FDA’s drug center, said in a statement. “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 overweight and have at least one weight-related comorbid condition.” In studies sponsored by Arena, about half of patients taking Belviq lost about 5 percent of their body weight after a year. The most common side effects include headache, dizziness, fatigue, nausea, dry mouth, and constipation. Because preliminary data suggest that the number of serotonin 2B receptors may be increased in patients with congestive heart failure, Belviq should be used with caution in patients with this condition. Belviq has not been studied in patients with serious valvular heart disease.
The FDA had rejected the drug in 2010 after a panel of experts advised the agency to give it a thumbs down because of safety concerns. Early studies indicated the drug might cause tumors in rats and possibly heart problems in people. Lorcaserin works the same way as one part of the fen-phen diet pill combination that was pulled from the market in 1997 because it caused heart valve damage.
But the company submitted new data aimed at alleviating those concerns, and the same panel endorsed approval in May. Some panel members, however, again expressed concerns about the drug’s safety, especially the heart problems, as have some consumer advocates.
“Faced with this serious concern, it would be dangerous and unconscionable for you to allow the FDA to disregard the available evidence and subject large numbers of obese patients, already at risk for cardiovascular disease, to the added risk of damaged heart valves,” wrote Sidney M. Wolfe of the Public Citizen Health Research Group, in a letter to FDA Commissioner Margaret A. Hamburg.
Despite millions of dollars in research, only a handful of government-approved weight loss drugs are on the market, and only one, Orlistat, can be used long-term. The FDA hasn’t approved a new weight lloss drug since Orlistat came on the market in 1999. Although it’s now available without a prescription under the name Xenical, that drug isn’t all that effective and can cause unpleasant side effects, most notably diarrhea. The once-popular weight loss drug Meridia was pulled from the market in 2010 because of concerns about heart attacks and strokes. In February, FDA advisers also recommended approval of Qnexa, another weight loss drug. The FDA had rejected Qnexa in 2010 because of concerns about heart problems and birth defects. But Vivus, maker of Qnexa, submitted additional data aimed at alleviating those concerns. In April, the FDA said it was delaying a final decision on Qnexa until July 17. Qnexa is a combination of two drugs that are already on the market: phentermine, a stimulant used for short periods to help control weight, and topiramate, which is used for migraines and seizures.”
Heal n Cure’s remarks
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INSPIRE – ‘Core Wellness’ Program
Results of a retrospective chart study of more than 100 patients over an average duration of 6 months. Ninety eight percent of patients lost an average of more than 20 lbs,. BMI decreased an average of about 10%. The body’s lean mass composition improved by 10%.
The Inspire program is effective in achieving a level of weight reduction that preserves lean mass and is correlated with a significant decrease in the incidence of type 2 diabetes, cardiovascular disease and other obesity-related co morbidities. The success of the program is likely related to its unique multidisciplinary approach that incorporates proven evidence-based strategies into practical medical management.