Weight Loss Pill Just Approved By Fda


Lorcacerin : New FDA - Approved Weight


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.


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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 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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FDA approves weight - loss drug, with a new name


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. 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 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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New weight loss pill approved by FDA - Dr. Z's Medical Report


What this drug does is to prevent the body from absorbing part of the fat in your diet. They can get away with this because the GI effects are due to the way the drug works – less fat in, more fat out). So what does the FDA and GSK/Roche recommend you do to help avoid GI “treatment effects?” Eat a low-fat diet! Because the more fat you eat, the more you’ll “discharge.” So now I take a pill (by the way it’s three times a day – once with each meal), to help me lose weight that won’t work unless I eat a low-calorie, low-fat diet and exercise AND will cause my bowels to lose control if I don’t eat a low-fat diet. This is sort of like the anti-alcoholism drug Antabuse, which, if you do drink while taking it makes you violently sick. Only in this case, you have to take the drug to force you to eat a low-fat diet or face the oily consequences. And did I mention that because you don’t absorb as much fat, you will also not be able to absorb the fat-soluble vitamins A, D, E and K? But wait, I’ve got an idea: Why not skip the drug, avoid its cost, avoid its awful “treatment effects,” avoid worrying about taking it three times a day, avoid taking a multi-vitamin at bedtime, and get real about what you eat and how active you are! I repeat the following over and over in this blog: EAT A LITTLE LESS AND EXERCISE A LITTLE MORE. I’m hopeful you’ve also realized that if you do start taking this drug, and don’t make significant diet and lifestyle changes, that the moment you stop the drug the weight will come right back.


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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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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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Weight - loss pill Belviq gets the OK from the FDA


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.


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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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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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Obesity pill Belviq : FDA approves first long


Obesity pill Belviq: FDA approves first long-term prescription weight loss drug in 13 years. The Food and Drug Administration has approved the first new prescription drug for long-term weight loss into the U. Long wait: The anti-obesity pill Belviq is the first new prescription drug approved by the Food and Drug Administration in over a decade. Obesity rates nearing 35 per cent of the adult population, many doctors have called on the FDA to approve new weight loss treatments. The cocktail of phentermine and fenfluramine was a popular weight loss combination prescribed by doctors, though it was never approved by FDA. Obesity rates are near 35 per cent of the adult population stressing doctors to encourage the FDA to approve new weight loss treatments. Effects: The FDA said patients should stop taking Belviq after three months if they fail to lose 5 per cent of their body weight as positive results are then not expected. 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.


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New Diet Drugs Hit the Market - ABC News


With more than 36 percent of American adults now classified as obese according to the Centers for Disease Control and Prevention, and the numbers still climbing, doctors are clamoring for more pharmaceuticals to treat their patients. But even as doctors have begun scribbling prescriptions for these new weight loss medications, many dieters remember the long and checkered past of diet drugs in this country. Some drugs that were originally viewed as rock stars for weight loss and appetite control were ultimately pulled off the market after it was found they posed serious health risks. "Once people stopped losing weight they would take more and more of the pills, and this left some feeling racy and agitated with a rapid pulse and high blood pressure," said Dr. By the 1970s, the FDA limited its use for weight loss to short-term treatment only. Riding the wave of the supplement's popularity a similar drug named dexfenfluramine and marketed as Redux was quickly approved by the FDA in 1996. Approved in 1997, the drug was found during clinical trials to increase heart rate and blood pressure. The drug's risks proved not to be worth the benefits: Studies found a 16 percent increase of major cardiac events in patients taking Meridia compared with those who weren't taking the drug, with a negligible difference in weight loss. Done often enough, the drug is not as effective and weight loss is minimal. Belviq is approved for the obese and those who are overweight and have other serious health risks. In clinical trials, the average person lost 3 percent to 3.7 percent of his weight after taking Belviq for a year compared to those taking a placebo. The FDA said patients should stop taking Belviq if they fail to lose 5 percent of their body weight after three months of use. Patients are unlikely to see any significant weight loss by staying on the drug, the agency said. About half of the 4,430 overweight and obese patients in the Qsymia studies on the recommended dosage lost an average of 10 percent of their weight in the first year of taking the drug. We are talking about taking a pill to fix what's busted - the circuitry of the brain that misreads the signals of appetite, fat storage and other factors.


