WASHINGTON (AFP) - US regulators on Tuesday approved a new drug called Qsymia to boost weight loss in obese and overweight people — the second such drug to reach the US market in 13 years.
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. Qsymia contains phentermine and topiramate, two drugs that are already on the market for aiding weight loss and preventing seizures. 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 palate when women taking the drug .