inc. the pharmaceutical company that makes Qnexa, jumped 98 percent in its first day of trading immediately following the FDA’s announcement. Analysts estimate that the drug, if approved, may generate $448 million in sales for Vivus in 2015. Forbes magazine reported that “Given past sales figures for diet drugs, Vivus can expect to make a boatload of cash on Qnexa and shareholders will smile all the way to the bank. One analyst predicted the drug could be the ‘next Lipitor,’ resulting in millions of prescriptions.”
At What Price?
There is a reason why there has not been a prescription diet pill on the market in 13 years, and why there is such a long history of those that the FDA does approve, being banned years later. Such prescription medicines can lead to weight loss, as in Vivus’s claim that users of Qnexa lost up to 10% of total body fat, but such results usually come with a heavy price in side effects. Mike Hukman, Health Reporter with CNBC has said, “Qnexa is made up of two old drugs. One is what some refer to as the good half of the infamous Fen-Phen. In other words, the half that didn’t cause the heart trouble that doomed that diet craze and cost Wyeth billions of dollars. And the other ingredient is Johnson & Johnson’s Topamax for migraines and epileptic seizures, which also has a history of side effects.”
Indeed, Qnexa is not a new drug, but a drug cocktail made up of Phentermine and Topiramate. According to the drug’s manufacturer, these ingredients suppress the user’s appetite, which enables them to drop unwanted body fat more quickly. However, there are a number of warnings that apply to Qnexa, and a lot of reasons to steer clear of it, even if the FDA reverses its opinion from 2010, and approves the drug next month. Phentermine is basically “speed” as said by Dr. Marc Seigel, Medical Codependent for Fox news. As Mike Hukman accurately reported, Phentermine is the other half of the deadly diet pill Fen-Phen.
Amphetamines and drugs like Phentermine suppress appetite by triggering the release of catecholamines. These hormones do suppress appetite, but they also are known to have two heart-related side effects: tachycardia (increased heart rate) and elevated blood pressure. These side effects don’t happen with the frequency and severity that they do with true amphetamines, but patient complaint boards are full of people posting messages about worrisome spikes in heart rate and blood pressure and resulting heart palpitations. Nurse Practitioner, Patricia Nevins speaking to Forbes magazine described it this way, “Phentermine hydrochloride affects the cardiovascular system in much the same way that fear, excitement and anger do. Essentially an amphetamine, phentermine stimulates the part of the central nervous system that regulates the heart and blood pressure. The cardiovascular effects of phentermine can cause serious heart problems.”
The National Institutes of Health (NIH) has reported those with even moderately elevated blood pressure, should avoid taking Phentermine. Since hypertension usually accompanies most people who are over weight – this should be a red flag. The NIH also warns that the appetite suppressant quality of Phentermine, peaks after a few weeks usage, and warns against increasing the dose to continue the effect. But it smells to this hound like that is something that Qnexa’s makers are banking on!
According to Drugs.com Common side effects listed for Topamax (the other half of the cocktail) include:
Constipation; decreased sweating; diarrhea; dizziness; drowsiness; dry mouth; flu-like symptoms; headache; loss of appetite; nausea; nervousness; numbness or tingling of the skin; runny nose; sore throat; stomach pain or upset; taste changes; tiredness; trouble and trouble sleeping.
Possible Qnexa severe side-effects listed are:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; blurred vision; bone pain; chest pain; confusion; decreased coordination; double vision or other vision changes; eye pain or redness; irregular heartbeat; loss of consciousness; memory problems; menstrual changes; muscle or joint pain, cramps, or weakness; new or worsening mental or mood changes (eg, aggressiveness, agitation, anxiety, depression, exaggerated feeling of well being, hostility, impulsiveness, inability to sit still, irritability, panic attacks, restlessness; rapid, shallow breathing; red, swollen, blistered, or peeling skin; ringing in the ears; severe or persistent loss of appetite; severe stomach, side, or back pain; significant weight loss; speech problems; stupor; suicidal thoughts or actions; tremor; trouble thinking,concentrating, or remembering things; trouble walking; unexplained fever; unusual bruising or bleeding; unusual eye movements; unusual tiredness; vomiting.
Interesting how “severe weight-loss or loss of appetite” was originally reported as a side effect of prescribing Topamax for migraine. Leave it to a Pharmaceutical company like the geniuses at Vivus to find a way to capitalize on a side effect!
A quick online search of the potential side effects associated with the combination of drugs in Qnexa reveals this diet drug can lead to stroke, memory loss, increased risk of suicide, and even heart attacks.
As to what the long term side-effects are or can be with the two drugs taken together as they are in Qnexa, that remains to be seen, and won’t really all come to light until after the FDA approves the drug and it is embraced by an increasingly obese population looking for the next miracle. Which is exactly what happened with Phen-Fen. I don’t know about you, but I’d rather be a Health Hound than a Guinea Pig!
The Difference Between Diet Pills and Nutritional Supplements
This Hound knows the difference between a so-called “diet pill” and natural nutritional supplements that have been proven to safely and effectively aid in weight loss. First and foremost prescription diet pills are filled with powerful and harmful drugs, usually “speed” or some derivation thereof such as the Phentermine in Qnexa. Nutritional Supplements on the other hand have only natural ingredients with very few if any dangerous side effects, which either boost metabolism, or curb hunger, leading to weight loss. Unlike most Nutritional Supplements used for weight-loss, Prescription Diet Pills such as Qnexa:
- Do not boost metabolism and increase thermo genesis.
- Do not heighten energy levels, or improve stamina.
- Do not include a healthy diet plan or fitness regimen included with the prescription medication.
Pass on the Pills
There will always be a segment of the population that is so morbidly obese, for whom medical intervention such as surgery, or even an approved and relatively safe prescription drug is the only answer. If that pill turns out to be Qnexa, remains to be seen, but if history is any indication, I doubt it very much.
The fact of the matter is for the rest of us there isn’t, and probably never will be a “magic pill” that can safely and effectively do for you, what eating sensibly and chasing cars, cats, or whatever it is you do for exercise, can do for you to lose weight and keep it off. So this dog says, pass on the pills, start a sensible diet plan, and get up and get moving!
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