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.
With FDA’s recent approval of two new prescription weight loss drugs, marketed under the trade names Belviq and Qsymia , the outlook for successful drug therapies to fight our nation’s growing obesity epidemic has improved. Before these two approvals, there had not been a new weight loss drug approved by FDA in more than 13 years. These new products have received a great deal of media attention, but one aspect of their use not highlighted by the media is that these drugs are intended for chronic use as part of a comprehensive weight loss program that includes modifications to diet and increased exercise. Another point to keep in mind is that Belviq and Qsymia are both associated with potentially serious risks, which is a key reason why they are approved by FDA only for use in obese patients whose risk from the health consequences of obesity and its related health issues outweigh the risks associated with using the drug. For instance, among other adverse effects, Qsymia can cause birth defects and Belviq can cause a dangerous chemical imbalance called “serotonin syndrome.” Doctors and patients who are considering the use of these drugs as part of an individualized weight management program must carefully consider the potential benefits and the potential risks and carefully follow the label instructions for how to use these drugs safely and effectively, including stopping use of the drugs if weight loss is not achieved. After 13 years without a new weight loss drug on the market, Belviq and Qsymia represent new hope for many who have been struggling with obesity, and will be valuable tools in their efforts to overcome the condition. Finally, however, what may be most important to remember about these two new products is that they are not “cures” for obesity.
The Food and Drug Administration (FDA) has approved two new weight loss drugs – marketed as Belviq and Qsymia – within the last 30 days. The approval of these drugs will expand the treatment options available for the overweight and obese, but with modest weight loss and potential side effects, will consumers actually use them? Far from being a quick fix, Qsymia and Belviq are prescription medications that are intended to be taken for the rest of a person’s life. While the weight loss drugs help a person eat less and feel full with less food by controlling hunger and increasing satiety, weight loss relies on using them in combination with a healthy reduced-calorie diet and exercise. Women with reproductive potential are instructed to use effective contraception consistently while taking the weight loss medications. The general weight loss mechanism of Belviq (pronounced BEL-VEEK) and Qsymia (pronounced kyoo sim EE uh) is to control hunger. Average weight loss in participants taking Belviq compared to the placebo group ranged from 3 percent to 3.7 percent. In people with type 2 diabetes, about 38 percent lost at least 5 percent of their body weight compared to 16 percent of the placebo group. The safety and efficacy of Qsymia were evaluated in two clinical trials which included nearly 3,700 obese and overweight patients treated for up to one year. Average weight loss in participants taking Qsymia compared to the placebo group ranged from 6.7 percent (lowest dose) to 8.9 percent (recommended dose) The weight loss medications have been approved for marketing but are not yet available. Most patients will probably have to pay the total cost, as insurance companies have generally not covered the cost of weight loss drugs. The FDA approval of these two weight loss drugs helps to fill a void in treatment options for obesity and overweight, as few alternatives for weight loss assistance currently exist between diet and exercise programs and bariatric surgery.
On Tuesday, the Food and Drug Administration ( FDA ) approved Qsymia, the second new diet drug in a month, and the most effective of the weight-loss pills that the agency has considered in recent years. (MORE: A Brief History of Diet Pills and the FDA ) The drug is approved for obese adults with a body mass index, or BMI, of 30 or higher. Some doctors have already been prescribing the two drugs together for weight loss. In clinical trials, overweight and obese patients taking Qsymia for a year lost differing amounts of weight: on average, patients taking a middle dose of the drug lost 8.4% of their body weight; on a higher dose, patients lost 10.6%. Most of the weight came off in the first three months, so doctors should monitor patients at that point to see if the drug is working. The FDA notes that people who don’t lose at least 3% of their body weight by three months are unlikely to go on to lose any significant weight, so they should either be counseled to discontinue the drug or to try a higher dose (Qsymia will be available in two doses). If patients still don’t lose at least 5% of their weight after three additional months on the higher dose, they should quit taking Qsymia. The drug is designed to be used in conjunction with traditional weight-management strategies like diet and exercise. Doctors stress that because of the potential risks of the drug, dieters should not use the drug for cosmetic weight loss. It will also be available in specialized pharmacies that register for the right to sell the drug, where pharmacists have been educated about Qsymia’s risks and can pass that information along to patients and doctors. Safety concerns led the FDA to reject Qsymia’s first bid for approval in 2010, but the agency and Vivus have now put in place strategies to reduce risk: for example, women of child-bearing age who want to take Qsymia must test negative for pregnancy before starting the drug and are expected to use contraception and take a pregnancy test once a month while on the drug. People with recent or unstable heart disease or stroke are not recommended to take the drug because of the potential heart risks. Vivus has also agreed to continue monitoring Qsymia users for side effects after the drug reaches market; in particular, it will conduct a long-term cardiovascular outcomes trial to assess the effect of Qsymia on major events like heart attack and stroke. The FDA’s approval of Qsymia, after such a long diet-drug drought and despite the potential safety problems that plague weight-loss pills, marks a willingness to make new solutions available.
