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Weight loss drug near FDA approval Weight loss drug near FDA approval
The Federal Food and Drug Administration is close to allowing the release of a new weight loss drug, after an advisory panel recommended Qnexa... Weight loss drug near FDA approval

by Jeff Clemetson, Editor

The Federal Food and Drug Administration is close to allowing the release of a new weight loss drug, after an advisory panel recommended Qnexa be ruled safe for human consumption.

Qnexa could be the first FDA-approved weight loss drug in 13 years.

During clinical trials, Qnexa was shown to help weight loss by an average of 10 percent. Along with Qnexa’s success in reducing fat in obese patients, there were noticeable side effects, including increased heart rate, cardiascular problems and heart paputations. The advisory panel ruled that the benefits of a weight loss drug outweigh the risks of heart troubles, due to the obesity epidemic facing Americans today. The FDA panel recommended that people taking Qnexa be closely monitored for heart conditions as part of a large follow-up study to be paid for by the drug’s maker, Vivus, Inc.

This is not the forst time Qnexa has come up in front of the FDA for approval. In October of 2010, the FDA rejects Vivus, Inc.’s application for approval, citing the heart issues and other side effects as well as psychiatric problems and birth defects. Vius, Inc.’s latest application contains more follow-up information and better safety recommendations for the drug.

Qnexa is a combination of two drugs that act on the appitite of a person. Amphetamine phentermine suppresses the appetite and topiramate, an antiseizure and antimigraine drug, tricks the body into feeling satiated by food.

The FDA is expected to make a final ruling on Qnexa by April 17. The FDA has not approved a weight loss drug in over 13 years.

 

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