The Food and Drug Administration has approved a new weight loss drug, the first in the U.S. market in over 13 years. The last weight loss drug, Orlistat (or generically Xenical), was approved in 1999 and worked by preventing the absorption of fats from the diet. On Wednesday the FDA approved the anti-obesity drug, Belviq (or generically lorcaserin). Arena Pharmaceuticals attempted to have the drug approved in 2010, but scientists found tumors in animals taking the drug. After some additional data was resubmitted, clinical studies in humans found the drug to be safe with no concern of tumors. Typical side effects include depression, migraines, and memory lapses. It is expected to hit the market some time next year.
The FDA has approved the drug, Belviq, for weight loss. It is expected to hit the market in 2013. It is the first weight loss drug to be approved in the U.S. in over a decade.
With nearly 2/3 of the U.S. population being overweight or obese, the obesity epidemic in this country is staggering. The drug allows doctors to prescribe a drug marketed for obese individuals (BMI of 30 or above) or overweight individuals (BMI of 27 or higher) who also present at least one comorbid condition related to obesity (such as type 2 diabetes, high blood pressure, or high cholesterol). It is not meant to be used alone, however. Patients should use the drug to supplement a healthy diet, regular exercise, and an active lifestyle. Arena Pharmaceutical performed three randomized-control clinical trials consisting of over 8,000 participants (diabetic and non-diabetic) lasting over 1-2 years. Belviq showed moderate weight loss. Patients lost an average of 3-3.7% of their starting weight over the course of a year. Nearly 47% of diabetic patients lost an average of 5% of their starting weight, making it an effective weight loss tool for the FDA’s standards. However, if individuals don’t see any significant weight loss in the first three months, it is unlikely that they will have beneficial results by continuing to stay on the drug. The company is required by the FDA to conduct six more postmarketing studies to assess the drugs cardiovascular safety and the risk of stroke and heart attack.
How does the drug work? The drug works by altering chemical signals in the brain that control appetite and hunger. Belviq triggers the receptors for the neurotransmitter, Serotonin, which triggers feelings of fullness and satiety. Taking Belviq can make a person feel fuller after eating smaller amounts of food, leading to a calorie deficit and eventual weight loss. The drug works similar to the biochemical process that makes anti-depressants so effective – they prevent the reuptake of specific neurotransmitters.
Are weight loss drugs the answer to America’s obesity problems? Absolutely not. Unfortunately, however, this is the mentality of many people who are prescribed a weight loss drug. Patients believe that this “magic pill” will suddenly melt the fat off their body and they can continue to eat and do whatever they want without putting in any work. Therefore, the public needs to be educated on how to properly manage their weight with proper diet and exercise…and this is where dietitians come in! I also think diet pills can be beneficial for people who have been “yo-yo” dieting their whole life. Individuals will try to lose weight for a short amount of time, and when they don’t see the results they want, they give up and go back to their old habits. By “failing” at their weight loss goals, the lose their confidence in their ability to shed the pounds. I think this is where anti-obesity drugs can be the most effective. For people who have lost their confidence, a drug may spark some weight loss. When patients see such positive results, they will begin to gain back the self-efficacy needed to maintain sufficient weight loss. Eventually (and hopefully) people will learn to wean off the drug and be able to maintain their weight on their own…not to mention properly manage comorbid conditions like diabetes, hypercholesterolemia, and high blood pressure.
For more information on Belviq, check out the FDA report at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm309993.htm.