Belviq is the first new drug approved for weight loss in over a decade. The drug works on serotonin transmitters in the brain which causes this reaction and can actually make users feel like they are full and do not have to eat as much as they would without it. Holly Phillips said on "CBS This Morning: Saturday" that positive reaction from the drug is linked to satiety because when you "feel full, you eat less, and then we see the weight loss." She also said that it is not for anyone looking to lose weight; you have to fit into one of two categories. "The first are people who are obese, which means that your body mass index is 30 or higher, and the second group is for people that are overweight but with one condition related to your weight," she said. Philips said that the drug was considered to be effective, and people who took the drug lost around 3.7 percent of their body weight over the year when compared to those who took a placebo. She also said that in studies the drug worked better in non-diabetics than people who already were diagnosed with that disease.
Orlistat (Xenical) the most commonly used medication to treat obesity and sibutramine (Meridia) a medication that was recently withdrawn due to cardiovascular side effects.  The main treatment modalities for overweight and obese individuals remain dieting and physical exercise . Because of potential side effects , it is recommended that anti-obesity drugs only be prescribed for obesity where it is hoped that the benefits of the treatment outweigh its risks. Current and potential anti-obesity drugs may operate through one or more of the following mechanisms: It was not until the 1920s and 1930s that new treatments began to appear.  Fen-phen was born and rapidly became the most commonly prescribed diet medication. Dexfenfluramine (Redux) was developed in the mid-1990s as an alternative to fenfluramine with less side-effects, and received regulatory approval in 1996. Ephedra was removed from the US market in 2004 over concerns that it raises blood pressure and could lead to strokes and death. Food and Drug Administration (FDA) has approved a revised label for Xenical to include new safety information about cases of severe liver injury that have been reported rarely with the use of this medication. In the past, it was noted by the US that Meridia was a harmless drug for fighting obesity. The combination of phentermine and topiramate , brand name Qsymia (formerly Qnexa) was approved by the U. Unresearched nonprescription products or programs for weight loss are heavily promoted by mail and print advertising and on the internet.  A similar medication designed for patients with Type 2 diabetes is Acarbose; which partially blocks absorption of carbohydrates in the small intestine, and produces similar side effects including stomach pain and flatulence. The limitation of - or knowledge gap concerning - drugs for obesity is that we do not fully understand the neural basis of appetite and how to modulate it. This was a novel combination of an inhibitor and a polymer designed to bind the undigested triglycerides therefore allowing increased fat expulsion without side effects such as oily stools that occur with orlistat.
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.
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.
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.
In a clinical trial that included 233 patients with a BMI of 35 or greater, of the 157 patients who received active Maestro devices, 52.5% lost at least 20% of their excess weight and 38% of them lost at least 25% of their excess weight. Overall, the experimental group lost 8.5% more of their excess weight than the control group after 12 months. Though the Maestro is approved for treatment in adults over the age of 18 who have not been successful in losing weight with a program, and who have a body mass index of 35 to 45 with at least one other obesity-related condition (like type 2 diabetes), the FDA is requiring the company that makes the device to conduct a five-year post-approval study.
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.
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.
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.
Home | Non-food | Drug | Are the two FDA-approved weight loss drugs safe? Are the two FDA-approved weight loss drugs safe? Sunday Aug 31, 2014 (foodconsumer.org) - A report in JAMA Internal Medicine suggests that physicians should exercise caution when they consider giving their obese patients one of the two weight loss drugs, lorcaserin and phentermine/topiramate, which were approved by the Food and Drug Administration in 2012. Lorcaserin hydrochloride (Belviq) marketed by Eisai Inc and phentermine-topiramate (Qysmia) made by Vivus Inc are indicated for the long term weight loss. Both lorcaserin and phetermine/topiramate "have been associated with serious harms," according to the report. The authors caution that physicians and patients should approach the two weight loss drugs cautiously and obese patients who do not lose at least 5% weight within 12 weeks of taking either drug should discontinue the treatment, which is advised in the prescription information. The new weight-loss drugs, lorcaserin and phentermine-topiramate: slim pickings?
