Beckley, Bluefield & Lewisburg News, Weather, SportsFDA Debates Approval of New Diet Drug

FDA Debates Approval of New Diet Drug

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By Randall Pinkston

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NEW YORK -

A Food and Drug Administration panel is reconsidering whether to approve the diet pill Q-nexa.

The advisers rejected the drug in 2010 because of the potential side effects.   Now they're taking a closer look.

Mariel Rosenwasser tried every diet but just could not lose weight.

"I was doing the wrong thing because why wasn't the weight coming off?" said Mariel Rosenwasser.

She weighed more than 200 pounds when her doctor put her on a combination of two drugs; an appetite suppressant phentermine and the drug Toprimate which is supposed to make patients feel full.

"Within the first year, I lost over 50 pounds," said Mariel Rosenwasser.

A Food and Drug Administration panel is considering whether to recommend a new diet pill called QNexa which combines the two drugs.  A study found obese patients taking QNexa lost an average 10 percent of their body mass.

But the FDA rejected the drug in 2010, concerned about potential side effects including heart problems and birth defects.

At Wednesday's hearings, the makers of QNexa presented encouraging new findings about the drug's safety.

"One of the outcomes of the study performed on thousands of patients is that all of the cardiometabolic risk factors seem to improve," said Dr. Louis Aronne, with NY Presbyterian Hospital.

More than one out of every three adults in the U.S. is obese but currently there's only one FDA approved drug for weight loss.

The FDA has not approved a diet drug since Xenical, more than a decade ago.

Mariel Rosenwasser says people like her need more options.

"There are these two medications that work so well for me, would be amazing for people to have access to these two medications, to feel that there is hope to go on and live a healthier life." Rosenwasser said.

She says the combo not only helped her lose weight, but helped her keep it off.

The FDA panel's recommendation is not binding.

The FDA is expected to make its final decision in April.