FDA panel recommends new diet drug Qnexa

February 23, 2012|By Stacey Burling, Inquirer Staff Writer

For 10 years, Louis Aronne has been giving patients a combination of phentermine, a 50-year-old stimulant widely used to control appetite, and topiramate, a newer antiseizure drug, to help them lose weight.

The combination works, he said, and with fewer side effects than when the drugs are given alone.

"If it's used in appropriate patients and monitored judiciously, I think that a medicine like this can play an important role," said Aronne, who directs the weight-loss program at New York Presbyterian Weill Cornell Medical Center. "One of the biggest problems . . . is we don't have many options."

Story continues below.

An FDA advisory panel agreed Wednesday.

The drugs Aronne is already using, in a slightly different formula, are the components of Qnexa, a new and controversial diet drug that won the recommendation of the panel of experts by a 20-2 vote. The group also said the drug's safety should be monitored in a large study after its approval.

Most of the time, the FDA accepts such recommendations. It is expected to rule on the drug in April. In its recent decision on another diet medication, it required that the larger safety study be done before final approval.

If approved, Qnexa would be the first new diet drug in 13 years. In trials, it helped patients lose about 10 percent of their body weight. Even though that's not enough to make most overweight people thin, it's a strong showing for a diet medication. Losing even small amounts decreases the health risks associated with obesity.

The FDA had said it had concerns about potential side effects of the drug: heart problems and birth defects in the babies of women who take Qnexa while pregnant.

The federal agency rejected the drug in October 2010 but its maker, Vivus Inc. of Mountain View, Calif., asked for a chance to present new information.

The only drug now on the market for long-term weight loss is orlistat (brand names Xenical and Alli), which prevents the body from using 30 percent of fat consumed. That reduces the number of calories the body uses but produces some really unpleasant gastrointestinal problems if users keep eating fatty foods. Experts say it hasn't been popular.

Critics of Qnexa worry that America's obesity epidemic - a third of adults are obese - will create huge demand, potentially exposing millions to the side effects.

1 | 2 | Next »
|
|
|
|
|