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Diet Pill Just Approved By Fda


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FDA approves another weight loss pill


To find out more about Facebook commenting please read the Conversation Guidelines and FAQs. (USA TODAY) - For the third time in about two years, the Food and Drug Administration has approved a new weight-loss pill. It joins some older drugs and two newer pills, Qsymia and Belviq, as options to help adults battle their bulges. All of the new drugs work by decreasing appetite and all have some side effects and drawbacks, though they differ. Like its competitors, Contrave is approved for people who are obese or who are overweight and also have weight-related health problems, such as diabetes. 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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Highly anticipated weight - loss pill wins approval


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.


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FDA - Approved Fat - Fighting Pill Hits Market With Big Promises


The FDA has approved a new diet pill called Contrave, which it believes can be extremely effective if taken the correct way. According to the FDA, it is only effective when used in combination with a healthy lifestyle—including a nutritious low-calorie diet and exercise—and is only to be prescribed as part of an overall weight-loss plan. D., says the new medicine holds great promise for people who combine its use with regular exercise and a reduced-calorie diet. Notes Contrave was first recommended for approval by an FDA advisory panel in 2011, but the agency rejected it at the time. Gulfo argues the FDA should have approved the drug years ago, when it had all the evidence it needed that the medication is not only effective, but also safe. The FDA approved Contrave for people unable to lose weight through diet and exercise alone who aren't ready for weight-loss surgery. And the FDA has approved two other weight-loss drugs in just the past two years—Qsymia and Belviq. It can also increase blood pressure, and should not be used in people with uncontrolled high blood pressure, according to the FDA. In addition, Contrave increases the risk for seizures, and should not be used by those with seizure disorders. "[But] for the right patient who's exercising and watching their diet, it's great."


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Highly anticipated weight - loss pill wins approval - Yahoo News


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 (AP) — 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. The pill, called Qsymia, was approved 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. The drug's maker, Vivus Inc., said it plans to bring the drug to market in the fourth quarter of this year. 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.


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Qsymia : FDA Approves Another New Diet Drug


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.


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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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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 First New Weight - Loss Pill In Decade


WASHINGTON — The Food and Drug Administration has approved Arena Pharmaceutical’s anti-obesity pill Belviq, the first new prescription drug for long-term weight loss to enter the U. Despite only achieving modest weight loss in clinical studies, the drug appeared safe enough to win the FDA’s endorsement, amid calls from doctors for new weight-loss treatments. The drug should be used in combination with a healthy diet and exercise. The FDA denied approval for Arena’s drug in 2010 after scientists raised concerns about tumors that developed in animals studied with the drug. The company resubmitted the drug with additional data earlier this year, and the FDA said there was little risk of tumors in humans. Obesity rates nearing 35 percent of the adult population, many doctors have called on the FDA to approve new weight loss treatments. But a long line of prescription weight loss offerings have been associated with safety problems, most notably the fen-phen combination, which was linked to heart valve damage in 1997. The cocktail of phentermine and fenfluramine was a popular weight loss combination prescribed by doctors, though it was never approved by the FDA. Shares of Orexigen Therapeutics Inc., the third drugmaker with an obesity pill before the FDA, rose 20 percent to close at $4.92. 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. Belviq is the first new prescription drug approved to treat obesity since Xenical’s approval 13 years ago.


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2015 : Finding The Best New - Weight Loss Pills Work


Recent history is full of examples of various weight loss drugs approved by the FDA but were later found to be dangerous. In the 1990s, a combination of two appetite suppressants, fenfluramine and phentermine, were found to cause weight loss amounting to 16% of the body weight. What’s more, it was also discovered that Meridia did not cause weight loss. In studies, it was shown that only half showed weight loss with this drug. So if even the best FDA approved diet pills aren’t exactly your best bets to supplement your weight loss efforts, what should you take instead? The solution is to take natural weight loss supplements instead. This is unroasted coffee beans, and the extract from these beans is among the most renowned among all the natural weight loss supplements available. Food cravings, as you well know, are one of the major road blocks to weight loss. Garcinia Cambogia also helps you feel a lot fuller, and that helps you suppress your appetite so you don’t let food cravings sabotage your weight loss efforts. Forskolin is also another weight loss supplement that can work for you. This is an extract from a plant in the mint family, and it has been found to offer weight loss benefits.


