Qnexa, new weight loss drug, could be first approved by FDA in 13 years
It has been more than a decade since the FDA approved a new prescription diet pill, but a new weight-loss medication is very close to being introduced to the market.
Qnexa, which is made by Vivus Inc., cleared a major hurdle toward FDA approval Wednesday when an independent group of medical experts recommended that the drug be brought to the market.
The group found that the significant weight loss benefits of the new drug outweighed its potential risks.
Frazier Harzell, 20, knows first hand about benefits that he reaped from using Qnexa.
"I went from 390 pounds to 225 pounds," Harzell said. "It definitely changed my life."
The pill, which studies have shown can produce an average of about a 10 percent loss in body weight over the first two years of use, could be a silver bullet to the almost one-third of adults and 17 percent of American children who are obese.
"Qnexa would be the most potent medicine we would have on the market to treat obesity," Dr. Tim Garvey from the University of Alabama at Birmingham said. "The currently available drugs are not very effective."
It still has its opponents though, based on the threat of side effects and the idea that diet drugs simply sometimes don't work as advertised.
Some officials are still concerned about potential side effects, including an increased heart rate, kidney stones, memory loss and birth defects.
"I think diet drugs really fall squarely in the category of 'it's too good to be true,'" Dr. Sidney Wolfe said.
However, if approved, Qnexa could be the answer for 65 million people who need help losing major weight.
"We go from Weight Watchers to bariatric surgery, and that leaves probably 65 million people who need a new option to address obesity," Joe Nadglowski, the head of the Obesity Action Coalition, said.