Saturday, April 9 2016 12:09 PM EDT 2016-04-09 16:09:54 GMT. Friday, April 8 2016 4:36 PM EDT 2016-04-08 20:36:57 GMT. Friday, April 8 2016 4:07 PM EDT 2016-04-08 20:07:49 GMT. Saturday, April 9 2016 10:06 AM EDT 2016-04-09 14:06:28 GMT. Saturday, April 9 2016 10:35 AM EDT 2016-04-09 14:35:00 GMT. Friday, April 8 2016 9:54 PM EDT 2016-04-09 01:54:38 GMT. Thursday, April 7 2016 3:55 PM EDT 2016-04-07 19:55:05 GMT. Friday, April 8 2016 11:26 PM EDT 2016-04-09 03:26:53 GMT. But Baptist Health weight loss surgeon John Oldham says his patients have seen the best results with it. Nowak says Qsymia suppressed his appetite while he got used to a regular exercise routine and learned to cut the carbs.
What are weight loss drugs and how do they work? Taking a weight loss drug may not result in weight loss by itself. Signals to indicate fullness come from fat cells and the gastrointestinal tract; these converge with signals in the central nervous system. Only one drug among the weight loss medications works in a different way.
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New US Obesity Guidelines: Treat the Weight First. A new Endocrine Society clinical-practice guideline on the pharmacological management of obesity outlines a plan for the use of weight-loss agents as well as for shifting away from drugs to treat other conditions that promote weight gain. The document represents "a blueprint for how to treat obesity with comorbidities," Dr Caroline M Apovian (Nutrition and Weight Management Center at Boston Medical Center, Massachusetts) said during a telephone press briefing to introduce the guidance. Dr Apovian, who also served on that writing panel, pointed out that the 2013 guidelines covered lifestyle, medications, and surgery but didn't go into detail about pharmacotherapy because there were few drugs available in the United States at the time it was written. But in the past 4 months, the US Food and Drug Administration has approved bupropion/naltrexone (Contrave, Orexigen Therapeutics) and liraglutide (Saxenda, Novo Nordisk) for weight loss. "The addition of these medications to the lifestyle program will result in greater weight loss overall and better maintenance of the weight loss." And this is the first guidance "that specifically names the medications and the recommended doses and how to use them. There are patient selection criteria that go beyond the [body mass index] and actually talk about other comorbidities and which drugs we might suggest and which drugs to taper the patient off of," she noted. The guidelines advise treating the weight first with lifestyle modification and medication and then managing the remaining comorbidities that have not responded to any weight loss, including hyperglycemia, hypertension, and dyslipidemia. But for the most part, there isn't a lot of evidence for tailoring the medications, Dr. If the patient doesn't lose 5% of their weight in 12 weeks, stop the drug and try another. And many payers now cover bariatric surgery, too, but unfortunately most don't cover the weight-loss drugs.
Weight Loss Drugs. What is Weight Loss? Sometimes diet and exercise are not enough. Medication can be taken to aid in weight loss. Common drug classes used to aid in weight loss are central nervous system stimulants, lipase inhibitors, sympathomimetics, and growth hormone releasing factors. Popular Weight Loss Drugs. Weight Loss Drug Classes. Central nervous system stimulants are used to treat ADHD, narcolepsy, and aid in weight loss by increasing certain activity in the brain to speed up mental and physical processes. Sympathomimetics are used to aid in weight loss. They are used along with diet and exercise to suppress the appetite. Opioid antagonist / atypical antidepressant combination drugs are used in combination with diet and exercise to help with weight loss in obese or overweight patients. Lipase inhibitors are used to aid in weight loss.
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.
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.
Drug treatments for obesity: Orlistat, sibutramine and remonabant. Xenical (prescribing information). Belviq (prescribing information). FDA approves weight-management drug Qsymia. Qsymia (prescribing information). FDA approves Qsymia, a weight-loss drug. Didrex (prescribing information). Suprenza (prescribing information). Tenuate (prescribing information). Bontril (prescribing information). Contrave (prescribing information). FDA approves weight-management drug Contrave. FDA approves weight-management drug Saxenda. Saxenda (prescribing information).
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.
