There is a whiff of science fiction about it: two thirds of a population seems to be slowly, inexorably destroying itself. A substance comes along that stops the self-destructive behavior. However, the chemical can’t be given to women of reproductive age because of birth defects associated with it, so it will be kept under lock and key.
No, it’s not a screenplay or a scene from a dark Margaret Atwood novel. It’s the newest weight-loss medication, Qnexa. This drug got the green light from a Food and Drug Administration (FDA) advisory panel on Feb. 22, a crucial step toward approval of the drug, which is expected in April. Previously, In 2010, an FDA advisory panel nixed Qnexa, citing concerns about cardiovascular risks and birth defects associated with the drug.
With one-third of Americans obese and one-third overweight, the panel this time deemed that the benefits of Qnexa outweigh its risks. Obesity poses serious health risks, and the thinking behind the medication is that diet and lifestyle aren’t sufficient to address the problem in many people. The FDA is not required to take the advice of the panel in its final decision about the drug, but the agency generally abides by the recommendations of the advisory group.
Studies on Qnexa show that people who took the drug averaged a 10 percent loss in body weight over two years. But the results come with a price—escalated heart rate and greater likelihood of birth defects. Qnexa ups the risk of cleft lip and cleft palate significantly. It will not be prescribed to pregnant women, and women of childbearing age who take the drug will undergo monthly pregnancy tests. The drug manufacturer, Vivus, of Mountain View, Calif., pledged to put safeguards in place to monitor the drug’s use and to ensure that pregnant women do not take it.
These safeguards include training for health care providers who prescribe the drug and limited access to the drug through only a few select mail-order pharmacies. The promise of these safeguards factored into the panel’s decision to OK Qnexa this time. Vivus will also conduct additional clinical trials on Qnexa, but not until after it is approved.
Qnexa is a combination of phentermine, which suppresses appetite, and topiramate, which is used to treat epilepsy. Both phentermine and topiramate are available as individual drugs, but Qnexa combines them in extended-release form and at lower dosages.
When it becomes available, Qnexa will join
Author: Google News
Full article source: http://losalamitos.patch.com/articles/diet-pill-qnexa-the-next-big-diet-thing