The U.S. Food and Drug Administration today approved Belviq loss pill (lorcaserin hydrochloride), as an addition to a reduced-calorie diet and exercise, for chronic management.
Who Can Use the Belviq loss pill?
The 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 (over) and who have at least one -related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia).
BMI, which measures body fat based on an individual’s and height, is used to define the obesity and over 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, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The approval of this drug, used responsibly in combination with a healthy diet and lifestyle, provides a treatment option for Americans who are obese or are over and have at least one -related comorbid condition.”
How Does Belviq Work?
Belviq loss pill works by activating the serotonin receptors in the brain. Activation of this receptor may help a person eat less and feel full after eating smaller amounts of food.
According to clinical trial data submitted by Arena to the FDA, nearly half of dieters without Type 2 diabetes who used the medication lost at least 5% of their starting — or an average of 12 lbs. — over a year, compared with 23% of those taking a placebo. For best results, dieters are advised to use the medication together with a healthy diet and exercise program.
However, the Belviq loss pill won’t immediately be available for sale. The drug has to go through a four-to-six month process at the Drug Enforcement Administration for a scheduling classification used for drugs that have a likelihood or potential of being abused
Who Should Avoid the Belviq loss pill?
Belviq should not be used during pregnancy. Treatment with Belviq may cause serious side effects, including serotonin syndrome, particularly when taken with certain medicines that increase serotonin levels or activate serotonin receptors. These include, but are not limited to, drugs commonly used to treat depression and migraine. Belviq may also cause disturbances in attention or memory.
In 1997, the -loss drugs fenfluramine and dexfenfluramine were withdrawn from the market after evidence emerged that they caused heart valve damage. This effect is assumed to be related to activation of the serotonin 2B receptor on heart tissue. When used at the approved dose of 10 milligrams twice a day, Belviq does not appear to activate the same serotonin receptor.
How about Qnexa?
Another loss pill called Qnexa is expected to be approved in the next month by the FDA and would be direct competition to the Belviq loss pill.
According to researcher Michael Davidson from the University of Chicago, patients who took Qnexa experienced significant reductions in .
“In this study, Qnexa patients on the top dose had sustained loss greater than 10 percent over two years,” Davidson said. “This loss led to clinically relevant reductions in blood pressure, triglyceride reduction greater than 25 percent and a dramatic increase in HDL levels.”
He added that achieving and maintaining this degree of loss is often difficult for patients, and that these promising results show that the drug could be a good way to improve heart health and cholesterol levels.