FDA Approves Weight-Loss Pill Qsymia
New York: The US Food and Drug Administration (FDA) approved Vivus Inc`s obesity drug, Qsymia, on Tuesday, giving a new hope to people fighting excessive weight gain problem.
The approval follows last month`s go-ahead for Arena Pharmaceuticals` Belviq.
The FDA had previously delayed its decision on the weight-loss pill by three months to review the company`s plan for reducing risks, such as birth defects and elevated heart rate.
With about two-thirds of Americans considered obese, the FDA has been under constant pressure to approve new weight loss treatments.
The FDA approved the pill for use in obese adults, and in overweight adults who have at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol.
"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," Dr. Janet Woodcock, director of FDA`s Centre for Drug Evaluation and Research, said in a statement.
Despite the approval, Vivus will still have to carry out a lengthy study to prove that the drug does not cause heart attacks or strokes.
The side effects of the new weight-loss pill includes tingling of hands and feet (paresthesia), dizziness, altered taste sensation, insomnia, constipation and dry mouth.