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Qnexa Resubmits for FDA Approval with a New Clinical Trial

UPDATE [1/10/12]: The FDA announced this week that a major contraindication has been lifted from the weight loss drug Qnexa, broadening the potential market for the drug. Previously, the FDA was concerned that women of childbearing age who ingested one of the drug’s ingredients might have children with a higher rate of birth defects, but further research has shown the danger is only present for women who took the drug during pregnancy. Some experts expect the drug will be approved by the spring.

There is a new weight loss drug on the horizon. Qnexa, from parent company Vivus, Inc., consists of a combination of two prescription drugs – Phentermine and Topiramate. It has been effective in clinical studies at helping those who take it lose up to 15 percent of their body weight. There have also been indicators of increasing some cardiovascular actions. In addition, Qnexa also appears to improve sleep apnea, a condition in which those who suffer can stop breathing during their sleep cycles.

Phentermine is well known by dieters, but Topiramate has not been used in the weight loss field. It is prescribed as an anti-convulsant, but patients who have used it have reported weight loss as a side effect. It is also prescribed under the name Topamax for migraine use. Combining the two medications together has shown to increase the weight loss results of either drug when it was taken singly. Multiple levels of each drug have been combined in field testing, and the company feels that they have found the “magic” levels.

Qnexa works as an appetite suppressant, allowing a patient to eat markedly less and still feel full. It’s been hailed as the most effective weight loss medication since Fen-Phen.
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The Dangers of Phentermine

The FDA just rejected the prescription weight loss drug, Qnexa, because of its potential for adverse cardiovascular effects. While weight loss drugs are fraught with health risks, in regards to Qnexa, the finger points to the drug’s main ingredient, phentermine.

Phentermine is a kind of amphetamine that stimulates the nervous system, and increases heart rate and blood pressure. It is often used in diet pills because it suppresses appetite. Brand names of phentermine are Adipex-P, Obenix, Oby-Trim.

You might remember a weight loss drug called Fen-Phen. This dangerous diet pill was yanked from the market by the FDA in 1997 because of its association with serious cardiovascular problems. Phentermine was the “Phen” in Fen-Phen. Along with fenfluramine (“Fen”), the duo of ingredients was linked to heart and pulmonary emergencies, many of which resulted in death.


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FDA Rejects Diet Pill Qnexa

Qnexa, what would have been the first new weight loss drug in a decade, was rejected in a narrow vote by the Food and Drug Administration. They reported concerns about the lack of data about the pill’s cardiovascular effects. The committee voted 10-6 against Qnexa, created by Vivus, Inc., which contains one of the active ingredients found in Fen-phen. Fen-phen was taken off the market because it was linked to heart damage.


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Three New Weight Loss Pills Await FDA Approval [UPDATED]

Three new weight loss pills

UPDATE: FDA Rejects Qnexa (7/16/2010)

The Huffington Post reported that on Monday, the Food and Drug Administration is expected to release the review of Vivus Inc.’s pill, Qnexa. The first of three new weight loss drugs to be assessed by the FDA, Qnexa showed promising results in clinical trials. Patients lost between 13 and 15 percent of their body weight, but many who began the trial dropped out due to side effects, which included memory and concentration problems.
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