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FDA Approves Orexigen Diet Pill Contrave - Business Insider


The Food and Drug Administration has approved Contrave "as treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity," the agency announced on Wednesday. "Drugs are not the answer to epidemic obesity, but they can be of help in select cases," David L. More than  a third of Americans  are obese, and while pharmaceutical companies have been racing to find a treatment with blockbuster potential, Katz suggests that prescribing an anti-obesity drug should not become the standard treatment. First, the drug is meant to be used alongside, not in place of, a reduced-calorie diet and exercise. The Renasci researchers writing in the International Journal of Obesity noted that based on trial results so far, Contrave "would not satisfy the criterion" of the FDA's European counterpart "for a clinically effective antiobesity drug." "But the potential toxicity of this drug is considerable, and the weight will likely be regained if the drug is ever stopped." What are the side effects? What are the major drugs competing with Contrave? "The argument for approving weight loss drugs is not that [they are] really very good, but rather that 'something is better than nothing,'" he said. Contrave is not a solution to the obesity epidemic, and it's certainly not the best plan of action for most people struggling with excess weight. "As the majority of patients are unlikely to achieve the high degree of weight loss that they are seeking, it is questionable how willing they will be to pay for Contrave," the Renasi scientists note in the International Journal of Obesity .


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Prescription weight - loss drugs : Can they help you


Drug treatments for obesity: Orlistat, sibutramine and remonabant. Xenical (prescribing information). Belviq (prescribing information). FDA approves weight-management drug Qsymia. Qsymia (prescribing information). FDA approves Qsymia, a weight-loss drug. Didrex (prescribing information). Suprenza (prescribing information). Tenuate (prescribing information). Bontril (prescribing information). Contrave (prescribing information). FDA approves weight-management drug Contrave. FDA approves weight-management drug Saxenda. Saxenda (prescribing information).


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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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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 highly anticipated weight - loss pill


WASHINGTON (AP) — The Food and Drug Administration on Tuesday approved a new weight loss drug from Vivus Inc. 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. That was more than two other weight loss pill recently reviewed by the FDA. The drug is actually a combination of two older drugs that have long been known to help with weight loss: phentermine and topirimate. Phentermine is a stimulant that suppresses the appetite, and has long been used for short-term weight loss. 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. Obesity rates nearing 35 percent of the adult population, many doctors have called on the FDA to approve new weight loss treatments. The cocktail of phentermine and fenfluramine was a popular weight loss combination prescribed by doctors, though it was never approved by the FDA. Vivus has to do studies of the heart effects of Qsymia, the FDA said.


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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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The FDA Just Approved A New Diet Pill With Expected Sales


The Food and Drug Administration has approved Contrave "as treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity," the agency announced on Wednesday. "Drugs are not the answer to epidemic obesity, but they can be of help in select cases," David L. More than  a third of Americans  are obese, and while pharmaceutical companies have been racing to find a treatment with blockbuster potential, Katz suggests that prescribing an anti-obesity drug should not become the standard treatment. First, the drug is meant to be used alongside, not in place of, a reduced-calorie diet and exercise. The Renasci researchers writing in the International Journal of Obesity noted that based on trial results so far, Contrave "would not satisfy the criterion" of the FDA's European counterpart "for a clinically effective antiobesity drug." "But the potential toxicity of this drug is considerable, and the weight will likely be regained if the drug is ever stopped." What are the major drugs competing with Contrave? "The argument for approving weight loss drugs is not that [they are] really very good, but rather that 'something is better than nothing,'" he said. Contrave is not a solution to the obesity epidemic, and it's certainly not the best plan of action for most people struggling with excess weight. "As the majority of patients are unlikely to achieve the high degree of weight loss that they are seeking, it is questionable how willing they will be to pay for Contrave," the Renasi scientists note in the International Journal of Obesity .


