A new prescription diet drug OK'd Tuesday by the government is expected to help heavy patients drop about 10% of their weight - more than any other approved obesity medication.
Qsymia (pronounced kyoo-sim-ee-uh), which suppresses appetite and increases the feeling of fullness, boosts patients' weight loss when used along with a diet and exercise plan. Until now, the drug had been called Qnexa. Some experts are concerned that the drug raised the heart rates slightly in some patients.
This is the second medication to fight obesity that the Food and Drug Administration has approved this summer after going for more than a decade without OK'ing a diet drug.
Qsymia from Vivus Inc. of Mountain View, Calif., is designed for people who are obese, which is roughly 30 or more pounds over a healthy weight, or those who are overweight and have other weight-related health issues such as high blood pressure, type 2 diabetes or high cholesterol. "It's not for patients who want to lose a few pounds," says Peter Tam, president of Vivus.
It will be available to consumers by the fourth quarter of this year, Tam says. The price is not being released yet, but it won't be "outrageous," he says. Insurance companies probably will not cover the cost of the medication initially, he says.
Qsymia is the first obesity medication approved by the FDA "to demonstrate double-digit weight loss in those taking mid-to-high doses," Tam says.
In late June, the FDA approved lorcaserin, to be sold as Belviq (pronounced bel-veek) from Arena Pharmaceuticals. It helps people lose about 5% or more of their starting weight and is used in combination with a healthy diet and exercise. Lorcaserin is expected to be available to patients in the first quarter of next year.
Qsymia will change the "landscape" for the treatment of obesity, says W. Timothy Garvey, chair of the department of nutrition sciences at the University of Alabama-Birmingham, who studied Qsymia. But he cautions, "This is not a magic pill. Patients can't take it and think that's all they have to do. It needs to be used with a lifestyle modification program."
Thomas Wadden, director of the Center for Weight and Eating Disorders at the University of Pennsylvania's Perelman School of Medicine, agrees. "There's no free lunch. Many dieters will have to pay for Qsymia out of pocket and, to obtain their best results, they'll need to work at changing their eating and activity habits. Dieters should expect as much from themselves as they do from medications."
Qsymia is made up of two older medications: the appetite-suppressant phentermine and the anti-seizure medication topiramate, which is used to treat epilepsy and migraines.
Some doctors have been prescribing the two drugs together for weight loss in what's called an off-label use, which is the practice of prescribing medications for an unapproved indication.
Scientists who have researched Qsymia say it will provide a range of medical benefits for patients, including reducing blood pressure and the risk of developing diabetes.
"Its strength is not just the weight loss, but the large improvements in blood pressure, fasting blood sugar and other measures of health risk," says Tim Church, director of preventive medicine research at the Pennington Biomedical Research Center in Baton Rouge and an adviser to Vivus.
Others have raised concerns about safety; it caused an increased heart rate (about 1.6 beats a minute) in some patients taking a high dose. One of Qsymia's ingredient's, topiramate, has been associated with an increased risk of oral clefts in the newborns of expectant mothers who took topiramate.
Sidney Wolfe, director of the health research group at Public Citizen, a consumer group, says it was "reckless" of the FDA to approve Qsymia. He says research shows the medication increases heart rate, and four patients on the diet pill had non-fatal heart attacks during the research, while none of those on the placebo had heart attacks.
"It's either magical or delusional thinking to believe that a drug will turn off hunger without hitting other targets where it will do harm, which is usually the cardiovascular system," Wolfe says.
He points out that several previous diet drugs have been withdrawn from the market because they increased cardiovascular risk. "Doctors and patients are desperate for a quick fix. They are desperate to the point where they are willing to risk patients' lives," he says.
Garvey says the medication increases heart rate by an average of one to two beats per minute for some patients, but the other positive effects on the cardiovascular system, including a "pronounced decrease in blood pressure," contribute to an overall reduction in risks for cardiovascular disease and diabetes.
Vivus has begun planning a large post-marketing drug trial to investigate cardiovascular outcomes and possible improvements in longevity, Tam says. The trial should be finished in four to five years, he says.
Tam says obesity is a chronic medical condition, but it's unclear if all patients will need to stay on the medication after the weight loss to keep off the extra pounds. Some may be able to maintain a lower weight on their own; others may need to continue taking the medication.
He says women of child-bearing age will be told they must use contraception when taking Qsymia. During the drug's trials, there were no cases of oral clefts in the newborns of pregnant women who took Qsymia. However, there is an increased risk for the newborns of pregnant women who take topiramate, one of the ingredients of the diet drug. "We believe it's important to be vigilant and educate physicians and patients about this potential risk," Tam says.
About 36% of adults in this country are obese. About 42% of adults are projected to be obese by 2030 if something isn't done to reverse the trend.
"We still have a very long way to go in treating obesity seriously, but these two drug approvals (Qsymia and Belviq) start our journey with several promising steps," says Patrick O'Neil, president of the Obesity Society, a group of weight-control researchers.
By Nanci Hellmich