An FDA advisory panel is recommending approval of the first new prescription weight loss drug in more than decade.
Some of the clinical trials for Qnexa were conducted in Miami-Dade several years ago. Clinical Research of South Florida in Coral Gables was one of the study sites.
Dr. Jeffrey Rosen was involved in that research and was impressed with the results. However, he was frustrated by the lack of approval by the Food and Drug Administration. An advisory panel had previously rejected Qnexa.
"I said to myself, this isn't fair to my patients. If I have patients who are going to benefit from this drug or this combination, I have to offer it to them," Rosen said.
Qnexa is a combination of two drugs that have each been approved by the FDA for certain indications. Phenteramine is approved for short-term weight loss. Topiramate is used to prevent seizures and migraines. When prescribed for other uses that's called off-label use.
"Doctors can use any medication off-label as long as they feel it's in the best interest of the patient," Rosen explained.
A year and a half ago he started prescribing the two drugs for weight loss to patients who are either obese or are overweight and have medical conditions.
Ira Shapiro was the first of his patients to use that drug combo off-label. He has lost 70 pounds and his blood sugar is back to normal levels.
"I'm not hungry, I feel satiated, and eat less," he said.
Rosen now has a couple hundred patients taking the two medications for weight loss, and said most of them have responded well.
There have been concerns about heart complications.
"I have not had any significant complications or side effects. Of course I've used it on very few patients. A couple of hundred patients is not a lot,” Rosen said.
Shapiro is now taking lower doses of a cholesterol-lowering drug and is completely off his blood pressure medication. He is experiencing some insomnia, but not enough to stop the medication.