US regulator approves new drug for weight management
Updated: 2012-07-19 08:38
The US Food and Drug Administration (FDA) on Wednesday approved a new drug, Qsymia, as an addition to a reduced-calorie diet and exercise for chronic weight management.
The new drug is approved for use in adults with a body mass index (BMI) of 30 or greater (obese) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol.
BMI, which measures body fat based on an individual's weight and height, is used to define the obesity and overweight categories. According to the Centers for Disease Control and Prevention, more than one-third of adults in the United States are obese.
"Obesity threatens the overall well being of patients and is a major public health concern," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, who added Qsymia offers another treatment option for chronic weight management in Americans who are obese or overweight and have at least one weight- related condition.
Qsymia, marketed by Vivus Inc. in California, is a combination of two FDA-approved drugs, phentermine and topiramate, in an extended-release formulation. Phentermine is indicated for short- term weight loss in overweight or obese adults who are exercising and eating a reduced calorie diet. Topiramate is indicated to treat certain types of seizures in people who have epilepsy and to prevent migraine.
The most common side effects of Qsymia are tingling of hands and feet, dizziness, altered taste sensation, insomnia, constipation, and dry mouth.