Arlene Frankel works at Cleveland Clinic Florida, where she had weight loss surgery in August. Since then, Frankel has lost 90 pounds and dropped several sizes.
Frankel said she is now a “6 or 8 depending. And before surgery I was a 20, 22.”
While she’s thrilled with the results, Frankel wishes a simple pill for obesity were available.
“Oh, definitely that would have been easier," she said.
Next week, the pill Qnexa will be reconsidered by advisors to the Food and Drug Administration. It’s a combination of two drugs that individually are FDA-approved.
“One which is an anticonvulsant and the other one which is an amphetamine. The one will create satiety, the anti-convulsant will make the patient feel full, (while) the other is going to take away the appetite from the patient,” said Dr. Raul Rosenthal. He is chairman of the Bariatric and Metabollic Institute at Cleveland Clinic.
The FDA previously rejected Qnexa because of safety concerns including risk of birth defects if a woman becomes pregnant while taking it, heart problems, depression and memory loss. The manufacturer will be presenting new information to an FDA advisory committee on Wednesday.
Bariatric surgery has the highest success rate for weight loss and reversing diabetes when diet and exercise have failed. However, surgeons like Rosenthal say safe and effective medications are needed to deal with the overwhelming problem of obesity.
“Either you go to the gym and you do a diet or you come to us and do surgery. There has to be a middle point because we cannot operate on tw- thirds of America to get them to lose and keep the weight down,” Rosenthal said.
Since Qnexa is not on the market, some doctors are getting around that by prescribing the two drugs that are in it. That’s called "off-label use."
The New York Times is reporting that the FDA released documents today showing the agency still has safety concerns about the drug.