With the first new weight-loss drug to be approved in 13 years, dieters have a new weapon against obesity. The first new prescription diet drug in 13 years won Food and Drug Administration (FDA) approval on Wednesday, offering a new alternative to aid weight loss for the nearly one in three Americans who are considered obese. The drug works by controlling appetite — specifically by activating brain receptors for serotonin, a neurotransmitter that triggers feelings of satiety and satisfaction.
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 weight — or an average of 12 lbs. The FDA approved the medication for people who are obese (with a body mass index, or BMI, of 30 or higher) or who are overweight (with a BMI of 27 or above) and also have at least one weight-related health condition such as Type 2 diabetes, high blood pressure or high cholesterol. The most common side effects of Belviq in non-diabetic patients are headache, dizziness, fatigue, nausea, dry mouth and constipation; in patients with diabetes, side effects include low blood sugar, headache, back pain, cough and fatigue.
There was also some concern that Belviq caused tumors in animals and heart-valve defects in people. In 2010, the FDA rejected Arena’s first request for approval, asking for more evidence of its safety. 5 Things You Should Know About Chicken Pox and Shingles6 Breathing Exercises to Relax in 10 Minutes or Less10 Ways to Build Healthy Bones (and Keep Them Strong)13 Reasons Tea Is Good for YouTrue or False? BELVIQ (lorcaserin hydrochloride) tablets are shown in this Arena Pharmaceuticals Inc handout image released to Reuters on June 27, 2012. The Food and Drug Administration approved Belviq last June for adults who are obese or who are overweight and have at least one serious medical condition, such as diabetes or high cholesterol. The drug's launch was delayed for months by logistical hurdles, including classification by the Drug Enforcement Administration.
Because of the delays to its launch, Belviq actually arrives on the market 10 months after competitor Vivus' Qsymia, which launched in September. Arena's studies showed that patients taking Belviq, known generically as lorcaserin, lost just 3 percent to 3.7 percent of their weight over a year.
The FDA said patients should stop taking Belviq after three months if they fail to lose 5 percent of their body weight. Belviq is designed to stimulate serotonin receptors in the brain linked with feelings of satiety, leading patients to feel full.
Qsymia sales have fallen short in part because of limited insurance coverage and high out-of-pocket expenses for patients with coverage. Qsymia also has only been available through mail order, but Vivus said last month the FDA will allow some retail pharmacy distribution. Vivus said batches from the initial production of Qsymia had a shelf life of 24 months, and the company is applying to the Food and Drug Administration to extend that to 36 months for current and future production.
Find out everything you need to know about weight loss drugs in our prescription weight loss pill guide. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. A new pharmaceutical slimming product known as Belviq has been approved by the FDA in the US.
The media is abuzz with news that a new pharmaceutical slimming product known as Belviq has at last been approved by the FDA in the US (Nair, 2013; Perrone, 2012). Dr Ingrid van Heerden is a registered dietician and holds a doctoral degree in Nutrition and Biochemistry.
If you can’t sleep properly on the first night in a new place, rest assured it’s not you, it’s your brain. Serotonin is also involved in mood; many antidepressant drugs work by preventing the reuptake of serotonin and keeping brain receptors bathed in the chemical.
A similar serotonin-based drug that had been approved for weight loss — fenfluramine — was removed from the market in 1997 because of the same heart concerns. New data provided by the company showed that heart problems would not occur at the low doses at which Belviq would be prescribed.
Since 1999, when the last prescription weight-loss medication, Xenical (orlistat), was given the green light, one weight loss drug, Meridia (sibutramine) was taken off the market when users began showing increased risk of heart problems, and two others, Belviq and Qnexa, were rejected by the FDA over safety concerns. At the time, Belviq was the first new drug approved by the FDA for long-term weight loss in more than a decade. According to the drug's label, Belviq will be classified as a Schedule IV controlled substance, which means it has a low potential for abuse. About 47 percent of patients without diabetes lost at least 5 percent of their weight or more, which was enough to meet FDA standards for effectiveness. Patients are unlikely to see any significant weight loss by staying on the drug, the agency said. Food and Drug Administration, a new obesity drug, Belviq, will be available to certain patients by prescription, starting Tuesday.
Food and Drug Administration, a new obesity drug will be available to certain patients by prescription, starting Tuesday.


While these reviews might be helpful, they are not a substitute for the expertise, skill, knowledge and judgement of healthcare practitioners in patient care.Learn more about Belviq.
