New weight loss drug set for FDA approval - wave3.com-Louisville News, Weather & Sports

New weight loss drug set for FDA approval

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LOUISVILLE, KY (WAVE)- It's not a 'magic' pill, but for people needing to drop some serious weight it may be just what the doctor ordered. And soon, doctors across the country are expected to start prescribing a new weight loss drug called Qnexa.  

At Body Allure in Louisville, patients can already get the drug. Doctors Steve and Mike Samuel have been getting the drug from a compounding pharmacy for over 2 years. Patients using it along with the Wellness Program at Body Allure are dropping 10% to 20% of their bodyweight.  

Qnexa is billed as the first new weapon to combat obesity in overs 12 years. It's a combination of two older drugs, phentermine, used for short term weight loss since the 50's and topiramate, also known as Topamax.

"The FDA (advisory committee) in their meeting in February voted 20 to 2 to approve this drug" Dr. Steve Samuel said, "they had 3 huge studies they did before they voted on this drug."

The vote sets the stage for what many believe will be an FDA approval on July 17th. But in the clinical trials, some side effects were found that do raise concern including heart palpitations, increased heart rate.

Dr. Samuel says that's typical, "within 3 to 5 days, those go away" he said, and if they don't he would take the patient off the drug. He prescribes Qnexa off label, before approval without hesitation for most patients.  

"Heart problems aren't an issue" he said, "high blood pressure is. Okay, phentermine can raise your blood pressure.  Another great reason to go to a place that has doctors like us, because we see you on a regular basis and take your blood pressure and your pulse."

Patients in the Body Allure Wellness Program are followed with medical checkups every two weeks.

"I was initially hesitant" said John Cowley, also a doctor. He decided to try Qnexa despite concerns over his own blood pressure. With the combined diet and exercise "that first month" he said "was unbelievable. Now it was a very strict diet, I was exercising, on medication and I lost 25 pounds."

As his weight dropped, so did his blood pressure. Other patients are reversing diabetes, improving heart and joint function.

"When you talk about one out of every 3 Americans in 2012 being obese and 9 cents of every dollar in healthcare being spent on obese people, that's 150 billion a year" Dr. Samuel said. It's why drug companies are searching for a 'magic' pill and some believe Qnexa is the first step.

While critics point to the risks, and all the weight loss drugs before that have either failed or caused serious, even deadly outcomes, the FDA will soon decide if the benefits of Qnexa outweighs whatever potential risks have been found so far.

"What the FDA said was, we will approve any drug that causes a 5% weight loss" Dr. Samuel said, "and what they found on the 3 studies with Qnexa was 10%."

This is the 2nd time the FDA's looked at this drug, it first said no. Topamax is linked to birth defects and phentamine was part of the fen-phen combo that caused heart damage and was yanked in the 90's. Dr. Samuel says this drug is completely different. It's a low dose of phentamine and it's a controlled release formula so it doesn't dump all at once into the system. Again, the FDA is scheduled to vote July 17th.

To get Qnexa through Body Allure, you must enroll in the Wellness Program. It's a 12 week personalized program that focuses on diet, fitness, wellness supplements and diet aids like Qnexa. It's $599 for the 12 week program. Qnexa is an additional cost of $50 a month.

Dr. Samuel says some insurance is already covering the cost of Qnexa for patients.

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