Fda drug for weight loss


FDA - Approved Weight Loss Treatments


Patients recharge the device at home, and physicians tailor the strength of the electric signals to a patient's needs. In clinical trials, two groups of obese patients received the device, but researchers only turned it on in one group. The FDA also approved Vyvanse as the first and only drug to treat binge-eating disorder—a psychological diagnosis characterized by frequent episodes of overeating and associated feelings of shame. Binge-eating is the most common eating disorder in the United States, and two-thirds of binge-eaters are obese. In at least one trial , a 50 mg and a 70 mg dose of Vyvanse significantly reduced the number of weekly binge-eating episodes. According to a 2013 study , an average dose of Vyvvanse leads to weight loss and an improved BMI for patients with bipolar disorder. Not all the news is sunny with Vyvanse, warn experts. "Substance abuse is a concern and is often linked with binge-eating disorder," says Guarda.


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FDA warns of banned drugs and Viagra in weight loss


FDA warns of banned drugs and Viagra in weight loss supplements. The FDA is flagging five more weight loss supplements because they contain pharmaceuticals, including the banned drug Meridia and generic Viagra. The supplements also contain antidepressants and other drugs that have been shown to be carcinogenic. CLEVELAND, Ohio - The Food and Drug Administration is again warning consumers of dangerous weight loss supplements that contain pharmaceutical drugs, including the weight loss drug Meridia, which was pulled from the market in 2010 for safety reasons. Four of the five weight loss supplements - Black Mamba Hyperrush , Diablos ECA Fire Caps ,  Natural Max Slimming and Lean Body Extreme - all contain sibutramine, the generic form of Meridia, and other drugs, including phenolphthalein, a laxative ingredient the FDA banned in the 1990's because it is potentially carcinogenic. Consumers who bought three of the five weight loss pills (Diablos ECA, Natural Max Slimming and Lean Body Extreme) also got another surprise ingredient, according to the FDA: generic Viagra. The FDA notes that there is a growing trend of dietary supplements and weight loss products containing unadvertised drugs and chemicals.


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Anti - obesity medication - Wikipedia, the free encyclopedia


Orlistat (Xenical) the most commonly used medication to treat obesity and sibutramine (Meridia) a medication that was recently withdrawn due to cardiovascular side effects. [1] 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. [13] 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. [44] 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.


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Fda Approved Weight Loss Drug


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Prescription Weight Loss / Diet Pills : What Are the Options


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.


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New weight - loss drug available


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.


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Newly Approved Weight Loss Drugs - Can They Help You


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?


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FDA approves weight - loss drug, with a new name


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.


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FDA Approves New Weight - Loss Drug


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.


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Weight - loss drug Contrave wins FDA approval on second try


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.


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Weight Loss Drug Doesn't Deliver On Claims : Study


Early research about Contrave suggested the drug was good for heart health, a message that made its way to the public. In fact, there was almost no significant difference in heart events among the people taking the drug and those taking a placebo. The FDA, the drug maker and the scientists doing the trial must agree on a pre-specified threshold of safety that the drug has to meet. The FDA also requires that trials for approval be blinded, so that researchers and the people in the studies are not aware of whether they are taking the drug or a placebo. In Contrave’s case, the early finding that the drug was linked to a 41% lower risk of heart events was shared with more than 100 people. And because the results meant it met that agreed-upon threshold for safety, the FDA approved the drug. It also requested an entirely new study to continue evaluating the drug’s heart safety and shut down the existing trial. The only thing for certain is that it doesn’t double the risk of heart events compared to people taking placebo. Orexigen is now funding a new trial that will deliver a more definitive answer on the heart safety of its drug, which Nissen will lead.


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FDA approves new diet drug


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.


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FDA Approves First New Weight - Loss Drug In More Than A


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.


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FDA approves weight - management drug Qsymia


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.


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FDA Approves Novel Weight Loss Device Inside Health News


Called the Maestro Rechargeable System, it’s only the third device approved to treat obesity and the first approved since 2007. The other two devices are bands that physically limit the size of the stomach. The series, Web MD’s Future of Health with Robin Roberts, will feature five promising health and medical advances and will be published early this year. The device is approved for people 18 and older who have a body mass index (BMI) of 35 to 45 and at least one other obesity-related condition, like type 2 diabetes. In the original plan for the study, researchers said the device would be a success if it helped people lose at least 10% of their body weight, on average. When an FDA advisory committee backed the device, it noted that people who lost weight with it were able to sustain their losses over time. It also took into account the results of a patient survey, sponsored by the FDA, which showed that people struggling with obesity would be willing to accept risks associated with the device for the amount of weight loss they could expect. The opinions expressed in Web MD Second Opinion are solely those of the User, who may or may not have medical or scientific training. These opinions do not represent the opinions of Web MD. These opinions do not represent the opinions of Web MD Second Opinion are not reviewed by a Web MD physician or any member of the Web MD editorial staff for accuracy, balance, objectivity, or any other reason except for compliance with our Terms and Conditions. Some of these opinions may contain information about treatments or uses of drug products that have not been approved by the U.


