07-17-2011, 09:16 PM
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Super Moderator / Even Keel
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Join Date: Feb 2010
Thanked 1,184 Times in 928 Posts
The drug companies are sure trying to get Topamax approved for weight loss. The side effects are so serious and rather horrible, though, who would take it unless they had to in order to save their lives? The reason would have to be compelling, like for seizures, IIH, or life-altering migraines.
Anyway, the drug companies ARE trying, and they are funding studies.
Two existing drugs, in combination, have shown significant promise in promoting weight loss, according to a new report. |
The drugs, phentermine and Topamax, in combination with lifestyle and weight-loss counseling were associated with a 18-22 pound weight loss in trial participants, compared with a three-pound weight loss in patients who received counseling alone.
The drug also appears to have reduced other obesity-related indicators, such as blood pressure, cholesterol and inflammation levels.
By comparison, the only approved long-term prescription weight loss medication available on the market today, Xenical, is associated with a seven-pound weight loss when combined with diet and exercise.
The study was funded by the pharmaceutical company Vivus, which combined the two drugs into one pill called Qnexa, and petitioned the U.S. Food and Drug Administration for approval in October 2010. The Food and Drug Administration denied the request, asking for more safety data from the company before moving forward.
According to the report, there were specific concerns about each drug's safety individually; specifically Topamax, which is reported to cause some psychiatric and cognitive side effects and may cause clef palate birth defects if taken while pregnant.
An investigational weight loss pill called Qnexa combines the medications Topamax and Phentermine. Phentermine is one of the most widely-used medications for weight loss in the United States. An investigational trial has shown an average weight loss of 22 pounds in one year for patients taking Qnexa and lower blood pressure, cholesterol and blood glucose levels. Compared to patients assigned to diet and exercise counseling alone, patients taking Qnexa experienced significantly greater weight loss. However, we already know Topamax alone carries with it some serious side effects. |
Topamax has been associated with extreme nausea (likely the reason so many people lose weight on it), heart problems, cloudy thinking, lethargy and an increased risk of birth defects in babies born to women taking it. Infants born to women taking Topamax have been found to have an increased risk of cleft lip or palate. In fact, the Food and Drug Administration (FDA) recently rejected Qnexa’s application for approval as a weight loss medication because of these risks, particularly the heart risks and birth defects. While weight loss is undoubtedly a serious medical issue, the FDA did not believe the benefits of Qnexa outweighed the significant risks for the target population. However, researchers said there were no birth defects among the 34 babies born to women taking Qnexa in this trial and that based on these results they plan to reapply for FDA approval before the end of 2011.