The worldwide fight against obesity may have just gotten easier. The FDA approved two new weight-loss medicines: Qsymia and Belviq. Until recently, there was a 13-year stretch in which the FDA did not approve any new medications to help people struggling with obesity.
What is Qsymia?
Qsymia is a combination of the appetite suppressant phentermine (the safe half of the diet drug Fen-Phen) and the anti-seizure/migraine medication topiramate. It is manufactured by the pharmaceutical firm Vivus, Inc. and was formally known as Qnexa.
How does Qsymia work?
As I said, phentermine is an appetite suppressant. It is thought to trigger the release of the chemical norepinephrine in the brain, which increases blood concentrations of leptin, an appetite-regulating hormone.
Topiramate, commonly known as Topamax, is prescribed as an anticonvulsant and migraine medication. It can aid in weight loss by increasing the feeling of being full, making foods taste less appealing and increasing calorie expenditure.
As you can imagine, together these two drugs can pack a powerful punch against the battle of the bulge.
Who is Qsymia designed for?
The drug is approved only for adults who are obese (BMI of 30+) or overweight (BMI of 27+) and who also suffer from conditions such as hypertension, type 2 diabetes or high cholesterol.
It will be available in a standard dose, but also a higher dose for select patients. Women using Qsymia must consistently use an effective method of birth control. If a woman becomes pregnant while using Qsymia, they should discontinue the medication immediately and contact their physician.
Who should NOT use Qsymia?
Women who are pregnant, people with eye problems (especially glaucoma), people who have an overactive thyroid, people taking a type of antidepressant called MAOI, or people who are allergic to phentermine, topiramate, or any of the ingredients in Qsymia should NOT use the drug.
Mandated by the FDA, Qsymia will be packaged with a special Risk Evaluation and Mitigation Strategy (REMS), which includes an education guide for patients, providers and pharmacies.
How should Qsymia be used?
Qsymia is designed to be used in combination with a healthy lifestyle, including a reduced-calorie diet and exercise. In clinical trials, Qsymia was only effective when combined with this kind of lifestyle.
How long do you have to take Qsymia?
Once you begin this regimen, you will have to continue it for the rest of your life, unless you develop a side effect or another reason to discontinue usage.
What, if any, are the side effects?
The most common side effects are tingling in the hands and feet, dizziness, change in taste, trouble sleeping, constipation and dry mouth. Qsymia can also increase your resting heart rate, affect how you think and is associated with difficulties concentrating.
Topiramate can increase the risk of suicidal thoughts or behavior, initiate new or worsening depression, or cause other mood/behavior changes in some patients. Be aware of such changes and call your health care provider immediately if you experience any of these symptoms.
If you have type 2 diabetes, weight loss may increase the risk of low blood sugar. Speak with your physician about this, because he or she might have to adjust your diabetes medications.
What have clinical trials shown?
Last year, a study funded by Vivus, Inc. found that obese patients taking Qsymia lost an average of 22 pounds over a year, while also lowering their blood pressure and cholesterol levels. In a placebo-controlled clinical trial, those who took Qsymia lost an average of 8.9 percent versus those taking the placebo. Seventy percent of those taking Qsymia lost at least 5 percent of their body weight compared to only 20 percent of those on the placebo.
Didn’t I read that Qsymia was not approved by the FDA a few years ago?
Qsymia was initially denied FDA approval in 2010 because of potential side effects, including heart palpitations and birth defects if taken by pregnant women (such as cleft lip or palate). After the current approval process, Vivus agreed to conduct further testing to show that Qsymia does not have dangerous cardiovascular side effects. Clinical trials have already shown that Qsymia can lower blood pressure, reducing the risk of heart attack and stroke.
When will Qsymia be available for use?
Right now, it’s expected to become available in September, but will only be sold through certified pharmacies -- not your local, family-owned pharmacy.
The overall consensus is that the best way to keep off unwanted weight is through a healthy lifestyle, including proper nutrition and exercise. Qsymia offers benefits to some of the estimated two-thirds of obese or overweight Americans who aren’t losing weight with lifestyle changes alone.
Qsymia can act as the jumpstart that many people need to get on the road to weight loss. As always, speak with your doctor before beginning any diet or exercise regimen.
Dr. David B. Samadi is the Chairman of the Department of Urology and Chief of Robotic Surgery at Lenox Hill Hospital in New York City. He is a board-certified urologist, specializing in the diagnosis and treatment of urological disease, with a focus on robotic prostate cancer treatments. Dr. Samadi joined Fox News Channel in 2009 as a medical contributor. To learn more please visit his websites RoboticOncology.com and SMART-surgery.com. Find Dr. Samadi on Facebook.