An independent panel of medical experts voted Wednesday that Qnexa’s (a new diet drug) significant weight-loss benefit outweighed its potential risks. The approval moves the decision on Qnexa to the Food and Drug Administration (FDA) for their final approval later this year. If approved, as it seems to be headed in that direction, Qnexa would be the first prescription diet drug to reach the market since 1999. It is a combination of the anticonvulsant topiramate and the appetite suppressant phentermine. Studies show the medications produced an average of about 10% loss of body weight in the first two years of use. However, last year, the FDA reclassified topiramate as a class D drug, meaning it carries risks to a fetus but may still be acceptable for use in pregnant women despite the risks. Clinical trials on Qnexa also showed an increased risk of birth defects — typically cleft lip — in women who became pregnant on the drug. The study also found that users have an increase in heart rate.
Officials have agreed that they will have a tightly controlled system for those prescribing Qnexa in order to prevent birth defects such as healthcare providing training, monthly pregnancy tests, and a patient and medication guide.
What are your thoughts or comments on this drug? Should it be approved to prevent obesity, do the benefits outweigh the risks?