This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment.
It has been 13 long years since orlistat (Xenical, Alli) was approved by the FDA and in this period most of the other pharmaceutical slimming pills that were available, have been discontinued or banned, leaving obese and overweight patients with only a limited choice. Researchers at Arena say their drug is designed to seek out only the serotonin receptors that affect appetite. For best results, dieters are advised to use the medication together with a healthy diet and exercise program. The FDA won’t require patients taking Belviq to be monitored for heart-valve damage, but the company is required to conduct six studies once the drug reaches the market to determine whether it causes heart attacks or stroke in people  who take it. Manipulating the body’s weight-controlling pathways can have long-term consequences on the heart and other metabolic systems, so drug developers have a high bar to clear to prove their compounds are safe. It’s the first new prescription drug for long-term weight loss to enter US in over a decade. A small segment of patients in company studies reported experiencing euphoria and hallucinations. Under an agreement between the companies, Arena will manufacture and supply the drug from its facility in Switzerland and Eisai will market the drug in the U.S. Analysts have generally been disappointed with Qsymia sales, despite that drug's superior results.
High protein, lots of veggies, some fruit, huge water drinker, no sugar and alcohol on occasion.
Understandably those South Africans who want or need to lose weight, want to be able to purchase Belviq sooner, rather than later.The long waitEver since "legitimate" or pharmaceutical slimming pills such as Reductil were withdrawn from the market in South Africa more than two years ago, individuals who are desperate to lose weight and require some assistance to slim down, have only been able to use orlistat (Xenical or Alli), which prevents the uptake of fat from the diet and thus reduces energy intake leading to weight loss (Nair, 2013). The approved labeling for Belviq also recommends that people discontinue the drug if they fail to lose 5% of their body weight after 12 weeks; longer treatment is unlikely to lead to meaningful weight loss.
As we noted in February, the pharmaceutical industry is desperate for new blockbuster drugs. The delay in availability was in part because the Drug Enforcement Administration needed to review the drug. Despite the good eating and the consistent activity of being a mom of 3 kids, I am about 70 pounds overweight.
Needless to say, there are countless (at least one or more a week) over-the-counter slimming pills and potions that are being launched in South Africa all the time, but the majority of these products either do not contain any active ingredients or do contain potentially harmful components. The patents on their biggest money-making drugs are expiring, which will cause drug prices and profits to plummet when generic versions become available, so the drug-makers are in a frenzy to find a new pill for a mass market. We also do not know how long it will take for this product to be approved by the South African Medicines Control Council (SAMCC) for use in this country.
Belviq, as the FDA pointed out in its statement announcing approval last year, is intended "as an addition to a reduced-calorie diet and exercise." Belviq, or lorcaserin hydrochloride, works by activating a serotonin receptor in the brain, which may help a person eat less and feel full after eating smaller amounts of food, according to the FDA. In other words, if you weighed 200 pounds, you might lose about seven pounds over the course of a year. Belviq received approval about the same time as another weight-loss pill, Qsymia, which hit the market in September. Serotonin is a chemical produced in the brain and other organs of the human body, which affects mood and appetite. Then there are the acknowledged side effects: depression, migraines, memory lapses, and attention disturbances.
A deficiency in serotonin has been linked to manifestations such as depression, low self-esteem, insomnia, panic attacks, eating disorders, anxiety, food cravings and overeating to name but a few. But for some reason, FDA thinks the benefits of taking an expensive pill to lose a tiny bit of weight outweigh the crippling headaches, mental problems, and depression. Patients in clinical trials went from an average 227 pounds to 204 pounds on Qsymia; on Belviq, the average weight dropped from 220 to 207. Various drugs have been developed to increase serotonin levels in the brain to combat the above mentioned symptoms. In trials, 47% of patients without Type 2 diabetes lost at least 5% of their body weight on Belviq, according to the FDA.
That is exactly what they did with another diet drug, Contrave, which has not yet been approved.
Drug giant GlaxoSmithKline was just fined $2 billion because, among other violations, it marketed its antidepressant medications Paxil, Wellbutrin, and Avandia for unapproved uses—particularly for weight loss, even though there is no evidence it would be effective for this purpose. In people with Type 2 diabetes, 38% of patients on Belviq lost at least 5% of their body weight, compared with 16% on a placebo. There is also the added caution that if "5% of weight loss is not achieved by week 12" the drug should be discontinued. It is also worth noting that antidepressant drugs don't even appear to work for depression and can be highly addictive.