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.
Three FDA-approved medications for weight loss - KPLC 7 News, Lake Charles, Louisiana. Three FDA-approved medications for weight loss. There are two medications on the market now that have recently been approved by the Food & Drug Administration. "I'm down 36 pounds since the first of the year," he said. "There are a lot of people who want to lose weight," said Dr. Jadoon says there are three FDA approved weight loss medications on the market. Then there is Qsymia, the first long-term use weight loss drug that is a combination of phentermine and a seizure medication called topiramate. "It works in the brain and gives you early satiety," said Dr. Healthy diet and exercise plans lead to the most success with these medications and Willeford says he holds himself accountable with that each day.
“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.
Orlistat (Xenical), lorcaserin (Belviq), phentermine-topiramate (Qsymia), naltrexone-bupropion (Contrave) and liraglutide (Saxenda) are approved for long-term use. The combination drug Qsymia (phentermine and topiramate) increases the risk of birth defects. Thus, the Food and Drug Administration (FDA) required the manufacturer to have a risk evaluation and mitigation strategy (REMS). The combination drug Contrave contains naltrexone and bupropion. Liraglutide (Saxenda) is the newest drug to be approved for weight loss. Drug treatments for obesity: Orlistat, sibutramine and remonabant. Belviq (prescribing information). Qsymia (prescribing information). Contrave (prescribing information). Saxenda (prescribing information). Drugs in perspective: Liraglutide for the treatment of obesity.
Prescription Weight Loss Drugs. Eating less and moving more are the basics of weight loss that lasts. For some people, prescription weight loss drugs may help. Doctors usually prescribe them only if your BMI is 30 or higher, or if it's at least 27 and you have a condition that may be related to your weight , like type 2 diabetes or high blood pressure . Here's what you should know about the most common prescription weight loss drugs: orlistat , Belviq , Contrave, Saxenda, phentermine , and Qsymia . Before you get a weight loss drug prescription, tell your doctor about your medical history. How it works: Blocks your body from absorbing about a third of the fat you eat. Also, take a multivitamin at least 2 hours before or after taking orlistat, because the drug temporarily makes it harder for your body to absorb vitamins A, D, E, and K. All other prescription weight loss drugs curb your appetite, including the following.
Fda Approved Weight Loss Drugs. You Fda approved weight loss drugs should not be anxious about 1 week of overeating, it is normally the various other 51 several weeks that you need to remain true to the diet. A lot Fda approved weight loss drugs of people make an effort to use will power once it comes to smashing the habit of binge eating, nevertheless , this kind of never functions. Most importantly you currently have to have confidence in yourself and possess a very very clear diet and workout system, since or else you will end up being between the 95% of Fda approved weight loss drugs people, just who are not able to get rid of weight. If perhaps the struggle has recently been a lot, make an effort Fda approved weight loss drugs additional serious physical exercises this kind of as weight training and operating. Associated with diets, physical activity is usually going to help Fda approved weight loss drugs you shed pounds and tone your body. Fitness trainers Fda approved weight loss drugs will coach them the right way to exercise accurately in purchase to take full advantage of the performance of all their courses. Healthy Strategies to Fda approved weight loss drugs Get rid of Weight: Is Your Diet plan Doing harm to You. Certainly this could end up being true, in case Fda approved weight loss drugs you deprive yourself longer enough you can indeed shed unwanted weight but you can also end up in a hospital due to Fda approved weight loss drugs malnutrition. In so doing more common presumption was that the increased the calorie lowering the more quickly Fda approved weight loss drugs the fat fell into off. The Capsiplex is usually the wonderful product that has the significant component Fda approved weight loss drugs this kind of as red hot chili peppers. Studies have Fda approved weight loss drugs indicated that fat training upon it's own, with out diet, can lead to body fat loss. Such type of dietary fiber not only on helps in the loss of pounds but additionally definitely will assist in lowering degrees of Fda approved weight loss drugs cholesterol and also promote cardiovascular wellness.
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.
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.
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.
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?
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.
And, even the search for a magic weight-loss pill is falling short, said Drs. The Federal Drug Administration has approved few drugs for long-term weight loss, and some are no longer marketed because of safety issues, the researchers said. In 2012, though, the FDA approved two drugs for long-term weight loss, lorcaserin hydrochloride (Belviq; Eisai Inc) and phentermine/topiramate (Qsymia; Vivus Inc). The trials for both drugs could not exclude important cardiovascular harms. The researchers said the FDA shared many of these concerns and the agency did not approve either drug on their initial applications. Nevertheless, the FDA approved the drugs and required the companies to conduct post-approval trials to assess the harms.
