FDA approves a device for weight loss. Marketing of an implantable device that manipulates appetite signals passing between the brain and gut. An implantable device for weight loss wins the FDA's blessing. Marketing of an implantable device that stimulates weight loss by manipulating key appetite signals passing between the brain and the gut. While the FDA has approved four medications for weight loss in the past 2 1/2 years, the Maestro system is the first weight loss device to be approved since 2007. The FDA approved the use of the device in adult patients with a body mass index, or BMI, between 35 and 45, who have at least one other obesity-related condition, such as type 2 diabetes . Delivered by the Maestro device, vagal blocking therapy, or VBLOC, offers obese patients a weight loss therapy that does not permanently alter the digestive system in the way that gastric bypass surgery does, and which may be less expensive, said Lea. In a 12-month clinical trial considered by the FDA, 38.3% of subjects who received the active Maestro device lost at least a quarter of their excess weight, and 52.5% of subjects lost at least 20% of their excess weight. Researchers testing the device also observed that, like bariatric surgery, it might have beneficial effects that go beyond weight loss. Suppressing signals between gut and brain on the vagus nerve appeared to improve the metabolic function of obese patients who got the device. "You actually see the effect before patients actually have had that much weight loss," said Dr. Ken Fujioka, a Scripps Institute endocrinologist and weight management expert who conducted some of the studies that led to the Entero Medics device. That suggests that the device may be especially beneficial for those who have developed obesity-related type 2 diabetes, he said. As a result, said Lea, the Maestro device appears to be safe and effective for long-term use, and unlike surgical alterations to the digestive system, reversible.
Belviq, the first weight loss pill approved by the FDA in 13 years, works by activating a receptor in the brain that helps people feel full after eating. Federal Food and Drug Administration officials approved a new weight-loss pill Wednesday, giving the nod to Belviq used in combination with a reduced-calorie diet and exercise to combat obesity. The Arena Pharmaceuticals drug, which also goes by the generic name lorcaserin, is one of three new potential weight-loss treatments the agency is considering and the first new weight-loss medication approved in 13 years. Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research. The drug was tested in three randomized, placebo-controlled clinical trials involving nearly 8,000 obese and overweight patients, including those with and without type 2 diabetes. Compared with use of a placebo, or sugar pill, patients treated with Belviq for up to one year lost an average of 3 percent to 3.7 percent of their body weight. Nearly half of patients without diabetes lost at least 5 percent of their body weight, compared with about a quarter of those who took placebos. In people with diabetes, about 38 percent treated with lorcaserin lost 5 percent of their body weight, compared with about 16 percent treated with placebos. Approving lorcaserin will offer big benefits to patients approaching the 30 BMI mark, which increases health risks and decreases the likelihood of future weight loss, said Dr.
Food and Drug Administration today approved Qsymia (phentermine and topiramate extended-release) as an addition to a reduced-calorie diet and exercise for chronic weight management. “Qsymia, used responsibly in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, provides another treatment option for chronic weight management in Americans who are obese or are overweight and have at least one weight-related comorbid condition.” The safety and efficacy of Qsymia were evaluated in two randomized, placebo-controlled trials that included approximately 3,700 obese and overweight patients with and without significant weight-related conditions treated for one year. The recommended daily dose of Qsymia contains 7.5 milligrams of phentermine and 46 mg of topiramate extended-release. Qsymia is also available at a higher dose (15 mg phentermine and 92 mg of topiramate extended-release) for select patients. Results from the two trials show that after one year of treatment with the recommended and highest daily dose of Qsymia, patients had an average weight loss of 6.7 percent and 8.9 percent, respectively, over treatment with placebo. Approximately 62 percent and 69 percent of patients lost at least five percent of their body weight with the recommended dose and highest dose of Qsymia, respectively, compared with about 20 percent of patients treated with placebo. Patients who did not lose at least three percent of their body weight by week 12 of treatment with Qsymia were unlikely to achieve and sustain weight loss with continued treatment at this dose. If after 12 weeks on the higher dose of Qsymia, a patient does not lose at least five percent of body weight, then Qsymia should be discontinued, as these patients are unlikely to achieve clinically meaningful weight loss with continued treatment. Therefore, the use of Qsymia in patients with recent (within the last six months) or unstable heart disease or stroke is not recommended. Regular monitoring of heart rate is recommended for all patients taking Qsymia, especially when starting Qsymia or increasing the dose. The purpose of the REMS is to educate prescribers and their patients about the increased risk of birth defects associated with first trimester exposure to Qsymia, the need for pregnancy prevention, and the need to discontinue therapy if pregnancy occurs.
