What Is The New Weight Loss Drug Approved By The Fda


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. more...



New Obesity Drug, Contrave, Gets FDA Approval

11, 2014 (Health Day News) — The U. Food and Drug Administration’s approval of a new weight-loss drug on Wednesday marks the third time the agency has given its blessing to a new diet medication since 2012. Called Contrave, the medicine is a combination of two approved drugs: naltrexone, which treats alcohol and drug addiction, and bupropion, which treats depression and seasonal affective disorder and is used to help smokers quit. The agency said in a news release that Contrave can be used by obese adults and by overweight adults who have at least one other weight-related condition or illness, such as high blood pressure or type 2 diabetes. Centers for Disease Control and Prevention, more than one-third of adults in the United States are obese, the FDA said in its news release. Contrave was developed for people unable to lose weight through diet and exercise alone who aren’t ready for weight-loss surgery, according to the newspaper. Because Contrave contains bupropion, the label will include a boxed warning about the increased risk of suicidal thoughts and behaviors associated with antidepressants. Contrave can also increase blood pressure, and should not be used in people with uncontrolled high blood pressure, according to the FDA. more...



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. more...



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. more...



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. more...



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. more...



Qnexa weight loss - NRX HEALTH

Qnexa / Qsymia is not available for prescription now but if approved by the FDA, you could be prescribed and be able to buy Qnexa soon. Read on for the FDA Approval status on the anti-obesity prescription drug Qnexa / Qsymia on Tuesday, July 17th, 2012. So they are looking for an easier weight loss solution that isn’t quite as demanding on their time and their energy so the popularity and hype surrounding this newly approved prescription weight loss pills comes as no surprise. There is no need for people to keep waiting for the prescription drug Qnexa. There is a study that reveals the similarities of Qnexa / Qsymia to other prescription weight loss pills and that they can increase the chances of heart attacks and strokes (from heart palpitations). It is the first prescription weight loss drug to be approved by the Food and Drug Administration in over 10 years. Now, complementing this with Phen Tabz helps to speed up the weight loss process safely and effectively without the negative side effects that come with anti-obesity drugs that require a prescription. There is no comparison available between the possible side effects of such weight reduction foods and weight loss pills like Qnexa (Qsymia). We already know that Phentermine also poses some undesirable side effects and weight loss effects are only for the short term. It has been over 13 years since the FDA has approved a prescription diet weight loss pill so it remains to be seen how the FDA will Qnexa / Qsymia. Those that are approved for prescription are only short term weight loss solutions including this pending approval for Qnexa by the FDA. Remember that even with approval from the FDA, Qnexa is still only for short term weight loss and will still require a doctor’s visit and assessment on whether the patient can take it or not. Today, Tuesday, July 17th, 2012 the FDA has approved the prescription weight loss drug Qnexa (renamed Qsymia) and limited it to highly obese patients with a body mass index of over 27 or more (BMI of 30 or greater). Please keep in mind that there are pharmacological products on the market that are safer and effective for weight loss and appetite suppression that DO NOT require a prescription like Phen Tabz . Phen Tabz : Qnexa alternatives without a prescription and without the negative side effects! more...



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. more...



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 . more...



New FDA Approved Weight Loss Drug Now Available

Qsymia is the first weight loss drug approved by the FDA in 13 years. Eva Cwynar says the drug “makes the stomach feel like it’s got enough food in there.” The drug is now available at retail pharmacies by prescription. “When I gained all the weight. This year, he finally decided that he wanted to lose the weight for good. They worked out a diet and exercise plan and used a new tool that recently became available  -  the first weight loss drug approved by the FDA in 13 years - called Qsymia . Cwynar said, “It makes the stomach feel like it’s got enough food in there.” “Normal Phenteramine on the market is 37 milligram, this has a 3 milligram as a starter dose. So it’s a fraction of what’s out there, and it doesn’t have the agitation, or the cardiac effects,” Dr. “The majority of patients that I put on this drug have absolutely no side effects.”   Brown says he has felt no side effects from the drug at all. “I feel rejuvenated, and I’m off in a whole new direction,” he said, “I’m excited for the new direction of life.” more...



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. more...



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? more...



FDA approves weight - loss drug Contrave - Refresh

Food and Drug Administration has approved a drug to help people lose weight. The new drug, Contrave, combines two generic drugs, naltrexone and bupropion. Neither naltrexone nor bupropion by itself has been approved for weight loss. Specifically, Contrave was approved for use by adults who are obese – a body-mass index of 30 or higher – and by overweight adults, with a BMI between 27 and 30, who have at least one other weight-related condition or illness, such as high blood pressure or Type 2 diabetes. 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 percent of those who took Contrave lost at least 5 percent of their body weight, compared with 17 percent of those who took a placebo. In a trial of people with diabetes, 36 percent of those taking Contrave lost at least 5 percent of their body weight, compared with 18 percent 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? Since the use of bupropion has been linked to the onset of suicidal thoughts, Contrave will carry the same black-box warning about this that bupropion does. more...



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. more...



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. more...



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. more...



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. more...



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. more...



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. more...



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. more...



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. more...



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. more...



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. more...



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. more...



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. more...



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. more...



New Weight Loss Drug Approved by FDA

“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. Therefore, response to therapy with the recommended daily dose of Qsymia should be evaluated by 12 weeks to determine, based on the amount of weight loss, whether to discontinue Qsymia or increase to the higher 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 FDA approved Qsymia with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a Medication Guide advising patients about important safety information and elements to assure safe use that include prescriber training and pharmacy certification. 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. more...



