The second new weight loss drug in only one month has been approved by the U.S. Food and Drug Administration. The diet drug, Qsymia, represents the FDA’s new move that offers doctors and patients more ways to combat excessive weight gain and obesity as this problem becomes more prevalent throughout the world.
The Voting Process and Approval
In February, the advisory panel voted overwhelmingly in favor of the drug, which was the first time the FDA has approved a weight loss drug since orlistat over 10 years ago. The drug was originally named Qnexa, although the FDA required the manufacturer, Vivus, to rename it to prevent consumer confusion as it sounds like other drugs on the market. The recommendation of the committee and the approval this week came with both criticism and praise. Some are concerned with the side effects of the drug, while others feel it’s a great benefit to patients to have more options for weight loss besides diet, exercise and surgery.
On the side of critics is Dr. Gerald Mullin from the John Hopkins School of Medicine. Dr. Mullin believes that, while the drug will help with weight loss for some people, it will also perpetuate the “magic bullet” approach to losing weight without addressing the underlying problem. Meanwhile, Dr. Lavie at the New Orleans Ochsner Medical Center believes it has a great deal of potential to help patients overcome obesity.
With nearly 1 in 3 people in the United States classified as obese, there has been a lot of frustration over the very limited options for both doctors and patients. Until now, doctors are usually left recommending only diet and exercise, with bariatric surgery a last resort for those obese enough to qualify.
There has also been a lot of research released recently showing that obesity may be aggravated by mechanisms in the brain that regulate weight, which makes it hard for people to lose and then maintain weight loss. New drugs like Qsymia may improve the chances of successful weight loss for these individuals without attaching the blame and stigma that has been so common.
What is Qsymia Exactly?
So what is Qsymia? It’s actually a combination of two drugs already approved by the FDA: topiramate, which is a drug used to treat epilepsy and migraines that has weight loss effects and phentermine, a stimulant appetite suppressant. According to the manufacturer, Qsymia is meant to be used with exercise and a proper diet.
There are side effects of the drug, however, and it was initially turned down by the FDA in 2010 because of concerns over the chance of birth defects, cognitive effects and heart problems for patients on the drug. Qsymia was only approved this year with the agreement that the Vivus will provide a great deal of information to doctors about the potential risks of the weight loss drug and ways to manage them. It’s these side effects that actually have some doctors worried, especially considering the history of other diet drugs like fen-phen, which was initially approved by the FDA and then withdrawn over these same concerns.
The drug is currently approved for adults with a BMI of 30 or higher, or those with a BMI of 27 or higher with one or more weight-related conditions like type 2 diabetes, high cholesterol or high blood pressure. Because the drug may harm a fetus, it cannot be taken during pregnancy. One component of the drug, topiramate, can cause a higher risk of oral clefts when taken during the first trimester. It’s also recommended that women capable of reproducing have a negative pregnancy test before beginning the drug and every month while using Qsymia.
The Trial Lead Towards Success
Qsymia was tested in 2 random, placebo-controlled trials with over 3,700 overweight and obese patients, both with and without serious weight-related conditions like type 2 diabetes. The trail lasted for 12 months and all patients underwent lifestyle changes including a lower calorie diet and exercise.
Results from the 2 trials showed that those taking the recommended dose lost an average of 6.7% of their body weight over those treated with the placebo, while those taking the highest daily dose lost 8.9% of their body weight over the placebo. 62% of patients on the recommended dose lost at least 5% of their body weight while 69% of those taking the highest dose lost at least 5%. Only 20% of the patients in the trials taking the placebo lost over 5% of their initial body weight.
The recommended dose of the drug has 7.5 milligrams of phentermine with 46 milligrams of the topiramate. Some patients may also qualify for the higher daily dose with 15 mg of phentermine and 92 mg of topiramate.
The study also found that individuals who didn’t lose at least 3% of their initial body weight by the 12th week of treatment were not likely to achieve successful weight loss with the continued dosage. It’s recommended that patients be evaluated by the 12th week to look at their weight loss and determine if they should discontinue the drug or switch to the higher dose. It’s also recommended that patients discontinue Qsymia if they have not lost at least 5% of their body weight by the 12th week while taking the higher dose.
Who should not take Qsymia?
Certain patients should not be prescribed Qsymia, including those with hyperthyroidism and glaucoma. Because the drug may increase heart rate, it’s not advised for those at a high risk for stroke or heart attack. Those with unstable heart disease or a recent stroke within the last six months should also not take Qsymia. All patients beginning treatment with this drug should undergo regular heart rate monitoring.
Along with the Medication Guide to advise patients and doctors about the risks of the drug, Vivus must also conduct ten post-marketing studies with a long-term cardiovascular trial to determine Qsymia’s risk of cardiac events like heart attack.
Although these are the most serious potential side effects of the drug, more common side effects include insomnia, constipation, dry mouth, dizziness, a change in taste sensation and paresthesia, or a tingling sensation in the feet and hands.