government
FDA approves weight-loss drug Qsymia
NEWS IN BRIEF — Posted July 30, 2012
The Food and Drug Administration has approved the use of the weight-loss drug Qsymia (phentermine and topiramate) for obese and overweight adults.
The drug is approved for adults with a body mass index of 30 or higher, and adults with a BMI of 27 or higher who have high blood pressure, type 2 diabetes or high cholesterol. The FDA announced the drug’s approval on July 17.
“Obesity threatens the overall well-being of patients and is a major public health concern,” said Janet Woodcock, MD, director of the FDA Center for Drug Evaluation and Research. “Qsymia, used responsibly in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, provides another treatment option for chronic weight management in Americans who are obese or are overweight and have at least one weight-related comorbid condition.”
The American College of Cardiology welcomed the news of the drug’s approval, but also stated the importance of evaluating overall risks and benefits to weight-loss aids. “Weight-loss drugs have the potential to help manage obesity, which is a major health problem, but it is most important to understand the impact the medications may have on long-term cardiovascular health and patient outcome,” said ACC President William Zoghbi, MD.
The drug is marketed by Vivus Inc. in Mountain View, Calif. The FDA has required the company to conduct a trial on long-term cardiovascular outcomes to assess the effect of Qsymia on major cardiac events.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2012/07/30/gvbf0730.htm.
