Despite a spate of concerns about potential birth defects, the government is still weighing whether to allow the pending approval of the new obesity drug Qnexa for treatment of the condition.
Currently, few options for medication to help overweight and obese patients shed excess weight exist, with many of the drugs used for dieting either banned or heavily restricted. Lap bands and gastric bypass surgery have become more common in recent years, but both procedures are invasive and not without risk. And the problem of obesity in America continues to worsen, with two-thirds of the population of adults in America classified as overweight or obese- meaning that any drug that comes to market will potentially be used by millions of Americans seeking a more efficient way to lose weight.
Qnexa was developed by Vivus, a combination of weight loss drug phentermine and migraine medication topiramate, or Topamax. Already, doctors have been prescribing the combination of drugs that make up Qnexa together, off-label- but use of the latter drug has been linked to a two to five times increase in instances of cleft lip in babies born to mothers using the medication, according to the New York Times. Phentermine is also linked to some cardiovascular concerns.
However, the question is whether the risks of the drug therapy outweigh the benefits. Drugmaker Vivus addressed the positive outcomes of bringing Qnexa to market:
“The ability of Qnexa to produce durable weight loss can be expected to contribute significantly toward ameliorating some of the consequences of obesity and weight-related comorbidities.”
The FDA countered:
“Over all, the long-term clinical impact of the observed modest improvements in comorbidity outcomes is uncertain, particularly in a population with higher risk of CV adverse events.”
The FDA is expected to revisit the obesity drug again Wednesday to consider its approval.