FDA approves second weight-loss drug since June

Food and Drug Administration approved a second weight-loss medication in as many months.

FDA’s decision on July 17 to allow the use of Qsymia (which previously was known as Qnexa) comes less than a month after it approved Belviq, which was the first weight-loss drug to be approved in 13 years.

Qsymia was approved for use in overweight individuals and obese individuals who have at least one weight-related condition, including diabetes, high blood pressure and a high cholesterol level. Overweight individuals are people who have a body mass index (BMI) of 27 or greater. Obese individuals are those who have a BMI of 30 or greater. (Body mass index is a measure of body fat based on an individual’s height and weight.)

In 2010, an FDA panel rejected the medication that now is called Qsymia, because potential cardiovascular risks and birth defects were linked to the medication. But another FDA panel cleared the medication for FDA approval in February 2012.

FDA says women who are pregnant shouldn’t take Qsymia, because one of the active ingredients, topiramate, can cause birth defects. The agency also says individuals who have had a recent heart attack or a stroke shouldn’t begin to use Qsymia until 6 months after their incident.

Qsymia’s manufacturer, Vivus, also will be required to conduct 10 studies that focus on the drug’s long-term cardiovascular effects.

As we reported in June 2012, some health experts aren’t convinced that that the potential benefits of Belviq and Qsymia outweigh their risks. Furthermore, experts believe that FDA’s approval of both drugs indicate how desperate the medical community is to find ways to curb the growing obesity crisis.

Qsymia was among the medications that Consumers Digest scrutinized in “The Real Dangers of Weight-Loss Drugs” in its May/June 2011 issue.

– K. Fanuko