WASHINGTON, July 14 (UPI) -- Review documents released by the U.S. Food and Drug Administration indicate the obesity drug Qnexa may be approved, but there are side-effect concerns.
The federal agency acknowledges the drug has met standards for approval, including a reduction in body weight of 5 percent or greater compared with a placebo -- but the FDA has articulated concerns about the cardiovascular, psychiatric and cognitive side effects, Medpage Today and ABC News reported.
However, if the drug by the drug maker Vivus is approved, it will be limited to obese patients who have a body mass index of 30 or more, or overweight patients with a BMI of 27 or higher if they also have high blood pressure, diabetes, dyslipidemia or belly fat.
Included in the review are two randomized, double-blind, placebo-controlled 56-week trials conducted by Vivus and presented at medical meetings, but not yet published in peer-reviewed journals.
Under the low dose, body weight losses were 3 percent or more, while the higher dose resulted in a body weight loss of about 11 percent.
Overall side effect rates were low, but about four to seven times as many patients in the Qnexa studies discontinued the drug due to anxiety, sleep and depression-related adverse events.
In addition, patients reported cognitive-related adverse effects on attention, memory and language, and more reported increases in heart rate relative to those in the placebo group.