Qnexa, a diet pill created by Vivus, Inc., that claims to help dieters lose 10% of their weight when combined with diet and exercise, has been approved by the FDA advisory panel in a landslide vote of 20-2.
The panel had previously rejected the the pill due to safety concerns, which has left its opponents concerned. Since the FDA typically follows the advice of its advisory panel, the drug is likely to be approved by mid-April.
Previous concerns about the drug are still present. And if the pill does go on shelves, potential users should be aware of that. One of Qnexa’s main ingredients is phentermine, a type of amphetamine that stimulates the nervous system and increases heart rate and blood pressure. It’s commonly used in diet pills since it suppresses appetite, and was woefully recognized as the “Phen” in the weight loss drug Fen-Phen, which was yanked from the market by the FDA in 1997 after being deemed too dangerous for consumption.
Phentermine is not only suppresses appetite and highly addictive, but it’s also been know to have such side effets as nausea, vomiting, dry mouth, heart disease, diarrhea and constipation.
However, supporters of Qnexa say that it produces dramatic weight loss and helps reduce diabetes and lowers blood pressure and other cardiovascular risk factors. When asked why the drug was approved after being first rejected, FDA advisory panel chairman Abraham Thomas said it was because more data was present to better understand the benefits of Qnexa compared to the health risks in the greatest areas of concern, being the risk of birth defects and the effects it has on cardiovascular disease.
Though several research patients were shown to have increased heart rate after taking the pill, the advisory panel argued that although heart rate went up slightly, it was minimal; and that blood pressure went down. Panel members eventually concluded that the health benefits for patients losing 5-10% of their weight was reason enough to approve the drug, since they claim many people can’t lose that weight through diet and exercise alone.
If it’s any comfort to the drug’s opponents, the panel is reportedly working with Vivus to ensure appropriate labeling gets put on the bottle to warn pregnant women and women planning to become pregnant from taking the pill, as it’s been deemed a potential danger to their health.
April 5th, 2012