The agency on Tuesday approved Saxenda (liraglutide) for adults who are obese or for those who are overweight and have at least one weight-related health condition, such as high blood pressure, type 2 diabetes or high cholesterol. Patients taking the drug, made by Novo Nordisk, should still follow a low-calorie diet and exercise regularly, the FDA noted. Three clinical trials assessed the safety and effectiveness of the drug for weight loss. Of the people treated with the drug, 62 percent lost at least 5 percent of their body weight. The FDA added that patients should be examined to determine if Saxenda is working after 16 weeks of treatment. Those who do not lose at least 4 percent of their body weight by that time should stop taking the medication, the FDA said. Patients who experience a prolonged increase in their resting heart rate should stop taking Saxenda, the FDA added. Tumors of the thyroid gland were associated with Saxenda treatment in rodent studies. Patients who have been diagnosed with MTC or have a family history of the condition should not take Saxenda. Patients with a condition known as multiple endocrine neoplasia syndrome type 2, which increases the risk for MTC, should also not take Saxenda, the agency said. The FDA has also required that additional studies involving Saxenda investigate the safety and effectiveness of the drug in children, including how it could affect growth and development. Ongoing clinical trials are also examining the possible risk of breast cancer associated with Saxenda.
11, 2014 - The FDA's approval on Wednesday of a new prescription weight loss pill offers yet another option for the more than one-third of American adults who are obese. Called Contrave, the new drug is the third prescription weight loss drug to be approved by the FDA since 2012. Contrave combines two drugs already on the market: bupropion ( Wellbutrin ), an antidepressant , and naltrexone , an anti- addiction drug. Weight loss experts say all three drugs work in similar ways, but they welcome Contrave as yet another option, especially since not all weight loss drugs work the same for everyone. The FDA approval came after the agency looked at new information it requested from the drug's maker in 2011 to be sure the drug was safe for the heart . How the combination works for weight loss is not entirely understood, even by experts.
Orlistat (Xenical) the most commonly used medication to treat obesity and sibutramine (Meridia) a medication that was recently withdrawn due to cardiovascular side effects.  The main treatment modalities for overweight and obese individuals remain dieting and physical exercise . Because of potential side effects , it is recommended that anti-obesity drugs only be prescribed for obesity where it is hoped that the benefits of the treatment outweigh its risks. Current and potential anti-obesity drugs may operate through one or more of the following mechanisms: It was not until the 1920s and 1930s that new treatments began to appear.  Fen-phen was born and rapidly became the most commonly prescribed diet medication. Dexfenfluramine (Redux) was developed in the mid-1990s as an alternative to fenfluramine with less side-effects, and received regulatory approval in 1996. Ephedra was removed from the US market in 2004 over concerns that it raises blood pressure and could lead to strokes and death. Food and Drug Administration (FDA) has approved a revised label for Xenical to include new safety information about cases of severe liver injury that have been reported rarely with the use of this medication. In the past, it was noted by the US that Meridia was a harmless drug for fighting obesity. The combination of phentermine and topiramate , brand name Qsymia (formerly Qnexa) was approved by the U. Unresearched nonprescription products or programs for weight loss are heavily promoted by mail and print advertising and on the internet.  A similar medication designed for patients with Type 2 diabetes is Acarbose; which partially blocks absorption of carbohydrates in the small intestine, and produces similar side effects including stomach pain and flatulence. The limitation of - or knowledge gap concerning - drugs for obesity is that we do not fully understand the neural basis of appetite and how to modulate it. This was a novel combination of an inhibitor and a polymer designed to bind the undigested triglycerides therefore allowing increased fat expulsion without side effects such as oily stools that occur with orlistat.
However, I am concerned that mass marketing of this drug will perpetuate the magic bullet approach to weight loss, which is limiting and does not address the root problem," said Dr. "I think it's clear from current research that there are problems with weight-regulating mechanisms in the brain that make it difficult for people to lose and maintain weight," said Dr. She said she was the quintessential jock in high school and college: physically active, involved in sports and always staying fit and trim. Evans said she tried several diets over the years and continued to stay active, playing goalie for her soccer team. I was not OK with that," she said. Her doctor recommended that she enroll in the clinical trials for Qsymia, and she readily agreed. She started taking the drug in February 2008 and also worked with a counselor once a week to develop a diet and exercise plan. She said the only noticeable effect of the drug was that it decreased her hunger pangs. Vivus emphasizes that the drug is intended to be used in combination with diet and exercise. However, studies of Belviq found that patients lost about 4 percent of their body weight, compared with the 10 or 12 percent lost by Qsymia patients. She said the gain is due in part to an injury to her Achilles tendon that has kept her from being as active as she was.
Prescription Weight Loss / Diet Pills: What Are the Options? Prescription weight loss pills, also called anti-obesity drugs or “diet pills”, are sometimes prescribed to a patient as an additional tool in the treatment for weight loss . Weight loss drugs should not be used as a substitute for healthful eating and a regular exercise program. Most weight loss drugs that suppress the appetite are known as anorexiants . Common "Diet Pills" or Weight Loss Drugs. How Effective are Weight Loss Drugs? Weight loss drugs may not work for everyone. Who are Candidates for Weight Loss Drugs? However, prescription weight loss drugs should be used in addition to diet and exercise. Weight loss drugs should not be used during pregnancy. All weight loss drugs fall under pregnancy category X and are contraindicated in pregnancy.