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.
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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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.
What Is Belviq, the New Weight Loss Drug? Belviq is a new weight loss drug that just became available by prescription this past week, one of only two new weight loss drugs approved by the FDA in the last 13 years. Pharmaceutical companies create new drugs, experiment with them, then market them for the effects that they produce. Reliable clinical studies have shown that people given the drug lost weight slightly more than people given a placebo , even without instruction in weight loss protocols. In almost all cases, the weight loss was slight, and the weight was regained after the trials. One would assume, based on the results of the clinical studies, that eating drive was reduced by the drug. We must establish new behavior where we eat less, to the degree that we lose weight and keep it off. Many people have used The Anderson Method to do just that, some saying it was easy. If you can do that without drugs, that will be the best solution. After all, you don't want to be taking these drugs for the rest of your life, even if they are safe. My advice, if you want to try a drug to help with weight control, is to find an expert in these drugs (psychiatrists or psychiatric nurses) and try one that is known to be safe.
In 2013 the FDA approved one new drug and a new combination of 2 old drugs as adjuncts to lifestyle changes for chronic weight management. Qsymia (Vivus) is a fixed-dose combination of the weight-loss drug phentermine and an extended-release (ER) formulation of topiramate. OLDER DRUGS FOR WEIGHT LOSS 1 — The lipase inhibitor orlistat is modestly effective (patients have lost 2.5-3.2 kg more than with placebo over 1-4 years), but it causes unpleasant adverse effects such as flatulence with discharge, oily spotting and fecal urgency. 3-5 In the first trial (BLOOM), patients who lost ≥5% of their body weight after one year on lorcaserin were randomized to continue the drug or switch to placebo for a second year. By the end of the second year, patients who continued on lorcaserin had regained about 25% of the initial weight loss, and those who took lorcaserin during the first year and placebo during year 2 had lost an average of only 1.2 kg more than those who had taken placebo for both years. Adverse Effects – Headache, nausea, and dizziness were the most frequent adverse effects reported with lorcaserin in clinical trials. The discontinuation rates were 50%, 45% and 36% in the 3 studies. Dosage and Administration – The dosage of lorcaserin recommended by the manufacturer is 10 mg twice daily. In an extension of the CONQUER trial, patients who volunteered to continue their study regimens for an additional 52 weeks lost (in total after 2 years) an average of 9.3% (9.6 kg) and 10.5% (10.9 kg) of their body weight, compared to a loss of 1.8% (2.1 kg) in the placebo group. Adverse Effects – Adverse effects that occurred in > 5% of patients taking phentermine/topiramate ER and were significantly more frequent than with placebo included dry mouth, paresthesia, constipation, dysgeusia and, with the higher dose, insomnia. If a 3% weight loss is not achieved after 12 weeks on the 7.5/46 mg dose, the dosage may be increased to 11.25/69 mg for 14 days, and then to 15/92 mg. CONCLUSION — Both lorcaserin (Belviq) and the phentermine/topiramate ER combination (Qsymia) taken as adjuncts to diet and exercise may be effective in increasing weight loss in the first year of use, but much less so in the second year.
Patients taking Contrave, a combination of the two existing anti-depression and anti-addiction drugs bupropion and naltrexone, lost 6.1% of their total body weight in one clinical trial. These outcomes place Contrave squarely in line with Qsymia and Belviq, the two weight loss drugs that the FDA approved in 2012. Michael Cowley, who led the Contrave studies, says that bupropion and naltrexone’s anti-addictive properties and their effect on food cravings were not initially considered when they chose to combine the two into a fat loss drug. “That side of the equation became much clearer later on and is clearly an important part of it,” he says. The experiments, published in the journal Obesity in 2009, showed in mice that treatment with both drugs increased the firing of these neurons and decreased food consumption. The FDA decided that more efforts towards confirming Contrave’s cardiovascular safety were also warranted and required that these studies be conducted prior to official approval. “We know that much, but we don’t know the details,” he says. “The FDA needs to change its policy so that it approves drugs a little better,” Mechanick says. He adds that Contrave is a drug that works, and adding it to the arsenal of existing pharmaceuticals provides more options for each patient to find the right weight loss therapy.