Earlier this year, Dr. Oz introduced Dr. Craig Primack of the Scottsdale Weight Loss Center who admitted to off-label prescribing a controversial weight loss drug combo that thus far has shown promise in aiding significant weight loss. This week, researchers will present at a major scientific meeting their latest results of a study testing this off-label prescribed weight loss drug combo on obese patients with Type 2 diabetes.
Off-label prescription is an increasingly common practice of prescribing mediations in a different dose, a longer duration of time, or for a different medical indication than specifically approved by the FDA. Some people view this as a type of medico/ legal loophole where a physician has the personal discretion to prescribe a variety of medications in combination with other medications in the treatment of patients. In this case, the off-label prescription weight loss pill promoted on the Dr. Oz Show was actually a combination of two separate medications known as phentermine and topiramate, that in their combined single pill form goes by the name Qnexa—which is expected to meet FDA approval this July.
The controversy of this weight loss combo is that one of the medicines—phentermine—was once part of the infamous fen-phen diet pill combination that was withdrawn in 1997 after it was determined to be causing damage to heart valves. Today, the stimulant phentermine is legally approved for short-term use for weight loss management. The other medication—topiramate—is also a legally prescribed drug used for treating epilepsy and migraine headaches.
For the past few years, accumulating evidence has demonstrated that phentermine’s weight loss properties are enhanced in conjunction with topiramate resulting in a significant amount of weight loss in obese individuals in a relatively short time without the pain of hunger or feeling food deprived during dieting. In fact, the latest study results that are being presented at the Endocrine Society's 94th Annual Meeting in Houston reveal that the phentermine/topiramate experimental drug combo significantly aided overweight patients with Type 2 diabetes shed pounds, in comparison to a control population of Type 2 diabetics given a placebo.
"This new medication is promising because of the amount of weight loss it produces, the resultant improvement in important risk factors for diabetes, and, particularly in the lower dose studied, in its tolerability," said study lead author Donna H. Ryan, M.D., professor emeritus at Pennington Biomedical Research Center (LSU System) in Baton Rouge, LA.
In a double-blinded study, 357 patients with type 2 diabetes were treated with either low-dose phentermine/topiramate (7.5 milligrams), high-dose phentermine/topiramate (15 milligrams), or a placebo. The patients’ average age and weight was 53 years and 222 pounds respectively, with 66 percent of the participants being female. The patients were part of a weight loss study that analyzed the effect of combining a weight loss pill with diet and exercise.
The results of the study demonstrated that the percentage of study participants losing more than 10 percent of their initial weight broken down by dose is:
• 14 percent on low-dose phentermine/topiramate
• 31 percent on high-dose phentermine/topiramate
• 4 percent on placebo
The conclusion reached by the researchers is that when focusing on type 2 diabetes, patients who took the experimental weight-loss drug phentermine/topiramate in combination with diet and exercise were more likely to lose moderate amounts of weight than those who received a sugar-pill placebo along with a diet and exercise program. Side effects reported in the study include constipation and tingling sensations in the fingers.
Two years ago the FDA refused to approve Qnexa because there was evidence that taking Qnexa increased the risk of developing cardiovascular problems and causing birth defects among other medical issues. Currently, however, with additional studies submitted, the phentermaine/topiramate combination drug marketed as Qnexa has passed muster with an FDA advisory panel and is now in the hands of US Food and Drug Administration officials who are scheduled to announce on July 17th whether or not to grant the weight loss drug full approval. If approved, Qnexa will be the first diet drug approved in more than a decade in the U.S.
Follow this link for a related article titled "Did Dr. Oz Guest Off-Label Prescribe Weight Loss Silver Bullet?"
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