Weight-loss drug Contrave wins FDA approval on second try. The FDA gave a green light to Contrave, the third weight-loss drug to win approval from the agency. New diet drug Contrave is to be used along with reduced-calorie diet and physical activity, FDA says. Food and Drug Administration announced the approval Wednesday of the new weight-loss drug Contrave, a mix of antidepressant and alcohol dependence medications. Of La Jolla, combines the drugs naltrexone, which is used to treat alcohol and opioid dependence, and the drug bupropion, which is prescribed for depression, seasonal affective disorder and smoking cessation.
Qsymia is the first weight loss drug approved by the FDA in 13 years. Eva Cwynar says the drug “makes the stomach feel like it’s got enough food in there.” The drug is now available at retail pharmacies by prescription. “When I gained all the weight. This year, he finally decided that he wanted to lose the weight for good. They worked out a diet and exercise plan and used a new tool that recently became available - the first weight loss drug approved by the FDA in 13 years - called Qsymia . Cwynar said, “It makes the stomach feel like it’s got enough food in there.” “Normal Phenteramine on the market is 37 milligram, this has a 3 milligram as a starter dose. So it’s a fraction of what’s out there, and it doesn’t have the agitation, or the cardiac effects,” Dr. “The majority of patients that I put on this drug have absolutely no side effects.” Brown says he has felt no side effects from the drug at all. “I feel rejuvenated, and I’m off in a whole new direction,” he said, “I’m excited for the new direction of life.”
For the third time in about two years, the Food and Drug Administration has approved a new weight loss pill. FDA approves a third new weight-loss pill For the third time in about two years, the Food and Drug Administration has approved a new weight loss pill. To find out more about Facebook commenting please read the Conversation Guidelines and FAQs. FDA has approved a new weight loss pill, the third in about two years. For the third time in about two years, the Food and Drug Administration has approved a new weight-loss pill. All of the new drugs work by decreasing appetite and all have some side effects and drawbacks, though they differ. In Belviq's studies for the FDA, average losses were 3% to 3.7% over placebo; for Qsymia, average losses were 6.7% to 8.9% over placebo. "The ideal candidate for a drug to treat obesity is someone who uses the drug as a tool, along with diet and exercise," says Tsai, who has no ties with drug makers. Adults, 78.6 million, are obese, according the federal Centers for Disease Control and Prevention. Patients filled about 138,000 prescriptions for Qsymia in the second quarter of 2014, according to drug maker Vivus Inc. Prescription numbers for Belviq were about 110,000 in the same period, according to Arena Pharmaceuticals Inc., which makes the drug. That's a lot of room for growth, he says, and having a third drug approved just "gets more voices out there" talking about the pharmaceutical options. In the past, some obesity drugs have been linked to serious heart problems and pulled from the market. The makers of Contrave, Belviq and Qsymia have all agreed to conduct long-term heart safety studies and report the results to FDA.
Meg Evans, in red, lost 48 pounds her first year on Qsymia and another two pounds the second year. Qsymia (pronounced kyoo-SIM-ee-uh) is the second diet drug approved this year. On Qsymia, patients went from an average 227 pounds to 204 pounds; on Belviq, the average weight dropped from 220 to 207. Doctors are free to prescribe the drug to anyone, however, and there are concerns that physicians will open "pill mills" and prescribe Qsymia to people who just want to lose a few pounds. The 4,430 overweight and obese patients in the Qsymia studies experienced various levels of weight loss. Meg Evans, one of the patients, started out at 230 pounds and lost 48 pounds her first year on the drug and another two pounds the second year. An avid cook and eater, she said the drug made it easier to resist tempting foods. She said the weight came off gradually, about four pounds a month, and her blood pressure went down almost immediately. The FDA and Vivus both acknowledge that the three clinical trials meant to measure Qsymia's safety and effectiveness were not designed to properly assess cardiovascular risk. Evans, the patient who lost 50 pounds on the drug, said she has gained back about 20 pounds since the clinical trial ended two years ago and looks forward to going on Qsymia once it's approved, even though it can have side effects. She added that the drug wasn't the only reason she lost weight.
Food and Drug Administration has approved the diet drug Qsymia, the agency's latest move to give doctors and their patients more tools to fight excessive weight gain as obesity rates continue to bulge in the U. Data presented by the company showed that it helped patients lose about 10 percent of their body weight. However, I am concerned that mass marketing of this drug will perpetuate the magic bullet approach to weight loss, which is limiting and does not address the root problem," said Dr. "I think it's clear from current research that there are problems with weight-regulating mechanisms in the brain that make it difficult for people to lose and maintain weight," said Dr. She said she was the quintessential jock in high school and college: physically active, involved in sports and always staying fit and trim. Evans said she tried several diets over the years and continued to stay active, playing goalie for her soccer team. I was not OK with that," she said. Her doctor recommended that she enroll in the clinical trials for Qsymia, and she readily agreed. She started taking the drug in February 2008 and also worked with a counselor once a week to develop a diet and exercise plan. She said the only noticeable effect of the drug was that it decreased her hunger pangs. Vivus emphasizes that the drug is intended to be used in combination with diet and exercise. However, studies of Belviq found that patients lost about 4 percent of their body weight, compared with the 10 or 12 percent lost by Qsymia patients. She said the gain is due in part to an injury to her Achilles tendon that has kept her from being as active as she was.