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New weight - loss drug Saxenda wins FDA approval


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.


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Fda Approved Weight Loss Drug


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FDA approves a device for weight loss - LA Times


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.


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Contrave, Newest Weight Loss Option : FAQ


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.


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FDA Approves New Weight - Loss Drug


Saxenda cleared for use by adults who are obese or overweight and have at least one weight-related condition. 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. 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. The most common side effects associated with Saxenda included nausea, diarrhea, constipation, vomiting, low blood sugar and loss of appetite. 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.


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FDA Approves Weight - Loss Drug, Saxenda : Health


(Photo : Pixabay/ mojzagrebinfo) Out of the participants who were on the drug, 62 percent had lost at least five percent of their body weight. Out of the participants who were on the drug, 62 percent had lost at least five percent of their body weight. In the placebo group, only 34 percent of the people lost at least five percent of their body weight. In the other trial, researchers found that type 2 diabetics had an average weight loss of nearly four percent after one year. Out of the people who received Saxenda, 49 percent of them lost at least five percent of their body weight. In the placebo group, only 16 percent achieved similar weight loss results. Patients who do not lose at least four percent of their body weight should not continue taking the medication.


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FDA Approves Contrave Weight Control Drug Video - ABC News


Jennifer Ashton explains how the new drug works and the possible health risks. Coming up in the next {countdown} {countdownlbl} This represents a whole new target in the medication attack on chronic and morbid obesity meaning it works in the brain to fight those central signals that drive hunger, reward, impulse and send those signals of ha satiety. Who is this not for? This is not for the person who wants to lose five pounds for the wedding next weekend. This is for adults with a bmi of 27 or 30 or above who have failed attempts at aggressive weight loss with diet and exercise alone. It did take the fda a long time to approve this drug. They come with some serious side effects and when you're talking about this drug, the side effects are no joke, a risk of suicidal thoughts, seizure, not for someone with a she is sure disorder and common symptom, nausea, dizziness, insomnia. Some are metabolic so when we attack the obesity problem in some cases we have to attack from all fronts, diet, good nutrition, exercise, medication and sometimes surgery. This transcript has been automatically generated and may not be 100% accurate.


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FDA approves a third new weight - loss pill - USA TODAY


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.


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Weight loss drug Saxenda wins FDA approval - CBS News


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.


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FDA approves new weight loss drug Contrave - CBS News


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.


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FDA Approves Diet Pill Belviq


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 .


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Qsymia


Your weight loss may vary depending on your BMI, diet, activity, dose of Qsymia, and other factors.1,2. Qsymia is an FDA-approved prescription weight-loss medicine that can work with diet and activity to help you lose 20 pounds or more and lose 4 inches or more off your waist. See your doctor now and ask for Qsymia. If you take Qsymia during pregnancy, your baby has a higher risk for birth defects called cleft lip and cleft palate. If you become pregnant while taking Qsymia, stop taking Qsymia immediately, and tell your healthcare provider right away. Your healthcare provider should check your heart rate while you take Qsymia. Your healthcare provider should do a blood test to measure the level of acid in your blood before and during your treatment with Qsymia. You should check your blood sugar before you start taking Qsymia and while you take Qsymia. If you are taking medicines for your blood pressure, your doctor may need to adjust these medicines while taking Qsymia. Your healthcare provider will tell you how to stop taking Qsymia slowly. These are not all of the possible side effects of Qsymia.


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FDA delays decision on latest weight loss pill - USA TODAY


FDA delays decision on latest weight loss pill. Consumers awaiting the latest weight loss pill will have to wait at least another three months. The FDA has delayed a decision that was expected today on the prescription medication Contrave. FDA delays decision on latest weight loss pill Consumers awaiting the latest weight loss pill will have to wait at least another three months. FDA is delaying a decision on the latest prescription weight loss pill, a drugmaker announced Wednesday. Consumers awaiting the latest weight loss pill will have to wait at least three more months. The Food and Drug Administration has delayed a decision that was expected Wednesday on the prescription medication Contrave, drugmaker Orexigen Therapeutics Inc. If approved in September, the drug will be the third new prescription weight loss aid in about two years, joining Qsymia, from Vivus Inc. The company already has submitted interim cardiovascular data from an ongoing study of 8,900 patients — which the FDA requested after it rejected Contrave in 2011. Reasons include costs, low levels of insurance coverage and lingering concerns about the safety of any weight loss drug. Ryan, who has consulted for companies including Vivus, Eisai and Takeda, says the delay from FDA on the latest contender "is not a negative signal, it's a sign that officials at the FDA are taking the review seriously — as they should."


