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diet drug 20 articles

Heart safety trial on diet drug Contrave halted prematurely

Takeda Pharmaceuticals Co. is threatening to sever its partnership with Orexigen Therapeutics Inc. after a safety study on the diet drug Contrave was halted because trial data was released prematurely. Orexigen had announced last March – when only about 25 percent of the data was in – that early data from a clinical trial to evaluate cardiovascular outcomes with Contrave showed patients taking the obesity medication had a reduction in heart-related deaths. The information was released as part of a patent application. The Food and Drug Administration (FDA) criticized Orexigen for releasing the information too soon, saying the trial’s integrity had ... Read More

FDA approves new diet pill Contrave

A new prescription diet pill has been given clearance by the Food and Drug Administration (FDA) for marketing in the United States. Contrave, made by Orexigen Therapeutics, is a combination of bupropion, an antidepressant that is also used for smoking cessation, and naltrexone, a drug used to treat drug and alcohol dependence. Contrave is approved for overweight or obese patients with a body mass index (BMI) of 30 or higher, as well as people with a BMI of 27 or higher with at least one other health issue such as diabetes. Patients treated with Contrave lost an average of 4.2 ... Read More

Type 2 diabetes drug Victoza tested as potential diet drug

The type 2 diabetes drug Victoza (liraglutide) can help overweight and obese people without diabetes lose weight, according to a new multinational clinical trial, but the drug comes with some risks. Victoza, an injectable drug in a class of diabetes medications known as glucagonlike peptide-1 (GLP-1) agonist, was approved by the Food and Drug Administration (FDA) in January 2010 to help lower blood sugar levels in people with type 2 diabetes. In an effort to expand the indication to non-diabetics who are overweight, the medication was pitted against a placebo and the currently marketed anti-obesity drug Qsymia, a combination of ... Read More

European drug advisors reject Qsiva (Qsymia) diet drug based on safety concerns

Advisors for the European Union’s health agency has again recommended against approving the new weight loss drug Qsiva, made by Vivus Inc. The Committee for Medicinal Products for Human Use raised concerns about the cardiovascular safety of the drug, saying it would need more data proving its safety before it would reconsider its rejection. Qsiva is a combination of two FDA-approved drugs – phentermine, an appetite suppressant, and topiramate, used to treat epilepsy and migraines. Phentermine was part of the fen-phen diet drug cocktail that was popular in the 1990s, but was pulled from the market after studies showed the ... Read More

Drug company wants to speed review process for new diet drug Contrave

Orexigen Therapeutics Inc. is hoping the Food and Drug Administration (FDA) will grant its request to speed up the review process for its obesity drug Contrave. The agency rejected the weight loss drug in February 2011, saying it needed data from a large-scale study on the long-term cardiovascular effects associated with the medication before approval would be granted. Contrave is a combination of two medications already approved by the FDA – bupropion, which is the active ingredient in the antidepressant Wellbutrin, and the anti-addiction drug naltrexone. Contrave is designed to influence the hypothalamus in order to decrease food intake over ... Read More

New diet drug Qsymia may be rejected by European drug regulators

Qsymia, first diet drug to be approved in 13 years by the U.S. Food and Drug Administration (FDA), may not get clearance from the European Medicines Agency because of the potential for heart problems. A European Union advisory panel is expected to rule on the weight loss treatment sometime next month, but the drug’s maker Vivus Inc. says it has been getting some cold vibes from the group. If rejected, Vivus says it will file a new marketing application or appeal the decision. Vivus wants to market Qsymia in Europe under the name Qsiva. This summer, the FDA approved Qsymia ... Read More

New diet drug Qsymia now available by prescription

The much anticipated diet drug Qsymia is officially on the market. Qsymia, made by Vivus, is one of two new weight loss drugs approved earlier this year by the Food and Drug Administration (FDA), becoming the first diet pills cleared by the FDA in more than 13 years. Unlike other drugs for weight loss, Qsymia, and new rival Belviq, are considered “life-long” treatments for obesity and should be used along with a diet and exercise program. Though both help users lose weight, they work in entirely different ways. Belviq contains the active ingredient lorcaserin, which works by activating a part ... Read More

Qsymia makers worry generics may take bite out of profits

Makers of the new obesity drug Qsymia have significantly scaled back their profit expectations after concerns that doctors may prescribe the drug’s ingredients separately rather than the drug itself. Vivus Inc., had estimated profits of as much as $3.6 billion per year, but scaled back its estimate to $1.2 billion, causing Vivus shares to tumble 7.7 percent earlier this week. Qsymia was one of two new long-term diet drugs approved by the Food and Drug Administration (FDA) earlier this year, making the drugs the first weight loss medications to be approved in 13 years. Qsymia was thought to be the ... Read More

FDA approves two life-long prescription diet drugs

Two new medications are the first in 13 years to be approved by the Food and Drug Administration (FDA) for long-term weight management. Marketed as Belviq and Qsymia, the prescription drugs are designed to be taken for the rest of a person’s life – along with a healthy lifestyle – for obese and overweight people who have been unsuccessful in getting their weight under control with diet and exercise. More than a third of adults in the United States are obese, and obesity contributes to a number of health conditions including high blood pressure, type 2 diabetes, and high cholesterol. “For ... Read More

Dr. Oz show investigates risks, benefits of new diet drug

An investigational diet drug is getting media attention from celebrity doctor Dr. Oz as the “New Silver Bullet for Weight Loss,” but the Food and Drug Administration (FDA) has yet to approve the drug based on health concerns including heart problems and birth defects. The new drug, made by Vivus, is Qnexa, a combination of phentermine and topiramate. Phentermine is a stimulant that is FDA approved as a diet pill to aid in weight loss. It was once part of the wonder drug fen-phen, which was banned in 1997 for damaging heart valves. Tropiramate, also known by the brand Topamax, ... Read More