New Fda Approved Drugs Weight Loss


FDA Approves 5 New Diet Drugs With Serious Side Effects


In the video above, John Fauber, a reporter who covered the issue last month for the Milwaukee Journal Sentinel , explains to Huff Post Live why the FDA felt the need to approve the new products and what it means for consumers. The history of diet drugs is really an abysmal history. All diet drugs have been over the years, over the decades associated with deaths and thousands of injuries. Update: Shire, the pharmaceutical company that developed the drug Vyvanse, reached out to Huff Post with the following comment: Sign up here for Live Today, Huff Post Live's new morning email that will let you know the newsmakers, celebrities and politicians joining us that day and give you the best clips from the day before!


read more

New Diet Drugs Hit the Market - ABC News


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


read 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.


read 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.


read 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.


read 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.


read 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.


read 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.


read more

New FDA - Approved Weight - Loss Device Targets Nerves In


The United States Food and Drug Administration (FDA) has just approved a new weight-loss device that works with the nerves in the brain, “tricking” it to believe that an individual is full. Are considered to be overweight, and 31 percent fall under the obese category. These are startling statistics when the actual numbers are calculated to be over 79 million people, and by all estimations, that number is only going to increase. If a person falls within the 25.0 to 29.9 range, they are considered to be overweight, and those falling within the 30 or higher range are considered to be obese. The device, called the Maestro Rechargeable System, is the first FDA-approved weight-loss device since 2007, and is developed by the Entero-Medics Corporation. The gadget itself isn’t large, and is similar in appearance to that of an insulin pump used by many diabetes sufferers. The pulses continue after a meal and convince the brain that the stomach is fuller longer than it actually is. Over half of the experimental group lost 20 percent of their body weight, and 38 percent lost 25 percent of their body weight. It is only being used for patients aged 18 and older who have not successfully lost weight with a traditional weight-loss program, and who have a BMI between 35 to 45. H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, weighed in on the issue. With weight and obesity being a near obsession in the United States and elsewhere, a new medical device approved for weight-loss is a beacon of hope for some.


read 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.


read more

New weight - loss drug available


Weight-loss drug Belviq is now available by prescription for overweight or obese patients. A new drug, Belviq, is available to overweight and obese patients. The drug received FDA approval nearly a year ago. The FDA approved Belviq, an oral medication, in June 2012. Belviq, as the FDA pointed out in its statement announcing approval last year, is intended "as an addition to a reduced-calorie diet and exercise." Patients in clinical trials went from an average 227 pounds to 204 pounds on Qsymia; on Belviq, the average weight dropped from 220 to 207. In trials, 47% of patients without Type 2 diabetes lost at least 5% of their body weight on Belviq, according to the FDA. In people with Type 2 diabetes, 38% of patients on Belviq lost at least 5% of their body weight, compared with 16% on a placebo. The most common side effects of Belviq in nondiabetic patients included headache, dizziness and fatigue, according to the FDA.


read more

New FDA Approved Drugs for 2016


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.


read more

Prescription weight - loss drugs : Can they help you


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.


read 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.


read 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.


read 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.


read 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.


read 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.


read 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.


read more

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.


read more

Hunger game : FDA approves new obesity fighter - USA TODAY


The Maestro Rechargeable System from Entero Medics (ETRM) is the first FDA-approved anti-obesity device since 2007. Hunger game: FDA approves new obesity fighter The Maestro Rechargeable System from Entero Medics (ETRM) is the first FDA-approved anti-obesity device since 2007. To find out more about Facebook commenting please read the Conversation Guidelines and FAQs. The FDA approved a new weight-loss device this week - the first in nearly a decade. The Maestro Rechargeable System is the first FDA-approved anti-obesity device since 2007. "I believe that if I lost the weight," she said, "I would not be a type-2 diabetic." The Maestro Rechargeable System from Entero Medics ( ETRM ) is the first FDA-approved anti-obesity device since 2007. Though the specific mechanisms for weight loss due to use of the device are unknown, according to the FDA, it's believed the Maestro's pulses trick the body into feeling full. Priscillla Hollander, who has researched and conducted many clinical trials on diet drugs, questions whether the Maestro's modest potential for weight loss is worth the risk of surgery. "Some of the patients lost 20% of their excess weight," Hollander said. External controllers allow the patient to charge the device. The device can be removed. The Maestro might control hunger pangs, but it doesn't address the psychology of food addiction. She knows cutting high-calorie soda and getting up from the desk is cheaper and safer than surgery.


