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phentermine 13 articles

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

Diet pill Qsymia sales sluggish but analysts say pill has blockbuster potential

About 14,500 people have filled prescriptions for the new diet pill Qsymia since it hit the market in September, and the number of prescriptions are growing each month. Qsymia became the first weight loss pill to be sold in the U.S. since 1999. It is intended to be a lifelong treatment to help overweight and obese people manage their weight. Qysmia is a combination phentermine, a stimulant that acts as an appetite suppressant, and topiramate, a drug used to treat seizures. Analysts speculate that it could become blockbuster drug within a few years, generating sales of $1 billion or more. ... Read More

New indications for Topamax mean more unborn babies may be exposed to side effects

The anti-epilepsy drug Topamax (topriamate) is being used for more conditions than to prevent seizures in epileptics. The Food and Drug Administration (FDA) has approved the Topamax for the treatment of migraine headaches in adults, and most recently for weight loss in combination with the stimulant phentermine in the brand name drug Qnexa. The new indications expand the usage of the anti-seizure drug, which means more individuals will be exposed to potentially dangerous Topamax side effects. Topamax has been shown to be effective in the prevention of seizures for those with epilepsy, and for those suffering from migraine headaches. It ... 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

FDA approves new medication for erectile dysfunction

Move over Viagra and Cialis, there’s a new erectile dysfunction drug in town, and it’s name is Stendra. The new drug, made by Vivus, got a nod from the Food and Drug Administration (FDA) just last week. It works in much the same way as its competitors, by inhibiting the same enzyme to increase blood flow to the penis. The drug will provide another option to the nearly 30 million men who suffer from erectile dysfunction, a condition in which men have difficulty getting or keeping an erection. Stendra, also known as avanafil, will come with the same side effect ... 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

FDA panel recommends approval of controversial diet drug Qnexa

A new diet drug may soon be available for people battling the bulge, but it may come at a price. This week, a Food and Drug Administration (FDA) advisory panel reviewed clinical data on the weight loss drug Qnexa and voted to recommend its approval despite rejecting its application a year ago due to serious health concerns. The FDA is expected to make a final ruling about the drug later this year, but the agency typically follows the recommendations of its advisory panels. If approved, Qnexa will be the first prescription diet pill to hit the United States market since ... Read More