Millions of obese Americans are unable to achieve sustainable weight loss through diet and exercise alone, yet are unable to receive bariatric surgery, or would be better suited to a less extreme option than surgery. We have on-going hope that this gap in obesity treatment could potentially be filled by an anti-obesity drug. However, the FDA has not approved a drug to treat obesity in 13 years. Currently, the only drug approved for long-term weight loss in the U.S. is Orlistat, which is sold as the prescription drug Xenical and over the counter as Alli. Orlistat has not gained much traction though, because it has unpleasant side effects, often causing diarrhea. But there could be another treatment option in the near future: this month, the FDA’s Advisory Committee came to a nearly unanimous vote to recommend the approval of QNEXA, a new drug to treat those affected by obesity. QNEXA, made by Vivus, is a combination of phentermine (which suppresses appetite) and topiramate (which increases feelings of fullness). It has been shown to produce a weight loss of roughly 10 percent of body weight over a year or two in clinical trials, and does outperform placebo.
Qnexa was rejected by the FDA committee in 2010 with a 10 to 6 vote against approval by the same panel. This year, however, the members agreed that the health risks of obesity and the benefits of losing weight outweighed the risks posed by the drug, and voted to recommend approval of QNEXA, 20 to 2. The previous rejection was largely because of concerns over the potential for heart problems, birth defects and mental effects, including lack of concentration and fogginess. Vivus has made plans to minimize those risks through measures like labeling and an additional trial to investigate cardiovascular side effects. Some experts, however, are still very concerned with the side effects, as the drug will likely be sought by millions of Americans. Other experts feel that this is a step in the right direction in addressing the serious consequences of the obesity epidemic. The FDA is expected to make a final decision on the request to approve QNEXA in the next couple of months.
While there has been difficulty finding an acceptable drug to treat obesity, research has found weight loss surgery to be a very effective treatment for obese people with a BMI as low as 30 for the gastric band. You can learn more about our program at Oregon Weight Loss Surgery here.