The FDA has declined to approve the investigational weight-loss pill Qnexa, doses of the new drug, compared with 10 percent of patients taking placebo. Before these two new drugs, the last prescription weight-loss pill to be. The new pill, formerly known as Qnexa (the FDA asked Vivus to . The weight loss pill Qsymia is now for sale from certified online to Vivus Pharmaceuticals - is the first new weight loss drug to reach market in. Vivus chose the name Qsymia after the FDA rejected a previous name, Qnexa. Qsymia, Qnexa, weight loss drug, obesity pill. The product will be sold under a new name, Qsymia. Nov 3, 2011, FDA Accepts New Drug Application Filing for Qnexa. New weight loss drug qnexa. Qnexa® is the brand name of the medication produced by Vivus. Qnexa is a combination drug of topiramate and phentermine being studied for the treatment of obesity. There is a study that reveals the similarities of Qnexa / Qsymia to other prescription weight loss pills and that they can increase the chances of heart attacks and.
The panel of Food and Drug Administration advisers voted 14-1 that the injectable drug’s benefits outweigh it risks for patients who are obese or dangerously overweight. The FDA first approved the drug, liraglutide, under the brand name Victoza in 2010 as a daily injection for type 2 diabetes, in which the body does not properly use insulin. Danish drugmaker Novo Nordisk now wants the FDA to approve the drug as an obesity treatment based on company studies showing significant weight loss in most patients. Sixty percent of patients taking the drug for over a year lost at least 5 percent of their body weight, and 31 percent of patients lost more than 10 percent, according to the company’s research. If approved, Novo Nordisk plans to market the drug under a new brand name, Saxenda. It would be the first injectable drug approved for weight loss. The FDA panel recommended approving the drug for patients who have a body mass index of 30 or higher, which is the level at which people are considered to be obese. Earlier Thursday the FDA approved the long-delayed weight loss pill, Contrave, from Orexigen Therapeutics Inc.
FDA Approves New Weight-Loss Drug Contrave. Regulators are greenlighting a new weight-loss drug called Contrave, the third in a string of approvals for anti-obesity treatments. The Food and Drug Administration said Thursday that it is approved for use by people who have a body mass index of 30 or higher, which is considered to be obese, and for people with a BMI of 27 or higher who also have a weight-related medical condition such as diabetes. Contrave is a combination of two drugs that are already approved, naltrexone and bupropion. The combination pill joins two similar drugs from Arena Pharmaceuticals and Vivus Inc., which FDA approved in 2012 after a 13-year drought of new prescription weight-loss medicines. Patients on Contrave for a year lost 4.2 percent more weight than patients taking a dummy pill.
On Tuesday, the Food and Drug Administration ( FDA ) approved Qsymia, the second new diet drug in a month, and the most effective of the weight-loss pills that the agency has considered in recent years. (MORE: A Brief History of Diet Pills and the FDA ) The drug is approved for obese adults with a body mass index, or BMI, of 30 or higher. Some doctors have already been prescribing the two drugs together for weight loss. In clinical trials, overweight and obese patients taking Qsymia for a year lost differing amounts of weight: on average, patients taking a middle dose of the drug lost 8.4% of their body weight; on a higher dose, patients lost 10.6%. Most of the weight came off in the first three months, so doctors should monitor patients at that point to see if the drug is working. The FDA notes that people who don’t lose at least 3% of their body weight by three months are unlikely to go on to lose any significant weight, so they should either be counseled to discontinue the drug or to try a higher dose (Qsymia will be available in two doses). If patients still don’t lose at least 5% of their weight after three additional months on the higher dose, they should quit taking Qsymia. The drug is designed to be used in conjunction with traditional weight-management strategies like diet and exercise. Doctors stress that because of the potential risks of the drug, dieters should not use the drug for cosmetic weight loss. It will also be available in specialized pharmacies that register for the right to sell the drug, where pharmacists have been educated about Qsymia’s risks and can pass that information along to patients and doctors. Safety concerns led the FDA to reject Qsymia’s first bid for approval in 2010, but the agency and Vivus have now put in place strategies to reduce risk: for example, women of child-bearing age who want to take Qsymia must test negative for pregnancy before starting the drug and are expected to use contraception and take a pregnancy test once a month while on the drug. People with recent or unstable heart disease or stroke are not recommended to take the drug because of the potential heart risks. Vivus has also agreed to continue monitoring Qsymia users for side effects after the drug reaches market; in particular, it will conduct a long-term cardiovascular outcomes trial to assess the effect of Qsymia on major events like heart attack and stroke. The FDA’s approval of Qsymia, after such a long diet-drug drought and despite the potential safety problems that plague weight-loss pills, marks a willingness to make new solutions available.
Belviq, the first new prescription drug in years to help people lose weight, is expected to be available in four to six months. For the first time in 13 years, the Food and Drug Administration has approved a new drug to help people lose weight. "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." The drug was approved for obese people (those with a body mass index of 30 or more) and overweight people with a BMI of 27 or more who also have at least one weight-related health condition, such as high blood pressure, Type 2 diabetes or high cholesterol. 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. But the company submitted new data aimed at alleviating those concerns, and the same panel endorsed approval in May. The FDA hasn't approved a new weight-loss drug since Orlistat came on the market in 1999. The once-popular weight-loss drug Meridia was pulled from the market in 2010 because of concerns about heart attacks and strokes. The FDA had rejected Qnexa in 2010 because of concerns about heart problems and birth defects. 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.
