"Tammy Wade knew she had to try something else to lose weight when she stepped on the scale and saw the number  pounds. Wade  of McCalla Ala. is only  feet  inches tall. She had tried everything. Nothing worked. I had problems with my feet and ankles and they were saying I was borderline diabetic Wade says. Im like well I gotta do something you know. So I needed really did need to lose the weight. So Wade volunteered to help test Qnexa http an experimental drug pending before the Food and Drug Administration. She quickly noticed a big difference. I didnt feel ravenous and I didnt want to snack all day long she says. Over the next year Qnexa  http Wade slowly drop about  pounds and keep it off for another year. It makes you feel so much better Wade says. Your back dont hurt your feet dont hurt. But the FDA rejected Qnexa http in  because of concerns about side effects especially possible heart problems and birth defects. Article continues after this message from our sponsor FDA Briefing Documents Released Update Feb.   a.m. The FDA posted a page review of the possible risks and benefits of Qnexa on the agencys website http The review noted continued concerns that Qnexa can increase the risk for several possible side effects including increased heart rate birth defects and thinking problems such as memory lapses and confusion. But the agency also noted Qnexa does appear to help many people lose at  percent of their body weight In addition it was somewhat reassuring that the drug also appears to produce some health benefits beyond weight loss including lower blood pressure. Among the questions the agency plans to ask an advisory committee meeting Feb.  to review the drug is whether Vivus Inc. which makes Qnexa should conduct a study better assessing the drugs affect on the heart before the drug is approved. In its own page review Vivus called Qnexa a significant advancement in the medical treatment of obesity and detailed the potential benefits of the drug. The company also outlined a plan to minimize the chances that women of childbearing age would take it. Qnexas rejection came amid a flurry of failed attempts by drug companies to win approvals of new weightloss drugs. The setbacks put a spotlight on how the FDA handles these drugs. Even though obesity is at epidemic levels the FDA hasnt approved any new weightloss medicines since . We have twothirds of all Americans who are overweight or obese and the costs are nearing  billion a year says Christine Ferguson http a health policy professor at George Washington University. The sheer magnitude of the problem really requires us to address it more aggressively and thoughtfully than we have. Ferguson has been helping to organize a series of meetings involving public health experts antiobesity advocates government officials and others to try to figure out what the FDA should do. We actually have this huge gap says Joe Nadglowski http of the Obesity Action Coalition who has been participating in the meetings. We go from Weight Watchers to bariatric surgery. And the fact that there isnt ... medical treatments for obesity including pharmaceuticals really is a challenge considering how big the problem is in this country. Part of whats going on is that the FDA has gotten a lot more cautious about approving new drugs in general after some serious drugsafety problems such as heart problems linked to the painkiller Vioxx. The FDA has been especially tough on weightloss drugs because of previous problems with those drugs such as the diet drug cocktail fenphen. Theres been a long history with obesity drugs that weve had to take off the market. You recall the fenphen episode where a significant number of people got heartvalve defects says Janet Woodcock http a top FDA official. Woodcock argues that the agency has to be extracareful with weightloss drugs because chances are it wont just be obese people taking them. When youre talking about a drug where it could go into literally tens of millions of Americans there has to be attention to safety Woodcock says. What might look like a rare problem now could turn into another public health disaster she says. But some say the agencys aversion to accepting any risks is outdated. They say the FDA wrongly still tends to view weightloss drugs as diet pills  something frivolous and used primarily for cosmetic purposes. We are not talking about medications to help someone lose five pounds to fit into their prom dress or wedding dress. Were talking about medications to help those who are struggling with the health impact of obesity Nadglowski says. So Nadglowski and others are pushing the FDA to take into consideration whether the risks of new drugs may be outweighed by their benefits beyond weight loss such as reducing the risk for heart disease diabetes and other complications of obesity. Woodcock says officials realize they may have to think about things differently. As the FDA works through this many are watching how the agency handles Qnexa. An FDA advisory panel is scheduled to review Qnexa again on Feb. . Barbara Troupin of Vivus http the company that is developing Qnexa says the drug appears to do a lot more than just help people lose weight. We see decreases in blood pressure. We see decreased rates of progression to diabetes. We see improvements in sleep apnea. We see improvements in quality of life. Pretty much all of our data shows significant benefits she says. Vivus hopes the FDA will agree that those benefits will outweigh some of the risks including the concerns about birth defects. The company is submitting new data it says show that the risk is lower than had been feared. Vivus also has a plan to minimize the chances that pregnant women will take it. Some see Qnexa as a test of the FDA trying to recalibrate how it weighs risks and benefits for weightloss drugs. For her part Wade just wants to be able to start taking it again. Shes gained back half of the weight she lost. I need to lose  more pounds again she says. And I need the help."