New Obesity Drug Qnexa Awaiting FDA Approval
The U.S. Food and Drug Administration released review documents indicating that a new obesity drug, Qnexa may get approval, but it has a few side-effect concerns. The drug has met the standards for approval as per by federal agency. This includes a
reduction in the body weight of 5% or more
when compared with a placebo. Read on to know more about the new obesity drug,
On the contrary, FDA has raised concerns about the cognitive, psychiatric and cardiovascular side effects as reported by ABC News and Medpage Today. But if the drug is approved, which is manufactured by Vivus, it will be limited to those obese patients who have a body mas index (BMI) of 30 or greater. Also, it can be used for those patients who are overweight with a BMI of 27 or greater and also have belly fat, dyslipidemia, diabetes and high blood pressure.
The Placebo Study
Two double-blind, randomized 56 weeks trials were conducted by the drug maker Vivus which was presented at various medical meetings. While studying the low dose effects, it was observed that 3% more body weight loss occurs. On the other hand, with higher dose helped in 11% of body weight loss.
Side Effects of the Drug
The side effects were very low. But many patients
discontinued the drug for about 4-7 times due to depression, sleep and anxiety related events
. Additionally, a few of the patients reported adverse effects related to cognitive behavior such as language, memory and attention. Compared to the placebo group, more patients reported an increase in their heart rate.