Rejection for Weight Loss Drug Qnexa by FDA
A third high profile weight loss drug has just been rejected by the FDA. Qnexa now follows in the footsteps of two other diet drugs to fall by the wayside, Lorcaserin and Meridia.
Health Concerns and Safety Risks
Qnexa is the third diet drug that has been thrown out by the FDA this month over concerns about certain health aspects and safety risks. The drug's developer, Vivus, said in a statement published on its website in Thursday that the FDA made a request of the company to provide a thorough evaluation of the potential for the drug being a cause of heart problems and birth defects.
The company is confident they will be able to provide the necessary reassurances within six weeks. If those results satisfy the board, there is a good chance the rapid weight loss drug may be approved early next year.
The last time a weight loss drug gained approval by the FDA was as long ago as 1999, when Roche's Xenical became available for public use. In fact Xenical is the only drug that is approved for use in the long term.
The results produced by Qnexa were quite impressive as far as diet drugs are concerned, managing to produce almost twice the level of weight loss as many other diet drugs. During clinical trials of the drug, patients taking the highest dose lost 10.6 percent of their body weight after one year on average, This compared with just 1.7 percent for the control group taking a placebo.
Two Drug Combination
Qnexa is based on a combination of two drugs. These are phentermine, which is a stimulant already approved for losing weight in the short-term and topiramate, which is an epilepsy and migraine drug. Topiramate is sold under the name Topamax by Johnson & Johnson.
The decision by the FDA to reject Qnexa was not entirely unexpected. This is because an advisory committee had already voted 10 to 6 against approving the drug back in July.
This news story is a concise, paraphrased version of the full story, which you can read here in the New York Times.
The Dangers of Drugs
Whatever you may think about the possibility of the creation of a perfectly working, effective and affordable drug for weight loss, there must always be that nagging doubt in the back of your mind as to how safe it really is. To date, the vast majority of pharmaceutical drugs come with certain side-effects.
It is the side-effects of drugs that make them far less attractive than they ought to be. This is because in some cases those side-effects can be as hard on health as the condition they're being taken to deal with.
This leads me back to my own ideas about losing weight where I oppose the use of any kind of ″quick fix″ treatments or magic pills and prefer the natural approach to the problem. That is to target the main underlying cause of weight gain, which is faulty diet coupled with a sedentary lifestyle.
There really is no substitute for eating a healthy, wholesome diet of natural foods untarnished by the so-called food industry and the processing and additives that make up their products. For products is exactly what they are; that stuff is not real food!
The human body is designed to best digest and metabolize whole food in its natural state. When unnatural ingredients are introduced into that food, the body has a hard time dealing with them.
Health and well being are impacted by toxic additives. When that food contains excessive sugars, the body works harder to take the excess glucose out of the blood and store it in fat cells, causing the body to gain weight and get out of shape.
The explanation is very simple in essence. To avoid becoming overweight, simply avoid eating excess sugar!
That sugar is in obvious products like candy, cakes and cookies and anything else that is sweet to the taste. It is also hiding in products made from refined carbs (mostly refined white flour), such as bread, cakes, pastries and also hidden in processed, packaged food products.
By avoiding all foods that come in packages (and cans and jars) that are found on the supermarket shelves, you can make a huge difference to your health and size. Instead only eat natural foods from the fresh fruit and vegetable stalls, grass fed meat and dairy if you elect to eat a carnivorous diet and learn to prepare and cook it yourself in your own kitchen like generations past used to do.
Get your diet right first, then look to exercising to increase your fitness and tone up those flabby muscles to get in good shape.
That's the big secret that nobody is really keeping from you aside from yourself!
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Posted on Fri, 29 Oct 2010 in News | 0 Comments