Qsymia Diet Pills Are Now FDA Approved

You’ve more than likely already heard, but if not, on July 17th, 2012, Qsymia (a combination of Phentermine and Topiramate), also previously known as Qnexa was approved by the FDA.

So what does this mean for consumers?

Well basically, you now have access to this new diet drug through a prescription provided by your doctor.

Pronounced kyoo-sim-EE-uh, it is a pill that helps obese patients drop some pounds with the use of the Phentermine weight loss stimulant as well as an extended-release anti-seizure drug called Topiramate. So far we are seeing some sources advising to stay away from the pill all together as it may come with some very serious side effects. For example, the director of Consumer Report Health Ratings Center, John Santa, M.D., was quoted on the following:

These words alone are enough to make any think twice about jumping on this new lab concoction. As of right now, Qsymia is limited to a select few of pharmacies that are certified and in agreement to a mitigation and risk eval. strategy, also known as R.E.M.S.. Now, as this seems a little like they are jumping the gun, Vivus, the manufacturer has evaluated the drug by conducting two placebo controlled (randomized) trials consisting of a whopping 3,700 patients who were both diagnosed as obese and overweight. In addition, these participants didn’t have any treatments conducted on weight related conditions for up to a year. And as with most weight loss prescriptions administered, they were given a physical regimen and reduced calorie diet to follow.

Results from the two treatments over the course of one year showed that about 69% and 62% of participants walked away (at the very least) with about 5% less body weight. These results were from the recommended and highest daily doses of Qsymia (15mg Phen. and 92mg Top.) in comparison to those treated with placebos.

Long-Term Monitoring

According to the FDA Press Announcement, Vivus, Inc. of Mountain View, CA has been required to conduct cardiovascular analysis that are long-term to determine the effects of Qsymia in regards to stokes and heart attacks. The company is also required to conduct nine other postmarketing requirements.