The following database contains a listing of drugs approved by the Food and Drug Administration (FDA) for sale in the United States. Taltz (ixekizumab) ; Eli Lilly; For the treatment of plaque psoriasis, Approved March 2016. Onzetra Xsail (sumatriptan nasal powder) ; Avanir; For the treatment of migraine, Approved January 2016. Idelvion (Coagulation Factor IX (Recombinant), Albumin Fusion Protein) ; CSL Behring; For the treatment of hemophilia B, Approved March 2016. Kovaltry [Antihemophilic Factor (Recombinant)] ; Bayer ; For the treatment of hemophillia A, Approved March 2016. Zepatier (elbasvir and grazoprevir) ; Merck; For the treatment of chronic HCV genotypes 1 or 4 , Approved January 2016. Odefsey (emtricitabine, rilpivirine, and tenofovir alafenamide) ; Gilead Sciences; For the treatment of HIV-1 as initial therapy, Approved March 2016. Anthim (obiltoxaximab) ; Elusys Therapeutics; For the treatment of inhalational anthrax , Approved March 2016. Cinqair (reslizumab) ; Teva Pharmaceuticals; For the treatment of severe asthma, Approved March 2016.
The FDA has declined to approve the investigational weight-loss pill Qnexa, doses of the new drug, compared with 10 percent of patients taking placebo. Before these two new drugs, the last prescription weight-loss pill to be. The new pill, formerly known as Qnexa (the FDA asked Vivus to . The weight loss pill Qsymia is now for sale from certified online to Vivus Pharmaceuticals - is the first new weight loss drug to reach market in. Vivus chose the name Qsymia after the FDA rejected a previous name, Qnexa. Qsymia, Qnexa, weight loss drug, obesity pill. The product will be sold under a new name, Qsymia. Nov 3, 2011, FDA Accepts New Drug Application Filing for Qnexa. New weight loss drug qnexa. Qnexa® is the brand name of the medication produced by Vivus. Qnexa is a combination drug of topiramate and phentermine being studied for the treatment of obesity. There is a study that reveals the similarities of Qnexa / Qsymia to other prescription weight loss pills and that they can increase the chances of heart attacks and.
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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.
With more than 36 percent of American adults now classified as obese according to the Centers for Disease Control and Prevention, and the numbers still climbing, doctors are clamoring for more pharmaceuticals to treat their patients. But even as doctors have begun scribbling prescriptions for these new weight loss medications, many dieters remember the long and checkered past of diet drugs in this country. Some drugs that were originally viewed as rock stars for weight loss and appetite control were ultimately pulled off the market after it was found they posed serious health risks. "Once people stopped losing weight they would take more and more of the pills, and this left some feeling racy and agitated with a rapid pulse and high blood pressure," said Dr. By the 1970s, the FDA limited its use for weight loss to short-term treatment only. Riding the wave of the supplement's popularity a similar drug named dexfenfluramine and marketed as Redux was quickly approved by the FDA in 1996. Approved in 1997, the drug was found during clinical trials to increase heart rate and blood pressure. The drug's risks proved not to be worth the benefits: Studies found a 16 percent increase of major cardiac events in patients taking Meridia compared with those who weren't taking the drug, with a negligible difference in weight loss. Done often enough, the drug is not as effective and weight loss is minimal. Belviq is approved for the obese and those who are overweight and have other serious health risks. In clinical trials, the average person lost 3 percent to 3.7 percent of his weight after taking Belviq for a year compared to those taking a placebo. The FDA said patients should stop taking Belviq if they fail to lose 5 percent of their body weight after three months of use. Patients are unlikely to see any significant weight loss by staying on the drug, the agency said. About half of the 4,430 overweight and obese patients in the Qsymia studies on the recommended dosage lost an average of 10 percent of their weight in the first year of taking the drug. We are talking about taking a pill to fix what's busted - the circuitry of the brain that misreads the signals of appetite, fat storage and other factors.
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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.
