Once rejected weight loss drug now has approval despite risks of medication
Despite the concerns which have raised over this weight loss drug due to increased risk for heart attack, increased risk for cleft lip along with an increase in blood pressure and heart rate, the panel has overwhelmingly gave their endorsement for Qnexa.
In what some view as a surprising vote the committee, a panel of doctors for the FDA had cast a final vote of 20 to 2 in favor of the drug.
It appears very likely the reasoning for the panel backing is due to the drugs weight loss effects with patients having a ten percent loss of their overall weight with being on the medication for a one year period.
The final decision is not expected until mid April from the FDA. Vivus, who manufactures the drug is not totally in the clear yet for approval. The committee has placed emphasis that Vivus must be required to conduct a large follow-up study of the drugs effect on the heart. It was not more than a week ago Director and Research Analyst, Simon Simeonidis, at Indiana University had stated he had expected a new cardiovascular trial would be required before final approval. It appears Simeonids was apparently correct as the committee notes it is still uncertain if the side effects lead to heart attack and more serious cardiovascular issues.
Some physicians believe Qnexa is a good thing such as Dr. Elaine Morrato, assistant professor, DRPH, MPH, CPH, at Colorado School of Public, who believes that Qnexa did demonstrate a meaningful efficacy benefit noting that there are consequences to obesity. Dr. Morrato is not the only one who holds belief for this drug. Dr. Kenneth Burman, Internal Medicine, Endocrinology, at Washington Hospital Center, states “The potential benefits of this medication seem to trump the side effects, but in truth, only time will tell.”
The factor noted if Vivus conducts the study prior to market approval it could cost millions and could take up to three years or longer. Vivus may be able to conduct the study after granted approval.
This new drug is a combination of two older drugs. Amphetamine phentermine which has been approved for weight loss on a short term basis. The other ingredient topiramate sold as Topamax, an anti-convulsant drug sold by Johnson & Johnson. The two drugs combined aides in suppressing appetite and making persons feel more full.
Vivus has noted before that this new weight loss drug is a low dose of both drugs and is to be used in combination of diet and exercise. The company also does not support off-labeling practices of phentermine or topiramate.
If Qnexa receives approval FDA scientists have stated that they would require the company to train prescribers in the pregnancy risks of the drug along with the distribution of warning pamphlets.
If Qnexa is granted approval it will be the first drug approved in thirteen years.
In 1959, Phentermine (Fen-Phen) was granted approval but nearly forty years later the drug had left market due to causing fatal blood pressure and heart valve problems in patients.
Currently weight loss drug Xenical is the only long term weight-loss drug on the market. It is known by Alli the over-the-counter weight-loss drug since 2007 but accumulating side effects have been noted since last April.
Last year Penn State University researchers had revealed that green tea just may aide in putting a halt to those extra pounds from piling on. Green tea fat burner has received its shares of praises. It appears the green tea supplements burn the fatty acids in the body without increasing heart rate. It should not be used in excess water consumption is needed due to the fact the supplement has diuretic properties.
You should not use if you are pregnant or nursing. If you have a history of liver, kidney or stomach problems check with your doctor before using this supplement.
With the supplement exercise and proper diet is also needed.
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