The FDA in 2010 had to reject the weight-loss drug, mainly in part of the same side effects of heart problems and birth defects in pregnant women who take the pill. However, Vivus, Inc., maker of the drug is still happening forward as they prepare for another effort to grant the agency’s approval.
Documents which have been released Friday by the agency show stay anxiety over the weight-loss drug.
On Wednesday, the advisory committee to the FDA will meet again to decide the fate of the weight-loss drug. One question posed at the committee is should Vivus be requisite to carry out one more large clinical trial to evaluate whether the drug increases the risk for heart attack along with assessing the risk for cleft lip, which has with one of the ingredients in Qnexa.
The committee, panel of doctors, will take a final vote for the fate of this drug as it emerges to safety and effectiveness. The committee’s suggestion is not binding but most often the FDA follows the committee’s suggestions. The FDA is expected to make a final decision in April.
Doctors are endorsed to recommend this drug due to off-label prescribing also known as unapproved use of prescribing a drug or medical device. There is no precise data regarding off-label prescribing, but estimates go as high as 60% of all drug prescriptions written in the US in a given year.
This new drug is a blend of two older drugs. Amphetamine phentermine, which has been approved for weight loss on a short-term basis. basis. The other ingredient topiramate sold as Topamax, an anti-convulsant drug sold by Johnson & Johnson. The two drugs collective aides in repress appetite and making persons feel fuller.
J.P. Morgan, biotechnology analyst Cory Kasimov, comment in a note to clients that the documents had enclosed ‘no big surprise’ and has left him ever more more positive of the outcome of the meeting.
Vivus in a declaration notes Qnexa is a low dose of both drugs and its planned use for weight loss is also in mix with diet and exercise. The company is not in support of off-labelling for phentermine and topiramate.
Dr. David Katz, co-founder of Yale University Prevention Research Center had noted that those side effects are the very concerns caused by obesity.
Phentermine was in the diet drug Fen-Phen. That in itself was reason enough for Dr. Charles Clark, professor of pharmacology and toxicology at Indiana University. Dr. Clark notes that the failure of Fen-Phen which left the market in 1977 after it basis fatal blood pressure and heart valve problems in patients.
Green tea fat burner has had its share of weight loss news other than not in a bad light. This green tea supplement burn the fatty acids in our body without increasing heart rate, assists to prevent fatty liver disease, heart failures and boosts the body’s metabolism.
Green tea has diuretic possessions thus it does recommend you boost your water consumption. Urine increase maybe observes due to the supplements serving your body toxins and water weight. Note that it should not be in glut. Just like other weight loss pills you need to follow a healthy diet and exercise.
With weight loss green tea gives supplementary benefits like lower cholesterol, cancer prevention and fights bacteria and fungus.