A new prescription diet drug approved Tuesday by the government is expected to help heavy patients drop about 10% of their weight -- more than any other approved obesity drug.
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. Some experts are concerned that the drug raised 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 approving a diet drug.
Qsymia, from Vivus Inc. of Mountain View, Calif., is designed for people who are obese, or those who are overweight and have other weight-related health problems such as high blood pressure or type 2 diabetes. "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.
In late June, the FDA approved lorcaserin (Belviq) from Arena Pharmaceuticals. It helps people lose about 5% of their weight.
Qsymia will change the "landscape" for treatment of obesity, says W. Timothy Garvey of the University of Alabama-Birmingham, who studied Qsymia. But, he says, "this is not a magic pill. Patients can't take it and think that's all they have to do."
Qsymia is made up of the appetite suppressant phentermine and the anti-seizure medication topiramate, which is used to treat epilepsy and migraines.
Scientists say it will provide a range of medical benefits, including reducing blood pressure and risk of developing diabetes.
Others have raised safety concerns; it caused increased heart rate in some patients taking a high dose. Topiramate has been associated with an increased risk of oral clefts in the newborns of women who took it.
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 it increases heart rate, and four users 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.
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