There is a whiff of science fiction about it: two thirds of a population seems to be slowly, inexorably destroying itself. A substance comes along that stops the self-destructive behavior. However, the chemical can’t be given to women of reproductive age because of birth defects associated with it, so it will be kept under lock and key.
No, it’s not a screenplay or a scene from a dark Margaret Atwood novel. It’s the newest weight-loss medication, Qnexa. This drug got the green light from a Food and Drug Administration (FDA) advisory panel on Feb. 22, a crucial step toward approval of the drug, which is expected in April. Previously, In 2010, an FDA advisory panel nixed Qnexa, citing concerns about cardiovascular risks and birth defects associated with the drug.
With one-third of Americans obese and one-third overweight, the panel this time deemed that the benefits of Qnexa outweigh its risks. Obesity poses serious health risks, and the thinking behind the medication is that diet and lifestyle aren’t sufficient to address the problem in many people. The FDA is not required to take the advice of the panel in its final decision about the drug, but the agency generally abides by the recommendations of the advisory group.
Studies on Qnexa show that people who took the drug averaged a 10 percent loss in body weight over two years. But the results come with a price—escalated heart rate and greater likelihood of birth defects. Qnexa ups the risk of cleft lip and cleft palate significantly. It will not be prescribed to pregnant women, and women of childbearing age who take the drug will undergo monthly pregnancy tests. The drug manufacturer, Vivus, of Mountain View, Calif., pledged to put safeguards in place to monitor the drug’s use and to ensure that pregnant women do not take it.
These safeguards include training for health care providers who prescribe the drug and limited access to the drug through only a few select mail-order pharmacies. The promise of these safeguards factored into the panel’s decision to OK Qnexa this time. Vivus will also conduct additional clinical trials on Qnexa, but not until after it is approved.
Qnexa is a combination of phentermine, which suppresses appetite, and topiramate, which is used to treat epilepsy. Both phentermine and topiramate are available as individual drugs, but Qnexa combines them in extended-release form and at lower dosages.
When it becomes available, Qnexa will join the only other weight-loss drug on the market, Xenical, which inhibits the body from absorbing fat. The side effects of Xenical, delicately referred to as “change in bowel habits,” proved too embarrassing and troublesome for many people who tried the drug after it was approved in 1999.
Some hail the potential addition of Qnexa to the weight-loss armament as a positive development for people who struggle to lose weight with other methods. Skeptics worry about the side effects, which can also include memory loss and difficulty concentrating, and about the fact that some people quickly regain the weight they lost when they stop taking the medication.
Drugs like phentermine that suppress your appetite will spur weight loss, but cause people to lose muscle, which cuts the ability to burn calories, notes Susan Sklar, M.D., founder and medical director of the Sklar Center in Long Beach. “When you lose muscle, you lose your calorie-burning capacity.” The loss of adequate muscle to burn calories efficiently puts people on a path where they can only eat increasingly smaller amounts of food a day to try to maintain their weight, Sklar says. “They will go from 1,500 calories, to 1,200 calories, to 1,000 calories, which isn’t a lot of food. That’s why you hear people say, ‘I can’t even look at food without gaining weight.’”
She also observes that topiramate, the anticonvulsant contained in Qnexa, interferes with memory and mental function. The brand name of topiramate is Topamax. The memory loss some people experience with Topamax has led to its nickname, “Dopamax,” Sklar says.
Long Beach personal trainer Kelle Erwin says the lure of a quick fix with a weight-loss pill may be tempting, but moving the needle down on the scale has no benefit if there are other health costs. “The idea that you would take something that potentially damages your body to lose weight makes no sense to me,” she says. Erwin, who is also trained as an emergency medical technician (EMT), says she helps her clients make one change at a time in their diet and exercise patterns, so that they don’t become overwhelmed and give up. “The outcomes are slower, but they are more permanent.”
The long-term results and effects of Qnexa will not be revealed until after the drug is approved and more people have taken it. The enormous spike in Vivus stock after the FDA panel approval suggests that sales of the drug are expected to be brisk.
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