They also identify weight ranges that could increase the likelihood of certain health problems, such as type 2 diabetes and heart disease. There are three new drugs that may aid in obesity management: the recently approved weight-loss medications lorcaserin (Belviq), phentermine and topiramate (Qsymia), and naltrexone and bupropion (Contrave). The three medications have been shown to improve A 1 C levels of people with type 2 diabetes in clinical trials, says W. “In each case, [the medication] led to the lowering of the hemoglobin A 1 C, and at the same time there was decreased need for conventional diabetes medication,” he says. The weight-loss meds were also associated with a decrease in blood pressure and an improvement in abnormal lipids (blood fats such as cholesterol), an amazing result for people with type 2 diabetes, Garvey says. Qsymia is a combination of two medications that have been around for a long time and work in two different ways, though the exact mechanism is unknown. Multiple studies have shown that modest weight loss, a drop of between 3 and 7 percent of body weight, will improve diabetes control, says Kushner. People may not reach an ideal body weight or see the exact cosmetic change they want, but it will make a big difference in their metabolism and diabetes, says Garvey. “These medicines produce between 5 to 10 percent loss in body weight, on average, in people with diabetes, and it’s always over and above whatever the lifestyle intervention does by itself,” he says. Aside from that, both Garvey and Kushner agree that modest weight loss is enough to make a big difference in the management of type 2 diabetes. The indications for use, as defined by the Food and Drug Administration (FDA), are the same for all obesity drugs, including these three. If for some reason diabetes medications were not initially reduced, Kushner says he’d insist that the individual monitor his or her blood glucose very carefully and anticipate that it will be lower. In the past, Garvey says weight loss was not emphasized as a primary indication for the use of medications because safe and effective drugs weren’t available. “We have three new medications, and perhaps a fourth [Saxenda, below] on the way, and the weight loss indication increases our options for [diabetes] therapy,” he says. Garvey says we now have tools that can prevent or delay the progression to type 2 diabetes in overweight and obese people.
15 photos: Weight loss through history: The good, bad and scary. Weight loss drug Saxenda was approved in December, the latest in the pack of obesity treatments. The most effective weight loss drugs are typically associated with only 5% to 10% loss in body weight. The latest medication to join the pack is Saxenda, the name for liraglutide, which the Food and Drug Administration approved in December. "Some people are more worried about the cosmetics of being obese and they may not be as happy as one could be," Siraj said. Experts consider Qsymia, an oral medication, to be one of the most effective drugs, but it's only associated with between 5% and 10% weight loss among most patients. A recent study found that 33% of participants taking the injectable medication lost more than 10% of their body weight and 63% lost at least 5%. Among the control group, which only received advice about diet and exercise, 11% of participants lost more than 10% of their body weight, and 27% of participants lost at least 5%. Angela Fitch, director of medical weight management at the University of Cincinnati and a diplomat of the American Board of Obesity Medicine. Saxenda is the first in a class of diabetes medications called glucagon-like peptide-1 mimetics to be approved for weight loss. The current study found that the most common side effects of Saxenda were nausea and vomiting. The most serious side effects were pancreatitis and breast cancer, which affected less than 1% of participants in the Saxenda group.
The new prescription medications are designed for people who are obese or for those who are overweight and have other weight-related medical problems. Two new diet drugs can boost weight loss by 5% to 10% The new prescription medications are designed for people who are obese or for those who are overweight and have other weight-related medical problems. The price that patients will pay depends on their insurance coverage and may vary between pharmacies, he says. "We are looking at a whole range of options for patients who don't have insurance ( belviq.com ) and need financial support for the medication." About 89,000 prescriptions were written for Qsymia from the launch through March, he says. The company is offering the medication for no charge for the first two weeks, and a 50% discount for the first month of treatment, he says. These medications are new "tools in the toolbox" for doctors who are treating obese patients, says Harvey Grill, president of the Obesity Society, and a professor of behavioral neuroscience at the University of Pennsylvania. There are several other new obesity drugs on the horizon, and many others being investigated now, he says. C., lost weight on Belviq when she took it for two years during one of the drug's trials. Still, there are concerns about the side effects and risks of both drugs.
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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.