However, when weight loss medications are combined with diet and exercise, as they should be, an added benefit may be seen. A low-fat diet and regular exercise are part of the weight-loss regimen that should be continued even if weight loss medicines are stopped. Update: The New Weight Loss Drugs Qsymia, Belviq and Contrave. In 2012, the FDA approved the first two new weight loss drugs in 13 years - Qsymia by Vivus Pharmaceuticals and Belviq by Arena Pharmaceuticals. Like Qsymia, the safety of taking Belviq with other weight loss drugs is not known. Alli should be used in conjunction with diet and regular exercise to promote weight loss. Drugs that are considered stimulant weight loss drugs include phentermine ( Adipex-P ), phendimetrazine ( Bontril SR ) and diethylpropion . These are controlled substances approved for short-term use in weight loss - usually only up to 12 weeks - because these drugs can lead to abuse and dependence with long-term use. As with other weight loss treatments, these drugs should be used in conjunction with diet and exercise to maintain weight loss. In contrast, Alli, Contrave, Belviq, and Qsymia are all approved for long-term use in weight loss. Are OTC Herbal Weight Loss Pills Safe and Effective?
Many doctors consider Qsymia, a new weight loss drug that was just approved by the Food and Drug Administration, the most effective of a new generation of anti-obesity medications. The drug, made by Vivus Inc., is intended for patients who have failed to lose weight in other ways. The pill was approved Tuesday, July 17, 2012 by the Food and Drug Administration for patients who are overweight or obese and also have at least one weight-related condition such as high blood pressure, diabetes or high cholesterol. WASHINGTON — A new weight-loss pill that many doctors consider the most effective of a new generation of anti-obesity drugs got the approval of the Food and Drug Administration on Tuesday. In testing, the drug made led patients to lose more weight than two other weight-loss pills recently review by the FDA. Patients taking Qsymia for a year lost 6.7 percent of their body weight in one study and 8.9 percent in another study, the FDA said. The drug is actually a combination of two older drugs long known to help with weight loss: phentermine and topirimate. Qsymia is the second weight-loss drug approved by the FDA in less than a month, following Arena Pharmaceutical’s pill Belviq in late June. Previously the agency had not approved a new drug for long-term weight loss since 1999. Vivus has to do studies of the heart effects of Qsymia, the FDA said.
The new medication can be used for obese or overweight adults to help them lose weight if they're struggling with at least one weight-related health problem such as hypertension or Type 2 diabetes. For the study, researchers conducted three trials that involved 4,800 obese or overweight participants with or without weight-related health conditions. All received healthy lifestyle counseling along with the drug, according to News Everyday . Findings revealed that non-diabetic participants on Saxenda lost an average of 4.5 percent in weight after one year, while 62 percent of those on the drug lost at least five percent of their body weight. In the placebo group, only 34 percent of the people lost about five percent of their body weight. For those who received Saxenda, close to 49 percent of them also lost at least five percent of their body weight. In the placebo group, another 16 percent achieved similar weight loss results. The window to the world of science news .
Food and Drug Administration approved the new weight loss pill Qsymia on Tuesday, adding to a very skimpy arsenal of drugs Americans can take to battle severe obesity - and adding a last-minute name change after two years of wrangling over whether to approve the drug. “Obesity threatens the overall wellbeing of patients and is a major public health concern,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. It’s the second obesity drug to win FDA approval this summer. Qsymia combines phentermine, a stimulant, with the anti-seizure drug topiramate. And the FDA worries about irresponsible doctors who dispense pills from their offices to just about all comers, whether they’re in the group that’s supposed to get the drug or not. Vivus, the company that makes the drug, has said it’s aware of this and has said it would restrict who can prescribe Qsymia and how. Michael Lauer, a cardiologist at the National Institutes of Health who was on the panel of experts that advised the FDA about the drug. Lauer and one other panelist voted against approval, but 20 panelists endorsed the drug in February. "As was the case for the diet drug lorcaserin (Belviq), approved last month despite concerns about heart valve damage, it was also reckless of the Food and Drug Administration to approve Qnexa. Reviewers say the amount of the drug phentermine in Qsymia is safer. Lauer said he would have liked to see more tests to specifically look for heart problems before the FDA approves the drug. Doctors tested the pill in more than 4,430 overweight and obese patients.
