In the first half of 2012 the FDA advisory committee recommended two new diet pills for approval. Both drugs, Qsymia (formerly Qnexa) and Belviq (lorcaserin) have since been approved. Before this, no new prescription weight loss diet drugs had been approved in thirteen years. This is welcome news for the millions of Americans who are seriously overweight or clinically obese.
Indeed, the statistics regarding the prevalence of obesity in Americans are not encouraging. The 2010 CDC National Health and Nutrition Examination Survey reveals that:
Obesity not only raises the risk of diabetes, hypertension, stroke and heart attack, but, according to the Centers for Disease Control (CDC), costs the US economy approximately $147 billion per year in medical expenses and lost productivity (source: Bloomberg News ).
Beyond diet and exercise, clinicians were previously left with few medical, non-surgical options for the treatment of obesity.
Bariatric surgery, which while successful in some patients, can be associated with serious adverse events, and the results are not necessarily long term.
Lapband adjustable gastric band is associated with operative mortality and complications including band slippage, erosion, etc.
All of which explains why this is encouraging news for obese Americans yearning for new diet medicine options, and why the marketplace is buzzing about Qsymia and Belviq.
Qsymia is a combination of two existing FDA-approved drugs, Topamax (topiramate) and phentermine. Topiramate is currently prescribed to treat epileptic seizures and headaches,
while phentermine is approved for short-term use as a diet medicine based on its ability to suppress hunger.
Long-term studies of the new diet pill, Qsymia, have shown significant weight loss as well as positive effects on quality of life and cardiac risk factors with the potential to
lower cholesterol and blood pressure. In addition, the magnitude of weight loss seen with Qsymia was reasonably comparable to that of the Lapband.
In approving Qsymia, the FDA appears to have felt that the benefits from the weight loss and reduced risk factors more than offset the potential side effects, which include the chance of birth defects and cognitive problems with Topamax, and heart problems associated with the stimulant effects of phentermine.
Patients can also take phentermine and topiramate together, prescribed by their physician off label.
Off label use means that a medication is being prescribed for a purpose other than that for which it was approved by the FDA. While pharmaceutical manufacturers cannot promote off-label use of its drugs, it is a relatively common – and legal – practice among physicians who recognize the alternate benefits a drug can offer patients. Physicians should inform their patients that the medications they are using are being prescribed off label.
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Another diet pill approved by the FDA, Belviq (lorcarserin) is sanctioned, in combination with a program that includes a healthy diet and exercise, as prescription therapy for long-term weight loss for adults who are obese or significantly overweight.
Lorcaserin has serotonergic properties, acting on receptors in the brain, resulting in reduced appetite by boosting feelings of satiety and fullness.
In 2010, lorcaserin was initially rejected due to safety concerns regarding heart-valve problems and evidence that it may cause tumors in rats. In approving the drug, the FDA expressed satisfaction that it was unlikely to cause heart valve problems. The FDA also felt there was little risk of tumors in humans.