A New Medication for Weight Loss - The Dr. Oz Show

The New Silver Bullet for Weight Loss. Qnexa is a new, potent, effective and safe weight-loss drug that will help in the fight against obesity; it is poised to become the first FDA-approved weight-loss pill in 13 years. Qnexa is a combination pill of two medicines already on the market: phentermine and extended-release topiramate. It is now estimated that 2 of every 3 people are overweight, and about 30% of the population is obese. The studies that looked at Qnexa showed 9.8-14.7% weight loss, depending on the dose and the amount that you are overweight. At the time, we were using both phentermine and topiramate for weight-loss – but individually. Their side effects are quite different so that some patients did better on one drug and some did better on the other. For some, the phentermine’s effect is incomplete and adding topiramate has really helped. For most, adding the second drug boosts the appetite-suppressant effect and there is less hunger. more...



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. more...



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. more...



Qsymia – New Weight Loss Drug approved by FDA

Qsymia is a very exciting new weight loss drug approved by the FDA on July 17 2012. Qsymia is actually a combination of two different drugs, phentermine and topiramate, that are already approved and used widely. What’s the big deal about Qsymia? Note the “phen” is short for the same Phentermine used in Qsymia. In testing recognized by the FDA of 3,700 obese and overweight patients, average body weight loss of 9% was recorded for those taking the higher dosage of Qsymia. The other drug found in Qsymia, topiramate, helps you feel fuller meaning food won’t be as tempting as it once was. It was for this reason that Qsymia was denied approval from the FDA in 2010. The most common side effects that you could experience while taking Qsymia are: One of the most common vision problems that can occur while taking Qsymia is glaucoma. You should also be aware that Qsymia can cause new suicidal thoughts, mood swings and depression. Qsymia can cause birth defects and the risk begins very early, which means it could affect your baby if you take Qsymia even before you know you’re pregnant. Talk to your doctor about which birth control option is best for you while you’re taking Qsymia and continue to be tested each month for pregnancy. Only your doctor will be able to determine if Qsymia is a good choice for you after an in-depth medical review of past and current health. At first, Qsymia will only be available through select pharmacies that have received extensive training on the drug and its side effects. more...



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. more...



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. more...



FDA Panel Endorses Contrave Weight - Loss Drug - ABC News

- An FDA advisory committee has voted 13-7 that the modest weight-loss benefits of an investigational combination of naltrexone and bupropion - marketed under the brand name Contrave - outweigh the drug's blood pressure risk. The bupropion-naltrexone combo is the last in a trio of new weight-loss drugs that went before FDA panels this year, striving to be the latest treatment in the dwindling field of medications to fight obesity . The previous two drugs, phentermine/topiramate ( Qnexa ) and lorcaserin hydrochloride (Lorqess) were both rejected by the FDA after they fared poorly at advisory committee meetings. But Tuesday's advisory committee ended very differently than the previous two. Bupropion/naltrexone appeared to offer fewer side effects than the previous two drugs, although it also doesn't appear to work as well at helping obese patients lose weight. The Endocrine and Metabolic Drugs Advisory Committee reviewed results from Orexigen's four placebo-controlled, one-year, phase III clinical trials, which enrolled 3,200 obese patients with at least one comorbid condition, including diabetes and depression. more...



New Weight - Loss Drug Approved

Food and Drug Administration (FDA) has approved the first new prescription weight-loss drug in 13 years. In a ruling this week, the FDA okayed Arena Pharmaceuticals’ Belviq pill for adults who are either obese or overweight and have at least one medical complication, such as high blood pressure, high cholesterol or diabetes. “Additional tests provided sufficient reassurance of the drug’s safety profile and effectiveness,” Geehr says. Still, he notes, the FDA has called for even more safety studies after Belviq’s release. Studies found that about half of those taking Belviq for a year lost at least 5% of their body weight, compared with about a quarter of those taking a placebo, according to 2010 research published in the New England Journal of Medicine. According the manufacturer, if patients don’t lose 5% of their body weight in 12 weeks, the drug probably won’t work for them. D., scientific director for the Translational Research Institute for Metabolism and Diabetes in Orlando, Fla., in a follow-up editorial. D., associate director of psychology at the Center for Weight Loss and Cedars-Sinai Medical Center in Los Angeles. About a third of American adults are overweight, and another third are obese, according to the U. D., a cardiologist with the Providence Heart and Vascular Institute in Portland, Ore. At proper dosages, however, Belviq doesn’t activate the serotonin 2 B receptor, which was assumed to be responsible for the heart damage, the FDA said. “It makes sense for patients with serious valvular heart disease to check with their physician before taking the medication.” D., director of the FDA’s Center for Drug Evaluation and Research, in an agency press release. The information contained on www.lifescript.com (the "Site") is provided for informational purposes only and is not meant to substitute for advice from your doctor or health-care professional. Information and statements provided by the site about dietary supplements have not been evaluated by the Food and Drug Administration and are not intended to diagnose, treat, cure, or prevent any disease. more...



New Weight Loss Drug Saxenda Approved By FDA

New Weight Loss Drug Saxenda Approved By FDA. A new weight loss drug was approved by the FDA to be issued to obese people in conjunction with a low-calorie diet and exercise. 23 by the Food and Drug Administration (FDA). Before approving the drug Tuesday, the FDA evaluated Saxenda in three clinical trials that involved about 4,800 obese and overweight patients with and without significant weight-related conditions. The drug was only approved for obese adults with a body mass index (BMI) of 30 or greater, according the news release. more...



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. more...



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. more...



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? more...




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