Obesity rates near 35 percent of the adult population, the Federal Food and Drug Administration (FDA) has approved a new prescription weight-loss pill for people who are obese or overweight called lorcacerin, and marketed under the name Belviq. The drug safely turns off the natural signals your body sends to your brain to remind you to eat enough food to maintain your current weight. And how much weight will I lose? How quickly will the weight come off? First, the drug is intended to be combined with a reduced-calorie diet and exercise, so it won't just whip you into shape unless you make some changes. "The one thing we have seen over and over again in studies that causes weight loss is increasing exercise and choosing healthier foods." In multiple studies totaling nearly 8,000 people who took Belviq, participants lost an average of between 3 and 3.7 percent of their body weight over the course of a year. The drug is only recommended for those who are obese (i.e., your body mass index is pushing 30 or greater), or overweight (i.e., you have a BMI of 27 or greater) and suffering from at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol. If you don't lose weight in the first three months, you might want to call it quits, as continued use is unlikely to cause weight loss, according to the FDA. Get the best eating and exercise plan for your body type and you can slim down in just six weeks. Potential side effects of Belviq include depression, migraines, and memory lapses—but no anal leakage, a much scoffed-about side effect of the only other FDA-approved prescription drug for long-term weight loss: Orlistat.
Who can take Belviq? How can I get Belviq? What is Belviq? Can anyone take Belviq? What are the Belviq guidlines? Can I take Belviq if I am nursing? What is the dosage for Belviq? What are the side effects with Belviq? Can I take Belviq with a heart condition? What is the retail price of Belviq? Can I take Belviq with other weight loss medications? Can a child take Belviq? What is the difference between Qsymia and Belviq? Are Qsymia and Belviq the same?
The agency on Tuesday approved Saxenda (liraglutide) for adults who are obese or for those who are overweight and have at least one weight-related health condition, such as high blood pressure, type 2 diabetes or high cholesterol. Patients taking the drug, made by Novo Nordisk, should still follow a low-calorie diet and exercise regularly, the FDA noted. Three clinical trials assessed the safety and effectiveness of the drug for weight loss. Of the people treated with the drug, 62 percent lost at least 5 percent of their body weight. The FDA added that patients should be examined to determine if Saxenda is working after 16 weeks of treatment. Those who do not lose at least 4 percent of their body weight by that time should stop taking the medication, the FDA said. Patients who experience a prolonged increase in their resting heart rate should stop taking Saxenda, the FDA added. Tumors of the thyroid gland were associated with Saxenda treatment in rodent studies. Patients who have been diagnosed with MTC or have a family history of the condition should not take Saxenda. Patients with a condition known as multiple endocrine neoplasia syndrome type 2, which increases the risk for MTC, should also not take Saxenda, the agency said. The FDA has also required that additional studies involving Saxenda investigate the safety and effectiveness of the drug in children, including how it could affect growth and development.
Regulators are greenlighting a new weight-loss drug called Contrave, the third in a string of approvals for anti-obesity treatments. The drug was developed by Orexigen Therapeutics Inc., based in La Jolla, California. The Food and Drug Administration said Thursday that it is approved for use by people who have a body mass index of 30 or higher, which is the level at which people are considered to be obese . D., director of the Division of Metabolism and Endocrinology Products in FDA's Center for Drug Evaluation and Research, in a press statement. The agency approved the drug for use in combination with a reduced-calorie diet and exercise. In testing, patients without diabetes who used the drug lost 4.1 percent more weight than those who took a placebo. The FDA recommends physicians who prescribe the drug evaluate their patients after 12 weeks to determine if it is working. The FDA refused to approve the drug in 2011, citing cardiovascular risks. In addition to Contrave, the FDA has approved Qsymia from Vivus Inc. Orexigen and Takeda plan to start selling the drug this fall.
A new, injectable weight-loss drug has been approved by the U. The agency on Tuesday approved Saxenda (liraglutide) for adults who are obese or for those who are overweight and have at least one weight-related health condition , such as high blood pressure, type 2 diabetes or high cholesterol. Patients taking the drug, made by Novo Nordisk, should still follow a low-calorie diet and exercise regularly, the FDA noted. Three clinical trials assessed the safety and effectiveness of the drug for weight loss. The trials involved roughly 4,800 obese and overweight people with and without other weight-related conditions. One clinical trial that involved patients without diabetes found that patients taking Saxenda had an average weight loss of 4.5 percent after one year. Of the people treated with the drug, 62 percent lost at least 5 percent of their body weight. The FDA added that patients should be examined to determine if Saxenda is working after 16 weeks of treatment. Those who do not lose at least 4 percent of their body weight by that time should stop taking the medication, the FDA said.
Weight-loss drug Belviq is now available by prescription for overweight or obese patients. A new drug, Belviq, is available to overweight and obese patients. The drug received FDA approval nearly a year ago. The FDA approved Belviq, an oral medication, in June 2012. 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." 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. In trials, 47% of patients without Type 2 diabetes lost at least 5% of their body weight on Belviq, according to the FDA. 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. The most common side effects of Belviq in nondiabetic patients included headache, dizziness and fatigue, according to the FDA.
And, even the search for a magic weight-loss pill is falling short, said Drs. The Federal Drug Administration has approved few drugs for long-term weight loss, and some are no longer marketed because of safety issues, the researchers said. In 2012, though, the FDA approved two drugs for long-term weight loss, lorcaserin hydrochloride (Belviq; Eisai Inc) and phentermine/topiramate (Qsymia; Vivus Inc). The trials for both drugs could not exclude important cardiovascular harms. The researchers said the FDA shared many of these concerns and the agency did not approve either drug on their initial applications. Nevertheless, the FDA approved the drugs and required the companies to conduct post-approval trials to assess the harms.
