Qnexa, poses potential risks of heart problems and birth defects
The FDA in 2010, had rejected the weight loss drug mostly 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 proceeding forward as they prepare for another attempt to grant the agency's approval.
Documents which have been released Friday by the agency shows remained concern over the weight loss drug.
On Wednesday, the advisory committee to the FDA will meet once again to decide the fate of the weight loss drug. One question posed at the committee is should Vivus be required to conduct a new 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. Also in the discussion the increased rate of blood pressure and heart rate.
The committee, panel of doctors, will take a final vote for the fate of this drug as it appears to safety and effectiveness. The committees recommendation is not binding but most often the FDA follows the committees recommendations. The FDA is expected to make a final decision in April.
According to some obesity specialists who have prescribed the combination of active ingredients in this drug have noted it has aided patients to lose pounds where other means to weight loss have failed.
Doctor's are allowed to prescribe this drug due to off-label prescribing also known as unapproved use of prescribing a drug or medical device. There is no accurate data concerning off-label prescribing but estimates go as high as 60% of all drug prescriptions written in the United States in a given year.
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.
Reported in company trials patients had loss over 10% of their body mass. On the second year of one clinical trial it had showed those who took the drug had regained ten to twenty percent of the weight they had lost in the first year by taking the drug.
J.P. Morgan, biotechnology analyst Cory Kasimov, remarked in a note to clients that the documents had contained “no big surprise” and has left him increasingly more positive of the outcome of the meeting.
However, some analysts do not agree, Simon Simeonidis, Director and Research Analyst, Indiana University, stated the documents were “negative”.Simeonidids expected the new cardiovascular trial will be required before receiving approval.
Vivus in a statement notes Qnexa is a low dose of both drugs and its intended use for weight loss is also in combination with diet and exercise. The company is not in support of off-labeling for phentermine and topiramate.
Many experts have concerns of over the drug due to its laundry list of side effects if taken for an extended period of time. For topiramate it creates feelings of mental fogginess, lack of concentration and memory lapses. Phentermine leads to a range of cardiovascular side effects such as heart attack and high blood pressure.
Dr. David Katz, co-founder of Yale University Prevention Research Center had noted that those side effects are the very issues 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 caused fatal blood pressure and heart valve problems in patients.
Xenical is the only long term use weight loss drug that is approved. Safety and effectiveness has not been established past two years. It is sold over-the-counter as Alli approved in 2007 as OTC. Last April it was noted that Alli has an accumulating risk of side effects.
Green tea fat burner has had its share of weight loss news but not in a bad light. These green tea supplements burn the fatty acids in our body without increasing heart rate, helps to prevent fatty liver disease, heart failures and enhances the body's metabolism.
Penn State University researchers last year that it may also help stop the extra pounds adding on by limiting how much body fat is absorbed into the body.
Green tea has diuretic properties so it does suggest you increase your water consumption. Urine increase maybe noticed due to the supplements helping your body toxins and water weight. Note that it should not be in excess. Just like other weight loss pills you need to follow a healthy diet and exercise.
If you are pregnant or nursing do not take this supplement.
If you have a history of liver, kidney or stomach problems you should limit the consumption and check with your practitioner before using.
Every so often take a break from the supplements. This will decrease the chance of caffeine dependency and flush your system.
When taking a break you still need to continue eating healthy and stay active.
Along with weight loss green tea gives additional benefits such as lower cholesterol, cancer prevention and fights bacteria and fungus.