At the time of approval, the FDA said Belviq's manufacturer, Arena Pharmaceuticals, would be required to conduct six post-marketing studies, including a long-term cardiovascular trial to assess the risk of heart attack and stroke. Patients, therefore, need to be seriously overweight and afflicted with additional complications of obesity before they can be considered for prescription of Belviq and they are also supposed to reach the goal of losing 5% of their body weight within 3 months to be allowed to continue using this drug.
Someone trying to lose weight is not likely to know about the addiction problem or be told about it. The most common side effects of Belviq in nondiabetic patients included headache, dizziness and fatigue, according to the FDA. An obese patient weighing 100kg would therefore have to lose 5kg in 3 months to stay on the drug.
Oddly, those who lost at least 5% of their body weight using the newly approved Belviq were specifically not patients with Type 2 diabetes—yet the FDA approved it for overweight people with at least one weight-related health condition, such as Type 2 diabetes.
This should basically be an achievable goal, but the question arises if it is necessary to use a drug to achieve this type of weight loss?
Patients with diabetes may experience extra side effects, like low blood sugar, headache, back pain, cough and fatigue.
In addition, some people taking medicines such as Belviq have reported heart valve problems, according to Eisai Inc., which markets the drug. In 2010, FDA denied Belviq’s approval because of potential heart-valve risks and increased brain and breast tumor development. A total of 47.2% of the lorcaserin-treated patients lost at least 5% or more of initial body weight compared with the 25% of placebo-treated patients who achieved a 5% or greater weight loss. Some patients achieved more than 5% losses, with up to 22% on lorcaserin losing 10% or more of their initial body weight compared to 9.7% of the placebo-group (Fidler et al, 2011). In the Blossom trial, the incidence of valvulopathy as detected by serial echocardiograms to track heart valve function, found an identical 2.0% incidence of this disturbance in patients on placebo and patients receiving lorcaserin 10mg twice daily (Fidler et al, 2011). An FDA drug advisory panel has already recommended approval of one of them, Qnexa, a diet pill that has documented risks of causing birth defects and heart problems.
Clinical and pharmacovigilance studies with longer study duration are need to inform of the long-term efficacy and safety of lorcaserin".ConclusionsIt would seem that lorcaserin or Belviq does hold promise for modest to good weight loss ranging from 5 to 10% of body weight when combined with an energy-reduced diet and exercise. South African slimmers will, however, have to wait until this drug has been approved by the SAMCC, so a great of patience will be required. The only other currently FDA-approved weight loss drug is Alli, which has particularly nasty side effects like oily stools and flatulence—not to mention causing vitamin deficiencies and possible liver damage.
In the meanwhile, obese or overweight patients should consider using balanced energy reduction and exercise (as approved by your physician especially if you suffer from one or more of the so-called comorbidities of obesity) to work towards your goal of weight loss. Efficacy and safety of lorcaserin in obese adults: a meta-analysis of 1-year randomized controlled trials (RCTs) and narrative review on short-term RCTs. One recent randomized, double-blind study points to the potential of unroasted coffee bean extract. The extract contains chlorogenic acid, which helps tame blood sugar spikes and decrease weight. A one-year randomized trial of lorcaserin for weight loss in obese and overweight adults: the BLOSSOM trial. Best of all, 37% of the patients using coffee extract went from overweight (the pre-obesity range) back to their normal weight range. Other studies show that drinking twelve cups of coffee a day lowers the risk of diabetes by 67%. But few of us can (or should) drink that much coffee each day, so research into a coffee extract is extremely promising indeed. Randomized placebo-controlled clinical trial of lorcaserin for weight loss in type 2 diabetes mellitus: the BLOOM-DM study. Unfortunately, green coffee bean extract and other nutraceuticals are always vulnerable to a rapacious drug industry that might want to turn such natural substances into drugs.
This is what precisely happened to pyradoxamine and could happen to P5P, the most bioavailable form of vitamin B6.
The only barrier to this theft under FDA rules is that pharmaceutical companies prefer to rely on synthetic versions of natural substances because they can be patented, and the companies can then charge whatever they wish. Attribution To ANH-USA.ORG The information in Pulse of Natural Health is for educational purposes only and should not be construed as medical advice. Readers are advised to consult a qualified professional about any issue regarding their health and well-being.



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