FDA makes a risk assesment to approve a new anti-obesity drug. Two new drugs have been approved (first since 1999, Meridia withdrawn due multibillion dollar damages claim) with significant side effects.
FDA approves weight loss drug http://www.foxnews.com/health/2012/07/17/fda-approves-highly-anticipated-anti-obesity-drug/
Qsymia may cause birth defects (pregnancy test required.) and more testing required for heart attack risk.
The Bottom Line on Belviq, Qsymia and Mood Disorders It's not impossible for people who have bipolar disorder or major depression to be treated with either of these drugs, but extremely careful monitoring is necessary. Life-threatening side effects are possible. In some cases, regular blood tests are recommended. Work with your doctors closely if either Belviq or Qsymia is prescribed for you, and make sure you tell them about any changes in mood, sleep, anxiety, stress or physical health. Losing weight is not worth the significant health problems that might occur!
"Diet, exercise and behavioral therapy alone may not result in sustained weight loss for many overweight and obese people trying to lose weight," said Lonnel Coats, President and Chief Executive Officer, Eisai Inc. "BELVIQ represents an important therapeutic option for physicians responsible for the medical management of their patients who are overweight or obese."
In clinical trials, the most common adverse reactions for patients without diabetes treated with BELVIQ were headache, dizziness, fatigue, nausea, dry mouth, and constipation. In patients with diabetes, the most common adverse reactions were hypoglycemia, headache, back pain, cough, and fatigue.
Discovered and developed by Arena, BELVIQ is a serotonin receptor agonist that works by selectively activating the serotonin 2C receptor in the brain and is believed to suppress food intake and promote weight loss. Three double-blind, randomized, placebo-controlled trials demonstrated that BELVIQ along with diet and exercise was more effective than diet and exercise alone at helping patients lose 5% or more of body weight after one year and managing the weight loss for up to two years Being in the GRAS space may turn out to be a good option.
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