Posts tagged "FDA approval of Qnexa"

FDA’S ADVISORY BOARD FAVORS APPROVAL OF QNEXA, OBESITY DRUG: Side Effects Of Increased Heart Rate And Birth Defects Put Aside

FDA’S ADVISORY BOARD FAVORS APPROVAL OF NEW OBESITY DRUG: Side Effects Of Increased Heart Rate And Birth Defects Put Aside

February 23, 2012

Vivas’ drug, Qnexa, a combination of the stimulant, phentermine, and the migraine/epilepsy drug, topirimate (branded as Topamax) wasendorsed by the FDA’s advisory company, even though it  rejected the same drug in 2010.

Obesity Action Coalition’s president, Nadglowski, mentioned that members have been frustrated because of the limited choice of obesity options. An assistant professor, Morrato at University of Colorado, Denver, noted the need for “better pharmacologic options for individual patients” This sentiment plus the fact that obesity, itself, causes health problems, may have contributed to the 11 to 2 vote in favor of this endorsement.

The FDA often listens to their outside advisory team and will make a decision as to the status of the drug’s application by April 17, 2012.

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Publisher’s Note: 

According to some figures, 80% of people who lose weight gain it back within two years. A University of California-LA study found that two-thirds of the dieters in their study gained back more than they lost in four or five years.

According to drug company data, the same is true of weight gained back when a weight loss drug is stopped. There is much evidence that the use of stimulants as weight loss technique, even in conjunction with exercise,  do not allow the patient’s body and mind to adapt to a new way of thinking and eating. This seems to be the biggest reason for weight gain after weight loss. Of course, there are situations where temporary loss of weight is essential and drugs can assist in this effort.

Even though we need options for weight issues, it’s important to consider the benefits of gradual, drug-free strategies that increase our knowledge; develop our understanding of our bodies and how they interact with food and benefit our metabolism and our lifestyle so that we can maintain good weight and not gain it back when we eliminate a drug. Although it’s very tempting to try a newly approved drug which might be better than our current sitation, we must look at the data and be discerning, even if the FDA chooses to approve Qnexa.