FDA to give controversial diet drug second look
It's been 13 years since the Food and Drug Administration approved a prescription diet pill.
On Wednesday, it takes a second look at a drug called Qnexa, a combination of the drugs phentermine, a stimulant, and topiramate, a seizure or migraine medication.
Dr. Judith Korner, director of Columbia University's Weight Control Center, said the drug, according to the most recent year-long study, helped people lose 14.4 percent of their body weight. The statistic is based on information provided by Vivus Inc., the maker of the controversial drug.
"That's an average weight loss, and a third of the patients lost even more weight than that," Korner said. "And then there are some people who don't respond that well."
The FDA rejected the combination drug in 2010, due to safety concerns about heart problems and birth defects.
So what's different now?
The issues concerning the risks, particularly on dying of a heart attack haven't "necessarily" been addressed, Korner said.
When pressed by Charlie Rose about why those issues haven't been resolved -- particularly if they were cited in the first round of review -- Korner said reason must also be used in reviewing this drug. "The risk of obesity is already known," she said. "Obesity definitely causes heart disease and stroke."
Rose asked, "So are you saying the risk of obesity overrides any other risk from using this drug?"
"Yes," Korner said. "From the information we have now, one has to realize this is not necessarily a new drug in the way that phentermine, which probably carries the potential of more of a risk, has been around for decades and that's still out there. So if this were a true risk, then we would know. We would know that."
When asked if the FDA will approve Qnexa, Korner said, "I certainly hope that they approve it. And you can still study the drug once it's out on the market you have to realize, this is a prescription drug. People can't go to their local drugstore and next to the shampoo buy the medication, OK? They will be monitored."
For more with Korner on Qnexa, watch the video in the player above.
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