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FDA approves weight - loss drug Contrave - Harvard Health Blog


FDA approves weight-loss drug Contrave. For the third time in two years, the FDA has approved a drug to help people lose weight. The new drug, Contrave, combines two generic drugs, naltrexone and bupropion. Contrave joins Belviq (lorcaserin) which the FDA approved in June 2012 , and Qsymia, which got the green light a month later . Does Contrave work? The FDA approved Contrave based on the results of several clinical trials that included 4,500 overweight and obese men and women. In one trial of people without diabetes, 42% of those who took Contrave lost at least 5% of their body weight, compared with 17% of those who took a placebo. In a trial of people with diabetes, 36% of those taking Contrave lost at least 5% of their body weight, compared with 18 % of those taking a placebo. If Contrave does not work after 12 weeks, the FDA says its use should be stopped. Why should the combination of a drug for addiction and one for depression help with weight loss?


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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 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 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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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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Weight Loss Pills - 2016's Best Weight Loss Pills


The road to successful weight loss can be lonely – with the thousands and thousands of products in the market, it can be difficult to find that one solution that works for you. This is where we come in – Weight Loss Pills is your #1 resource for the top rated and the best selling weight loss supplements in the market today. We offer comprehensive reviews and ratings for the most talked about and most successful weight loss pills in the industry, so you won't have to go down that road alone. With unbiased and objective reviews of the best of the best, expect to finally find the weight loss pill that matches your needs. You'll get all the tools you need to finally reach your weight loss goals. Giving you rapid belly melt, Nature's Pure Forskolin is the answer to healthy and natural weight loss. We, at Weight Loss Pills, are a team of professional researchers that gather the most extensive reviews and information on the top rated supplements currently making a buzz in the market today. Just like you, we want to find the answers to what the best weight loss pills are and why they work. Let us make the job of finding genuine weight loss pills for you. In the weight loss industry today, manufacturers don't have to seek the approval of the FDA to be able to put their products in the market - which makes it even more difficult for you to really find that authentic weight loss pill that will meet your needs. Let us help you find the weight loss pill that matches your needs, the bestselling products that have satisfied millions, and help you compare one product from the other.


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About - alli Weight Loss Pill


For every 2 pounds you lose through diet and exercise, alli® can help you lose 1 more. Just stick with a reduced-calorie, low-fat diet – and alli® can help maximize your efforts. Alli® prevents about 25% of the fat you eat from getting absorbed into your body. Alli® is the only FDA-approved over-the-counter weight loss aid around. FIND OUT IF alli® IS RIGHT FOR YOU  Just use this BMI (Body Mass Index) tool to find out if you could benefit from taking alli® to reach your weight loss goals.


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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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Qsymia, Prescription Weight - Loss Pill, Approved By FDA


Qsymia, Prescription Weight-Loss Pill, Approved By FDA. Qsymia, a new prescription diet drug , was approved by the FDA Tuesday. Qsymia is the second prescription weight-loss pill to be approved this year. The first, Belviq , was approved on June 27.


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FDA Approves New Appetite Pacemaker Device - NBC News


Entero Medics VBLOC® vagal blocking therapy is delivered via a pacemaker like device called the Maestro® System. Federal health officials approved a new obesity device Wednesday that controls appetite with electrical pulses. It's the first new obesity device to be approved by the Food and Drug Administration in more than seven years. The surgically implanted device, called Maestro, is designed to interrupt hunger signals from the brain to the stomach, and it's manually controlled. "The Maestro Rechargeable System, the first FDA-approved obesity device since 2007, is approved to treat patients aged 18 and older who have not been able to lose weight with a weight loss program, and who have a body mass index of 35 to 45 with at least one other obesity-related condition, such as type 2 diabetes," the FDA said in a statement. The device is implanted under the skin of the abdomen, with attachments placed just where the esophagus meets the stomach. It's designed to interfere with the abdominal branch of the vagus nerve, a central nerve that controls the heart and digestive tract. The company that makes the device, Entero Medics Inc., designed it to interfere with hunger signals using a technology called VBLOC. "By blocking signals along the nerves that connect the brain and stomach, VBLOC reduces feelings of hunger and promotes earlier feelings of fullness, which can help people with obesity reduce the number of calories consumed and promote safe, healthy and durable weight loss," said Dr. It should work in theory, says Fernstrom, but in fact it is not entirely clear if the device is interfering with hunger or acting in some other way. "Although it is known that the electric stimulation blocks nerve activity between the brain and the stomach, the specific mechanisms for weight loss due to use of the device are unknown," the FDA said. The FDA wanted the device to be 10 percent better, on average, than a placebo but has approved it anyway. There's an appetite pacemaker, as well, that's approved in Europe but not the U.


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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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