“When used as directed in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, Contrave provides another treatment option for chronic weight management for people who are obese or are overweight and have at least one weight-related health condition.” The effectiveness of Contrave was evaluated in multiple clinical trials that included approximately 4,500 obese and overweight patients with and without significant weight-related conditions treated for one year. In this trial, 42 percent of patients treated with Contrave lost at least 5 percent of their body weight compared with 17 percent of patients treated with placebo. In this trial, 36 percent of patients treated with Contrave lost at least 5 percent of their body weight compared with 18 percent of patients treated with placebo. If a patient has not lost at least 5 percent of baseline body weight, Contrave should be discontinued, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment. Because it contains bupropion, Contrave has a boxed warning to alert health care professionals and patients to the increased risk of suicidal thoughts and behaviors associated with antidepressant drugs. Contrave can cause seizures and must not be used in patients who have seizure disorders. Contrave should be discontinued and not restarted in patients who experience a seizure while being treated with Contrave. Contrave can also raise blood pressure and heart rate and must not be used in patients with uncontrolled high blood pressure. Blood pressure and pulse should be measured prior to starting the drug and should be monitored at regular intervals, particularly among patients with controlled high blood pressure prior to treatment. Patients undergoing an abrupt discontinuation of alcohol, benzodiazepines, barbiturates and antiepileptic drugs should not take Contrave. A cardiovascular outcomes trial to assess the cardiovascular risk associated with Contrave use; A clinical trial to evaluate the potential for interactions between Contrave and other drugs.
What Is Belviq, the New Weight Loss Drug? Belviq is a new weight loss drug that just became available by prescription this past week, one of only two new weight loss drugs approved by the FDA in the last 13 years. Pharmaceutical companies create new drugs, experiment with them, then market them for the effects that they produce. Reliable clinical studies have shown that people given the drug lost weight slightly more than people given a placebo , even without instruction in weight loss protocols. In almost all cases, the weight loss was slight, and the weight was regained after the trials. One would assume, based on the results of the clinical studies, that eating drive was reduced by the drug. We must establish new behavior where we eat less, to the degree that we lose weight and keep it off. Many people have used The Anderson Method to do just that, some saying it was easy. If you can do that without drugs, that will be the best solution. After all, you don't want to be taking these drugs for the rest of your life, even if they are safe. My advice, if you want to try a drug to help with weight control, is to find an expert in these drugs (psychiatrists or psychiatric nurses) and try one that is known to be safe.
- An FDA advisory committee has voted 13-7 that the modest weight-loss benefits of an investigational combination of naltrexone and bupropion - marketed under the brand name Contrave - outweigh the drug's blood pressure risk. The bupropion-naltrexone combo is the last in a trio of new weight-loss drugs that went before FDA panels this year, striving to be the latest treatment in the dwindling field of medications to fight obesity . The previous two drugs, phentermine/topiramate ( Qnexa ) and lorcaserin hydrochloride (Lorqess) were both rejected by the FDA after they fared poorly at advisory committee meetings. But Tuesday's advisory committee ended very differently than the previous two. Bupropion/naltrexone appeared to offer fewer side effects than the previous two drugs, although it also doesn't appear to work as well at helping obese patients lose weight. The Endocrine and Metabolic Drugs Advisory Committee reviewed results from Orexigen's four placebo-controlled, one-year, phase III clinical trials, which enrolled 3,200 obese patients with at least one comorbid condition, including diabetes and depression.
Food and Drug Administration's approval of two new weight-loss drugs within the past month - the first such medications in 13 years - won't be a panacea for America's obesity epidemic, health professionals say. And as the FDA's drug regulators reiterated when approving the two drugs, Qysmia and Belviq, no weight-loss medication should be used without also making lifestyle changes to facilitate weight loss . "The bottom line is there's no such thing as a magic pill and I hope that individuals do not think by taking this pill that it will ensure long-term weight loss," said Keri Gans, a registered dietitian in New York City. But Topamax also has side effects, including, possibly, numbness in the arms and legs, said Dr. And the drug can only be sold via specially certified drug stores. "There's the concern that too many people may have access to it when they simply need to make diet modifications and not look for some magic solutions." The drug may also cause problems with attention or memory, the FDA said. In patients with diabetes, side effects can include low blood sugar, headache, back pain, cough and fatigue, the FDA said. The cost of the drug is relatively modest, at least compared to other medications on the market, and may range between $100 and $200 for a month's supply, Aziz said. "The problem that all the drug companies are overlooking is the fact that obesity is really multi-factorial," Aziz said. S., registered dietitian, New York City, and author, The Small Change Diet; Michael Aziz, M. D., internist, Lenox Hill Hospital, New York City, and author, The Perfect 10 Diet.
