US regulators approve new weight loss drug
By Kerry Sheridan, AFPWASHINGTON--U.S. regulators on Tuesday approved the second new anti-obesity drug in 13 years, Qsymia, for use with exercise and a good diet in people who are obese or overweight with certain medical problems.
July 19, 2012, 12:18 am TWN
Some analysts have touted Qsymia as the next “blockbuster,” akin to the best-selling cholesterol drug Lipitor, with the U.S. market desperate for new treatments for the two-thirds of the population that is overweight or obese.
But critics fear it carries side effects that could be dangerous, like speeding up heart rates and causing birth defects, and warranted further study before being approved for widespread use.
“Qsymia, used responsibly in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, provides another treatment option for chronic weight management in Americans,” said Janet Woodcock, director of the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research.
The drug, which was formerly known as Qnexa, is approved for use in people who are obese, meaning they have a body mass index of 30 or higher, or in people who are overweight and have at least one related condition like diabetes, high cholesterol or high blood pressure.
In two randomized, controlled trials of around 3,700 obese and overweight patients followed for one year, the highest doses of the drug were associated with an average weight loss of between 6.7 percent and 8.9 percent over a sugar pill.
“All patients received lifestyle modification that consisted of a reduced calorie diet and regular physical activity,” the FDA said.
Made by California-based Vivus Pharmaceuticals, Qsymia contains phentermine and topiramate, two drugs that are already on the market for aiding weight loss and preventing seizures.
Some doctors already prescribe the combination as an off-label use for helping patients manage their weight.
The FDA warned that Qsymia “must not be used during pregnancy because it can cause harm to a fetus,” as studies have shown an increased risk of babies being born with cleft palates when women taking the drug became pregnant.