Belviq Weight Loss Pill Approved by FDA

The new weight loss pill Belviq (lorcaserin hydrochloride), made by Arena Pharmaceutical’s company has been recently approved by the FDA. This is the first drug for long-term weight loss that has been cleared by the Food and Drug Administration in 13 years. Belviq works by activating the serotonin 2C receptor in the brain which could help you eat less by feeling full longer after small meals. When used with a combination of a balanced diet and exercise, this prescription helps individuals lose about 5% or more of their beginning weight.

According to Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, “Obesity threatens the overall well-being of patients and is a major public health concern. 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 overweight patients who have one other weight-related condition such as high blood pressure, type-2 diabetes or high cholesterol.

Adults who contain a body mass index (BMI) of 27 or higher (overweight) are approved for this drug which should be available in the first quarter of 2013. This is also for adults who are obese with a BMI of 30 or higher.

Approximately 36 percent of adults in America are obese, which is roughly 30 more pounds over a healthy weight. Those extra pounds increase the risk of heart disease, type-2 diabetes, stroke, many other types of cancer, sleep apnea and other debilitating and chronic diseases. There are about 42 percent of adults who are projected to be obese by the year 2030 if something isn’t done to stop the trend.

There were three randomized, placebo-controlled tests that contained approximately 8,000 overweight and obese patients, with and without type-2 diabetes, treated for 52 to 104 weeks. These trials were used to evaluate the efficacy and safety of Belviq. The results show that individuals who took Belviq for at least 12 months had an average weight loss of 3% to 3.7%.

It will be mandatory for the drug’s manufacturer to conduct 6 post-marketing studies, including a long-term cardiovascular outcomes trial to assess the effect of Belviq one the risk for major adverse cardiac events such as stroke and heart attack. The heart function valve of about 8,000 patients was assessed by echocardiography in the Belviq development program.

The FDA says that individuals with congestive heart failure should be cautious when using this medication because it has not been studied in patients with serious valvular heart disease. The Belviq weight loss pill may cause disturbances in memory or attention. The FDA also says that Lorcaserin should not be used during pregnancy.

According to the Food and Drug Administration, there “was no statistically significant difference between lorcaserin and placebo-treated patients.

In 1997, the weight loss drugs fenfluramine and dexfenfluramine were taken from the market after evidence discovered that they caused heart valve damage. The effect is assumed to be related to activation of the serotonin 2B receptor on heart disease. When used at the approved dose of 10 milligrams twice per day, Belviq does not appear to activate the serotonin 2B receptor.

The Belviq weight loss pill has an approved label that recommends patients to discontinue use if they fail to lose 5% of their body weight after 3 months because these patients are unlikely to achieve much weight loss with continued use, says the FDA.

The most common side effects of Belviq in non-diabetic patients include dizziness, headache, fatigue, dry mouth, nausea, and constipation, and in diabetic patients are low blood sugar, back pain, fatigue, cough and headache.

Belviq is manufactured by Arena Pharmaceuticals GmbH of Zofingen, Switzerland and distributed by Eisai Inc. of Woodcliff Lake, N.J.

Source: FDA and USA Today News

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