Once the Drug Enforcement Administration clears it, the drug will be marketed in the U. Under the name Belviq. The Food and Drug Administration has approved marketing of the weight-loss drug lorcaserin, the first prescription anti-obesity medication to win the FDA's blessing since the agency approved orlistat in 1999. Once it is cleared by the Drug Enforcement Administration, the drug will be marketed in the United States under the commercial name Belviq. The FDA's approval came with a significant warning to consumers likely to flock to a medication that could help boost their weight loss: The safety and effectiveness of Belviq when used alongside other diet medications has not been established. In the 28 months since the makers of Belviq submitted the drug for FDA consideration, the agency also demanded the withdrawal of Meridia after studies showed it increased the risk of heart attack and stroke. That left only two FDA-approved weight-loss drugs on the market: orlistat and phentermine. One clinical trial found that two-thirds of patients on the drug lost 5% of their body weight, while one-third lost at least 10%, after one year of taking the drug as a supplement to diet and exercise. On Wednesday, Arena said it would conduct further studies to assess the safety and effectiveness of Belviq's long-term use and its safety for weight management in children. Qnexa, a combination of the diet drug phentermine and the anticonvulsant topiramate, sponsored by Vivus Inc. Another medication — Contrave, a combination of the anti-alcoholism drug naltrexone and the antidepressant bupropion — also awaits an FDA decision.
WASHINGTON—The Food and Drug Administration Wednesday approved a new weight-loss drug made by Arena Pharmaceuticals Inc., ARNA -5.00 % marking the first new drug treatment in more than a decade. The drug, lorcaserin, will be marketed under the brand name Belviq and distributed by Eisai Co. The approval of Belviq and other anti-obesity drugs has been held up for several years amid potential safety concerns that included heart-valve disease and in some cases cancer. The FDA said Belviq is meant to be used as part of an overall weight-management plan that includes a reduced calorie diet and exercise. This raises the risk of developing heart disease, diabetes and cancer. The drug would be the first commercial product for the San Diego company, which was founded in 1997 and has been unprofitable. The drug has to go through a four-to-six month process at the Drug Enforcement Administration for a scheduling classification used for drugs that have a likelihood or potential of being abused. Once that process is over, Eisai will announce pricing and when the drug will be available. Analysts have been cautious in their estimates for Belviq's annual sales, and they generally expect Qnexa, if approved, to grab a larger share of the market. However, the potential market size is worth billions of dollars, and Belviq is expected to be used alone and in combination with drugs like Qnexa, assuming they are approved. The FDA said Belviq should be stopped in patients who fail to lose 5% of their body weight after 12 weeks of treatment because they are unlikely to "achieve clinically meaningful weight loss." The drug was approved to treat people who are obese, which is defined as a body mass index of 30 or higher, and people who are overweight, with a BMI of 27 or higher, and who also have at least one weight-related problem like high-blood pressure, high cholesterol or diabetes. BMI is a measure of body fat that uses height and weight in the calculation.
June 27, 2012 - For the first time in more than a decade, the FDA has approved a new drug to help people lose weight . Today, Arena Pharmaceuticals' Belviq (lorcaserin hydrochloride) became the first prescription weight loss drug approved by federal regulators in 13 years. The FDA approved Belviq as an addition to a reduced-calorie diet and exercise , for use in chronic weight control .
New Weight Loss Drug Approved By FDA: Compare Diet Pills, Diets, And Supplements. Just in time for those New Year’s weight loss resolutions, the Food and Drug Administration (FDA) has approved a new weight loss drug . The FDA emphasized that patients who use the weight loss drug should diet and exercise for optimal results. However, the FDA recommends that physicians evaluate patients after 16 weeks on Saxenda. If they have not lost four percent of their body weight, they should end the treatment. And, although appetite reduction is considered one of the benefits of Saxenda, the loss of appetite is listed among the side effects. For those who want to jump-start weight loss and aren’t in the category for whom the prescription medication is designed, new studies have shown that short-term rapid weight loss diets can be effective. However, the former President initially credited a vegan diet for helping him heal from his heart attack and lose weight, as he discusses below. After years of few prescription options for weight loss , the FDA has now approved four drugs since 2012, reported Web MD. The FDA recommends halting treatment if patients have not lost five percent of their weight after 12 weeks. The FDA suggests ending the prescription if you have not lost five percent of your weight within 12 weeks. The FDA suggests that if patients have not lost three percent of their weight after 12 weeks, physicians increase the dosage. However, more than 90 percent reported that the supplements did not work.
Louis Aronne, director of the weight loss program at Weill-Cornell Medical College. Vivus Inc.'s Qnexa is thought to be the most promising of the drugs, achieving the most weight loss. Arena's studies showed that patients taking Belviq, known generically as lorcaserin, had modest weight loss. By comparison, average weight loss with Qnexa is 11 percent, with more than 83 percent of patients losing 5 percent of their weight or more. The FDA said patients should stop taking Belviq after three months if they fail to lose 5 percent of their body weight. Patients are unlikely to see any significant weight loss by staying with the drug. Side effects with the drug include depression, migraine and memory lapses. Experts say the challenge of weight loss drug development lies in safely turning off one of the body's fundamental directives: to eat enough food to maintain its current weight. Belviq is the first new prescription drug approved to treat obesity since Xenical's approval 13 years ago.