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Qnexa 12 articles

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

FDA approves Belviq, first weight loss drug in more than a decade

A new prescription weight-loss pill has been approved by the Food and Drug Administration (FDA), making it the first diet pill to hit the U.S. market in more than a decade. Arena Pharmaceuticals Belviq (lorcasserin) was deemed safe enough to get a nod by drug regulators, though the agency says studies showed only modest weight loss in clinical trials. Belviq was approved for adults who are obese or overweight with at least one medical complication such as diabetes or high cholesterol. The drug should be used with a healthy diet and exercise. The FDA first rejected Belviq in 2010 after ... 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 delays vote on experimental diet drug Qnexa

Approval for the experimental weight loss drug Qnexa has been pushed back another three months, paving the way for other drugs to stretch ahead in the race for the first diet pill in 13 years to be granted marketing rights in the United States. The Food and Drug Administration (FDA) pushed back the target date for approval to allow time to review a new safety plan submitted by drug maker Vivus Inc. These plans often include information that explains side effects and safety risks. Side effects reported with Qnexa include birth defects, heart palpitations, suicidal thoughts, and memory lapses. Vivus ... Read More

FDA advises diet drug makers to assess heart risks

Pharmaceutical companies who develop weight loss drugs need to study their medications to determine heart risks before seeking approval from health regulators, the Food and Drug Administration (FDA) said in a report released this week. Three drug companies are vying to get approval for what would be the first diet pills to hit the market in 13 years. Vivus’s drug Qnexa will be reviewed by an FDA panel in April, and Arena’s medication lorcasserin will be reviewed in May. Drug company Orexigen agreed in September to conduct safety studies on its diet pill, Contrave. Contrave hit a snag with FDA ... Read More

Experimental diet drug shows promise for those with type 2 diabetes

An experimental diet pill is one step closer to becoming available for people who are obese or overweight with conditions such as hypertension and type 2 diabetes. A Food and Drug Administration (FDA) advisory panel recommended the approval of Qnexa If the FDA follows the advice of the panel, as it most often does, then Qnexa will be the first weight loss treatment approved by the FDA in 13 years. The drug was reviewed by the FDA’s endocrinologic and metabolic drugs advisory committee, which voted 20-2 to recommend the drug’s approval. The vote was based on clinical trials that showed ... 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

FDA considers approval of diet drug despite birth defects, heart risks

Drug maker Vivus Inc., is hoping to win Food and Drug Administration (FDA) approval for its diet drug Qnexa this week after a rejection in 2010 due to serious health concerns. Experts say the chances of the weight loss drug being cleared are 50-50. Qnexa is a combination of two FDA-approved drugs. One is phentermine, the “safer” part of the fen-phen diet drug that was banned due to heart problems. The other active ingredient is topiramate, a drug used to treat seizures and migraines. Topiramate has side effects that include suicidal thoughts and birth defects. The FDA rejected Qnexa its ... Read More

FDA to consider diet pill with birth defects warning

California-based drug company Vivus Inc. is hoping to win Food and Drug Administration (FDA) approval for its experimental diet drug Qnexa, after it was rejected last October because of concerns that it may cause birth defects and increased heart rate. Vivus has resubmitted Qnexa as a treatment for obese or overweight patients with weight-related disorders such as high blood pressure or diabetes with a new warning that the drug should not be used by women of childbearing age. In addition to the new warning label, the resubmission also includes a risk evaluation and mitigation strategy. An FDA advisory panel is ... Read More