FDA Approves 2nd Weight-Loss Drug
For the second time in less than a year, the federal Food and Drug Administration has approved a weight-loss drug, Qsymia. The drug was originally known as Qnexa.
In late June, the anti-obesity drug Lorcaserin (Belviq) was approved; it was the first time in 13 years that the agency had given the OK to that kind of drug.
According to FDA guidelines, Qsymia won’t be used for people who want to lose a small amount of weight. Instead, it is approved only for those who have a Body Mass Index (BMI) of 27 or higher, which usually translates to about 20 percent more weight than what is appropriate, and for those with a BMI of 30 or higher, which is considered obese.
In addition, prospective patients must have one weight-related health risk such as diabetes, high blood pressure or high cholesterol. The FDA also said that the drug must be used in conjunction with a program of healthy diet and exercise.
In an FDA release announcing the approval, Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, said, “Obesity threatens the overall well being of patients and is a major public health concern.”
The agency said that the drug cannot be used by pregnant women or patients with glaucoma, hyperthyroidism or recent heart disease or stroke.
Qsymia’s approval was delayed in part because it potentially increases the risk of heart attack or stroke for all those taking the drug.