After a 13-year dry spell, the Federal Food and Drug Administration (FDA) has approved two new weight-loss pills in less than a month. Are either of these new pills a magic bullet for dieters—or even a helpful weapon to add to their fat-fighting arsenal?
The latest FDA-approved pill is called Qsymia, a mix of the appetite-suppressing phentermine (not to be confused with Fenfluramine, a now-illegal ingredient in the infamous weight-loss drug known as fen-phen) and topiramate, an anticonvulsant. While Qsymia was officially approved on Tuesday, this drug combination has been prescribed off-label for years, says Stephen Gullo, Ph.D., president of the Institute for Health and Weight Sciences in New York City. Still, Qsymia, which was formerly known as Qnexa, is meant for a very specific type of patient and could have serious side effects. (Read our take on the first drug, Belviq, here.)
How does Qsymia work?
Phentermine is a well-known appetite suppressant that’s used for short-term weight loss. Topiramate (an anti-seizure medication) makes people feel fuller after eating. Doses are determined by a person’s Body Mass Index (BMI) and change over the course of treatment.
In two year-long studies with approximately 3,700 total obese and overweight participants, patients had an average weight loss of 6.7 to 8.9 percent over placebo groups. In addition, approximately 62 to 69 percent of patients lost at least five percent of their body weight, compared with about 20 percent of patients treated with placebo.
Qsymia, like its recent predecessor Belviq, requires a lifelong commitment. “People in this weight category have a chronic problem and therefore, they need a chronic solution,” says Dr. Gullo. In other words, the pills may help people lose weight but there are no promises the weight loss will stick once someone goes off the drugs.
Who should take Qsymia?
Qysmia is meant for obese people (BMI of 30 or greater), or overweight people (BMI of 27 or greater) with at least one weight-related health problem, like high blood pressure, type 2 diabetes, or high cholesterol. Calculate your BMI here. (Learn more about how your BMI can affect your health.)
People with hyperthyroidism or heart problems are advised against taking Qsymia because it can cause an increase in heart rate. Pregnant women are also steered away from the drug because of the risk of birth defects, including cleft palate. Women who choose to take the medication must first take a pregnancy test. They’re also expected to use contraception and to take monthly pregnancy tests just to be safe.
When will Qsymia be available?
Vivus, the makers of Qsymia, say the drug will be available before the end of 2012. However, it will only be available by mail through specially certified pharmacies.
Even once it’s on the market, more studies of Qsymia will be conducted to determine its long-term risks, particularly its potential effects on heart health. “I would wait a year or two to see if there were any reported significant effects,” says Dr. Gullo.
Which diet pill is the best, Qsymia or Belviq?
Experts are split on this one. Dr. Gullo is partial to Qsymia (over Belviq) because its ingredients have been used together (off-label) for weight loss for many years. Other experts are concerned about Qsymia’s possible risks, especially heart problems and birth defects. But Belviq has risks too, including a potential for dependence.
Dr. Gullo recommends that people who take either pill see their doctor often. He also emphasizes that taking these pills is not an excuse to eat poorly. People prescribed these medications should follow a weight-loss focused diet (about 1200 calories a day) and exercise regularly (about 30 minutes, 3 to 4 times a week).
Unfortunately, for those who hoped the Fat-Melting Fairy had arrived in the form of these new weight-loss pills, Dr. Gullo brings us back to reality. “I don’t think the cure for obesity will be magically found in either of these drugs,” he says.
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photo: Vivus, Inc.
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