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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 has determined that the products you offer for sale, “Pink Bikini (White Capsules),” “Pink Bikini (Blue Capsules),” “Shorts on the Beach (Blue Capsules),” and “Shorts on the Beach (Golden Edition)” are unapproved new drugs under sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U. FDA confirmed through laboratory analysis that your products, “Pink Bikini (White Capsules),” “Pink Bikini (Blue Capsules),” “Shorts on the Beach (Blue Capsules),” and “Shorts on the Beach (Golden Edition)” contain the following undeclared active pharmaceutical ingredients: You market your Pink Bikini and Shorts on the Beach products as dietary supplements. Therefore, “Pink Bikini (Blue Capsules),” “Shorts on the Beach (Blue Capsules),” and “Shorts on the Beach (Golden Edition),” all of which contain sibutramine, are excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(ii) of the FD&C Act. Your “Pink Bikini (White Capsules),” Pink Bikini (Blue Capsules),” “Shorts on the Beach (Blue Capsules),” and “Shorts on the Beach (Golden Edition)” products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body and, thus, are drugs as defined by section 201(g)(1) of the FD&C Act [21 U. In addition, your “Pink Bikini (White Capsules),” “Pink Bikini (Blue Capsules),” “Shorts on the Beach (Blue Capsules),” and “Shorts on the Beach (Golden Edition)” are also new drugs under section 201(p) of the FD&C Act [21 U. There are no FDA-approved applications on file for “Pink Bikini (White Capsules),” “Pink Bikini (Blue Capsules),” “Shorts on the Beach (Blue Capsules),” and “Shorts on the Beach (Golden Edition).” The distribution or sale of these products without approved applications violates these provisions of the FD&C Act. Furthermore, “Pink Bikini (White Capsules),” “Pink Bikini (Blue Capsules),” “Shorts on the Beach (Blue Capsules),” and “Shorts on the Beach (Golden Edition)” are also “prescription drugs” as defined in section 503(b)(1)(A) of the FD&C Act [21 U. Because there are no FDA-approved applications for your firm’s “Pink Bikini (White Capsules),” “Pink Bikini (Blue Capsules),” “Shorts on the Beach (Blue Capsules),” and “Shorts on the Beach (Golden Edition),” their labeling fail to bear adequate directions for their intended use, causing them to be misbranded under section 502(f)(1) of the FD&C Act [21 U. .” The failure to disclose the presence of diclofenac, sibutramine and/or phenolphthalein renders the labeling of your “Pink Bikini (White Capsules),” “Pink Bikini (Blue Capsules),” “Shorts on the Beach (Blue Capsules),” and “Shorts on the Beach (Golden Edition)” misbranded under section 502(a) of the FD&C Act. “Pink Bikini (White Capsules),” “Pink Bikini (Blue Capsules),” “Shorts on the Beach (Blue Capsules),” and “Shorts on the Beach (Golden Edition)” are also misbranded under section 502(f)(2) of the FD&C Act [21 U. Likewise, “Pink Bikini (Blue Capsules),” “Shorts on the Beach (Blue Capsules),” and “Shorts on the Beach (Golden Edition)” are misbranded under section 502(j) of the FD&C Act, [21 U.
Weight-loss drug Belviq is now available by prescription for overweight or obese patients. A new drug, Belviq, is available to overweight and obese patients. The drug received FDA approval nearly a year ago. The FDA approved Belviq, an oral medication, in June 2012. Belviq, as the FDA pointed out in its statement announcing approval last year, is intended "as an addition to a reduced-calorie diet and exercise." Patients in clinical trials went from an average 227 pounds to 204 pounds on Qsymia; on Belviq, the average weight dropped from 220 to 207. In trials, 47% of patients without Type 2 diabetes lost at least 5% of their body weight on Belviq, according to the FDA. In people with Type 2 diabetes, 38% of patients on Belviq lost at least 5% of their body weight, compared with 16% on a placebo. The most common side effects of Belviq in nondiabetic patients included headache, dizziness and fatigue, according to the FDA.
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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.
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.
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.
But it may also be due to the drugs’ modest effectiveness and safety concerns, according to two Dartmouth researchers who wrote a column warning about the drugs’ unknown health risks in the February 10 issue of JAMA Internal Medicine . Insurance plans more readily reimburse for far more expensive weight loss surgeries, such as gastric bypass, to reverse obesity than they do for lorcaserin (Belviq) or phentermine-topiramate (Qysmia), the two new drugs. But that may not be a bad thing, until more is known about their long-term side effects, the doctors argue. “The drugs have been associated with serious harms.” They’re referring to uncommon side effects seen in clinical trials that are listed on the drugs’ labels, including memory loss, attention difficulties, language problems, and depression. Qsymia’s website warns about the drug’s potential to increase heart rate, trigger suicidal thoughts and actions, and cause serious eye problems, including a sudden decrease in vision. In deciding to sign off on the two weight loss drugs—the first approved in more than a decade—the US Food and Drug Administration determined that the chronic health problems associated with being obese outweigh risks associated with the drugs. But the agency also required that the manufacturers continue to conduct safety trials to learn more about the side effects. Woloshin and Schwartz wrote that these “safety trials are behind schedule” and “until there is more convincing evidence about the cardiovascular safety of these drugs, physicians and patients should approach them cautiously.” That’s advice also provided by the manufacturers, but doctors may not be heeding it.