read more

Anti - obesity medication - Wikipedia, the free encyclopedia


Orlistat (Xenical) the most commonly used medication to treat obesity and sibutramine (Meridia) a medication that was recently withdrawn due to cardiovascular side effects. [1] The main treatment modalities for overweight and obese individuals remain dieting and physical exercise . Because of potential side effects , it is recommended that anti-obesity drugs only be prescribed for obesity where it is hoped that the benefits of the treatment outweigh its risks. Current and potential anti-obesity drugs may operate through one or more of the following mechanisms: It was not until the 1920s and 1930s that new treatments began to appear. [13] Fen-phen was born and rapidly became the most commonly prescribed diet medication. Dexfenfluramine (Redux) was developed in the mid-1990s as an alternative to fenfluramine with less side-effects, and received regulatory approval in 1996. Ephedra was removed from the US market in 2004 over concerns that it raises blood pressure and could lead to strokes and death. Food and Drug Administration (FDA) has approved a revised label for Xenical to include new safety information about cases of severe liver injury that have been reported rarely with the use of this medication. In the past, it was noted by the US that Meridia was a harmless drug for fighting obesity. The combination of phentermine and topiramate , brand name Qsymia (formerly Qnexa) was approved by the U. Unresearched nonprescription products or programs for weight loss are heavily promoted by mail and print advertising and on the internet. [44] A similar medication designed for patients with Type 2 diabetes is Acarbose; which partially blocks absorption of carbohydrates in the small intestine, and produces similar side effects including stomach pain and flatulence. The limitation of - or knowledge gap concerning - drugs for obesity is that we do not fully understand the neural basis of appetite and how to modulate it. This was a novel combination of an inhibitor and a polymer designed to bind the undigested triglycerides therefore allowing increased fat expulsion without side effects such as oily stools that occur with orlistat.


read more

Diet Pills, Prescription Weight Loss Drugs, Appetite


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.


read 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.


read more

Diet Drugs Work : Why Won't Doctors Prescribe Them


I spent the next several minutes speaking with her about diet and exercise, the health risks of obesity , and the benefits of weight loss —a talk I’ve been having with my patients for more than twenty years. A.’s approval process for new medications in this week’s issue.) The drugs work by suppressing appetite, by increasing metabolism, and by other mechanisms that are not yet fully understood. Sales figures indicate that physicians haven’t embraced the new medications, Qsymia and Belviq, either. Several leading experts and researchers attending Obesity Week told me that the problem is that, while specialists who study obesity view it as a chronic but treatable disease, primary-care physicians are not fully convinced that they should be treating obesity at all. Kaplan thinks that if more doctors understood this, they’d view obesity treatment more receptively and realistically. We’re going to look back on obesity one day and say the same thing.” Obesity experts with whom I spoke tended to be more optimistic than other physicians about the possibility that obesity can be treated successfully and that the obesity epidemic will be curbed. But they remain concerned that despite such promising developments, many physicians still don’t see obesity the way they do: as a serious, often preventable disease that requires intensive and lifelong treatment with a combination of diet, exercise, behavioral modification, surgery, and, potentially, drugs. Louis Aronne thinks this will change as more physicians enter the field of obesity medicine, the physiology of obesity is better understood, and more effective treatment options become available. He predicts that, one day, “some doctors are going to look back at severely obese patients and say, ‘What the hell was I thinking when I didn’t do anything to help them? Patients like the woman who asked me to help her lose weight may not have to wait that long.


read 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?


read 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.


read 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.


read 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?


read more

FDA Approves New Weight - Loss Drug : Health and Medicine


The new medication can be used for obese or overweight adults to help them lose weight if they're struggling with at least one weight-related health problem such as hypertension or Type 2 diabetes. For the study, researchers conducted three trials that involved 4,800 obese or overweight participants with or without weight-related health conditions. All received healthy lifestyle counseling along with the drug, according to News Everyday . Findings revealed that non-diabetic participants on Saxenda lost an average of 4.5 percent in weight after one year, while 62 percent of those on the drug lost at least five percent of their body weight. In the placebo group, only 34 percent of the people lost about five percent of their body weight. For those who received Saxenda, close to 49 percent of them also lost at least five percent of their body weight. In the placebo group, another 16 percent achieved similar weight loss results. The window to the world of science news .


read 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.”


read 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.


read 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.


read 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.


read 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.


read 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.


read 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.


read 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.


read more

Copyright © vfxbyjames.info2017 | Sitemap