We reported last week that drugmakers were seeking to get a prescription diet pill passed, and that drug is now one stop closer to your local pharmacy. On Thursday, an FDA panel of outside physicians voted 20-2 in favor of the weight-loss drug Qnexa by Vivus.
The drug had been previously rejected for safety reasons, but now seems likely that it will get full FDA approval in April, says Dr. Joe Colella
, robotic bariatric surgeon and author of Skinny People Just Don’t Get It
. Just don't expect it to be without controversy.
"The FDA advisory panel has said yes, but that 'yes' is a louder 'yes' than most because of the extremely controversial nature and checkered past of diet drugs," Colella says. "The likelihood of approval is as much an act of desperation as anything, and the pending FDA vote will elicit a barrage of opinion from both sides of the fence."
Qnexa is a combination medication made up of topiramate, an anti-seizure drug, and phentiramine, an amphetamine-like drug thought to have appetite-suppressant properties. While both drugs have already received FDA approval independently, with Qnexa, they are being used together in an attempt to solve the obesity riddle, Colella says.
People taking Qnexa for a year have seen pretty big results, including losing nearly 10 percent of their overall weight. However, the drug isn't without its risks.
"Is Qnexa safe? The truth is that we really don't know, and to a large extent, the relative safety depends on your definition of what is safe," Colella says. "The data on side effects is not entirely available for public consumption, but the risk was deemed significant enough by a previous FDA advisory panel to deny Qnexa approval in 2010."
The side effects, which occur in as many as 40 percent of patients, mainly consist of increased heart rate, increased blood pressure, confusion, depression, and birth defects in infants of women who become pregnant while taking Qnexa. Furthermore, Colella says that many taking Qnexa regained the weight they lost during the second year on the drug, and some gained all of the weight back after stopping the treatment.
For Colella, obesity drugs are just another attempt at a "magic bullet" approach to something that we all know really takes a lifestyle change.
"If you can have potato chips and candy with no risk of gaining a few pounds, most of us would indulge. It is simply human nature," he says. "And if you read the fine print, this medication must be prescribed as part of an overall lifestyle change, something our society has not been very good at accomplishing. Physicians are sworn to do-no-harm in caring for our patients, and the prescribing of this drug seems to be not much better than a crap shoot, potentially placing the health and well-being of our patients at risk."
What do you think about this? Would you ever take a prescription diet pill?
Jennipher Walters is the CEO and co-founder of the healthy living websites FitBottomedGirls.com and FitBottomedMamas.com. A certified personal trainer, lifestyle and weight management coach and group exercise instructor, she also holds an MA in health journalism and regularly writes about all things fitness and wellness for various online publications.