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FDA approves a third new weight - loss pill - Detroit Free Press


To find out more about Facebook commenting please read the Conversation Guidelines and FAQs. 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. So far, the other new pills have not been big sellers – considering that more than a third of U. 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.


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Fda Weight Loss Drug Guidelines


Fda Weight Loss Drug Guidelines. You could have various normal ways on the market to choose from, without a Weight drug fda loss guidelines doubt there can be one which will in shape your unique your life style. Some of the vital areas of the body Guidelines loss fda weight drug that require interest are waist line, arms, legs, buttocks, tummy area, fretboard and chin. Going on a should always be a critical component Guidelines loss weight drug fda of the suffer a Guidelines fda weight drug loss loss of weight quickly dietplan. Water clears out bad toxins from your body Drug weight loss guidelines fda system, flushes out the kidneys, grows the metabolism producing your physique lose fat more quickly. Your roly-poly physical structure will make the viewers Guidelines fda weight loss drug burst into laughter. Just consume less, but more times in the daytime, as your human body demands that to melt away seeing that petrol, which usually will increase your motabolism and give the strength you have to do these Fda weight loss drug guidelines terrifying physical Fda weight loss drug guidelines exercises. This will help to you stay away from snacks and in addition help you decrease the Fda weight loss drug guidelines selection of meals that you Fda weight loss drug guidelines take in. That Fda weight loss drug guidelines will be the greatest rationale but to get your physique shifting. Today to lose Fda weight loss drug guidelines a lot of weight in a month Fda weight loss drug guidelines does not imply that you have to starve yourself and put yourself through serious physical exercises. Foods which might be low in calories is usually a superb way to lose the Fda weight loss drug guidelines little one weight. It is just a proven fact that the majority of people who will be dealing Fda weight loss drug guidelines with a weight issue tend to have a lower self-confidence than someone who can be healthier. For most Fda weight loss drug guidelines people, Fda weight loss drug guidelines it does not last long. © Fda Weight Loss Drug Guidelines - Here are a few 3 main reasons why Fda weight loss drug guidelines it's hard to lose excess weight whenever you get older.


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New Weight Loss Drug Approved By FDA : Compare Diet Pills


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.


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FDA approves weight - management drug Contrave


“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.


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FDA approves weight loss drug Qsymia, but we say skip it


The Food and Drug Administration Tuesday approved Qsymia, a combination of the stimulant phentermine and the anti-seizure drug topiramate extended-release, to help obese and overweight people lose weight. According to the evidence submitted to the FDA, Qsymia appears to help people drop a few pounds. But that small benefit is probably not worth the risks of birth defects, heart attacks, and strokes. In fact, two years ago the FDA rejected the drug, then called Qnexa, due to these concerns, and it is not clear why the FDA reversed course this time, since those side effects are still an issue. The drug also carries a warning that it can increase heart rate and should not be used by people who have heart disease or have suffered a stroke. Due to the heart concern, Vivus, the manufacturer of Qsymia, is required to conduct a study to determine whether the drug poses a risk of major cardiovascular problems, including heart attack and stroke. Qsymia will only be available through specially certified pharmacies under a Risk Evaluation and Mitigation Strategy, or REMS, which is intended to inform doctors and patients about the possibility of birth defects. "The very idea that a post marketing risk evaluation strategy was a condition required by the FDA for approval of this combination drug product seems like putting the cart ahead of the horse," says Marvin Lipman, M. Qsymia contains several additional warnings, including that it can increase the risk of glaucoma, kidney stones, mood problems such as anxiety and depression, and suicidal behavior or thinking about suicide (ideation). "This drug should only be used in the confines of a research trial in which consumers have been fully informed of its risks and benefits and, someone is responsible for the complications that occur. And even if they do help you to shed a few pounds, the side effects can be troublesome and even dangerous.


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FDA Approves Diet Drug Qsymia - ABC News


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.


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FDA Approves New Weight - Loss Drug Contrave - NBC News


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.


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Orlistat - FDA Approved Weight Loss Drug


You are here: Home / FDA Approved Drugs for Weight Loss / Orlistat. Orlistat. Orlistat has the longest track record as a FDA approved treatment for obesity. Orlistat is also known as Alli, the FDA approved, less potent over the counter version of orlistat. And Orlistat is also known as Xenical. In the course of a year, clinical trials that received orlistat in addition to diet and lifestyle changes report additional 4.4 – 6.6 lbs. Orlistat can cause small but significant decreases in fat-soluble vitamins such as vitamin A, D, E, and K.


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