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And those who do prescribe these drugs do so for only about one quarter of their obese or overweight patients. When her weight loss plateaued, she started working with a trainer and continued to progress. We opted for phentermine-topiramate ER because she had tolerated the separate components well and her insurance plan covered that medication. Now at the 1-year mark, she weighs 213 pounds and her BMI is 34.9. She continues on the drug and has kept the weight off. We discussed options for pharmacologic therapy, and she opted for lorcaserin (Belviq®) because this was the only option covered by her insurance plan. Dr Cowen: No, these drugs do not work for everyone who is overweight, and I do not prescribe them to everyone who asks. Patients who do not have good exercise and dietary habits are most likely to be unsuccessful on these medications, and they are also more likely to gain the weight back once they stop taking the medication. These patients usually do not meet the recommended weight loss at the 3-month mark as described in guidelines and package inserts. Medscape: You know other physicians who will not prescribe these drugs, and you know of practices that are now marketing themselves solely as "weight loss clinics"; what do you think about physicians on either end of the spectrum? The majority of patients I have on these drugs are still paying cash, and the reality of the matter is that not everyone has an extra $50-$150 per month lying around.
The FDA wasn't expected to approve the medication because a panel of outside experts voted in 10-6 in July against recommending approval for the combination drug - made by Vivus - which was shown to be effective in helping obese and overweight patients lose an average of 6-10 percent of their body weight in the company's clinical trials. At the meeting, one panelist said the drug is "far superior to anything on the market;" however, concerns over psychiatric and cardiovascular issues uncovered in the company's trials ultimately trumped the weight-loss benefit. The drug combines low doses of two approved drugs: phentermine, an appetite suppressant that was the most widely prescribed obesity drug in 2009, and topiramate, an anti-seizure medication that increases the feeling of being full and satisfied. Cardiovascular safety was also a prominent concern, largely because half of the combination is phentermine, a component of Fen-Phen, the popular fenfluramine/phentermine obesity drug that was pulled from the market about six months after its approval in 1997 because of an increased risk of heart valve problems. Data from the company's trials didn't indicate an increased risk of valvulopathy, although the drug did increase heart rate. In its decision letter to Vivus, the FDA requested that Vivus provide evidence that the elevation in heart rate does not increase the risk for major adverse cardiovascular events, according to a press release from the company. During the FDA advisory committee meeting, the panel was concerned about a lack of data on the possible link to birth defects if a woman were to become pregnant while taking the drug. Vivus said it will respond to the FDA within six weeks and provide new analyses that show Qnexa does not increase the risk for major cardiovascular events. Less than a week ago, the FDA notified Arena Pharmaceuticals that it will not approve the company's investigational weight loss drug lorcaserin, in part because data from animal studies suggest that lorcaserin increased the risk of mammary adenocarcinoma in rats.
New medications, which may be safer than earlier drugs, have expanded the options for treating obesity. Four medications approved by the FDA since 2012—Qsymia (phentermine and topiramate), Belviq (lorcaserin), Contrave (naltrexone and bupropion ) and Saxenda (liraglutide)—have added to the options for treating obesity, says Dr. "We now have six FDA-approved drugs, but that is a tiny percentage of the number available to treat hypertension and other chronic diseases, so we need even more options to treat obesity most effectively." Will the new drugs help you? Like older medications, the new drugs are best used as part of a comprehensive weight-loss program that includes close monitoring by an experienced physician. The approved drugs are meant for people with a BMI higher than 30, as well as for those with a BMI of 27 or higher who have other conditions such as type 2 diabetes, high blood pressure, joint problems, or sleep apnea, which can often be alleviated by losing weight. It often requires trying multiple medications to find the right one for each person. The weight-loss drugs won't melt off the pounds overnight. You may remember some disturbing reports about previous weight-loss medications. The ingredient phentermine—a component of Adipex-P, Ionamin, and Qsymia—isn't usually recommended for people who have high blood pressure or other heart conditions. Some weight-loss medications contain drugs used to treat other conditions. You may want to consider a "dual-purpose" medication if you have the following:
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