The FDA approved the newest prescription weight-loss drug, Qsymia. It’s been 13 quiet years since the last pound-shedding drug Orlistat came out. Qsymia's approval makes it the second weight-loss drug to hit the market in just a few weeks (Belviq was approved last month). In clinical trials, Qsymia (formerly called Qnexa), from Vivus pharmaceuticals, helped obese individuals lose about 10% of their body weight.
"Drugs like this are crucial to stemming obesity, which is such a vital issue," says Michael Roizen, M.D., YouBeauty cofounder and chief wellness officer at the Cleveland Clinic. "We have to do something if we are going to get health costs under control. If this drug helps reverse the trend even a little bit, or at the very least raises awareness of the problem, then it can be extremely valuable."
While patients on Qsymia shed twice as much weight as those who took Belviq, the outlook for the latest newcomer isn’t all rosy. The once-a-day, time-release capsule combines topiramate, an anti-convulsion medication know to cause birth defects, and phentermine, the half of fen-phen that’s still legal.
If this is sounding just a little too familiar, well, it’s not just you.
In Vivus’s first attempt to get Qsymia past regulators back in 2010, the FDA issued a letter expressing concerns over the safety of the two main ingredients. Phentermine has been on the market since 1959, but gained notoriety in the 1990s when fen-phen became all the rage – and then all the scourge. After widespread off-label use – which is to say, your aunt/best friend/boss using it to drop a dress size, as opposed to its official purpose to treat clinical obesity – it came to light that fenfluramine could cause fatal heart valve problems. The FDA pulled the bad fen off the market in the fall of 1997. Qsymia will be dispensed only through pharmacies to try to head off abuse.