The Food and Drug Administration (FDA) gave approval for Qsymia in 2012. It was the second new diet drug approved within a month, and the most effective drug for weight-loss that the agency had given consideration to in years.
Qsymia, manufactured by Vivus Inc. received approval right on the heels of Arena’s Belviq, the diet pill that was cleared by the FDA in late June of the same year. Prior to approval of these two drugs, the last prescription weight-loss drug to be approved was Roche’s Xenical 13 years earlier, in 1999.
Diet pills have a mottled history with the FDA, in large part because of heart safety issues that have plagued previous diet drugs, most notably fenfluramine. It became very popular in a short amount of time while marketed as Fen-Phen, until it was withdrawn from the market after being linked to heart defects. New diet drugs have had a difficult path to approval ever since.
Who Should Use Qsymia?
The drug has been approved for use with obese adults with a body mass index (BMI) of 30 or greater. If the patient has at least one obesity-related condition, such as Type 2 Diabetes, high blood pressure, or high cholesterol, then overweight adults with BMIs of 27 or greater can also use the drug.
How Does Qsymia Work?
Qsymia combines two previously existing drugs: topiramate, an anti-seizure drug that has the added benefit of making people feel fuller when eating, and phentermine, an appetite-suppressing drug that has a long history of use as a short-term weight loss aid. Prior to Qsymia, some doctors had already begun to prescribe the two drugs together to promote weight loss. According to researchers, Qsymia’s success stems from how it targets multiple pathways in the brain that trigger overeating.
How Much Weight Loss Can You Expect?
It will vary from person to person. In clinical trials, obese and overweight patients that took Qsymia for a full year lost varying amounts of weight. On average, patients taking a mid-range dose lost approximately 8.4% of their total body weight. Patients receiving a higher dose averaged a loss of 10.6%.
Most of the weight loss came during the first three months, so it’s advisable for doctors to verify that the drug is working at that point. The FDA has noted that people that don’t lose at least 3% of their body weight within three months should discontinue use of the drug or try a higher dose, as they are unlikely to lose any significant weight without changes. If patients don’t lose at least 5% of other body weight after increasing to a higher dose, they should discontinue using Qsymia.
Qsymia just like Phen375 is designed to be used alongside traditional weight-management strategies, such as improved diet and moderate exercise. It is not a magic pill. Patients should not take it with the idea that they won’t have to do anything else. It needs to be a part of a lifestyle modification plan.
Recommended Reading: PhenQ and Weight Management
Can Qsymia Be Used to Drop a Few Pounds?
Doctors emphasize that Qsymia should not be used for cosmetic weight loss due to the potential risks of the drug. It’s not advisable for patients that only have a few pounds to use to use the drug. Doctors and pharmacists are educated about the potential risks of Qsymia, and they are able to pass that information along to their patients.
What Are the Health Risks of Using Qsymia?
There is the potential of developing heart issues, and birth defects when used by pregnant women. Some trial research has identified an increase in heart rate in patients, and a condition referred to as metabolic acidosis, which potentially leads to anorexia, fatigue, and hyperventilation. One ingredient in Qsymia, topiramate, has been linked to birth defects including cleft palate and cleft lip, when taken during pregnancy.
The FDA originally rejected Qsymia in 2010 due to safety concerns, but after Vivus and the FDA put strategies into place to reduce the risk, it was able to be approved. Some of these strategies include the requirement that women of child-bearing age must test negative for pregnancy prior to being prescribed Qsymia, and take a pregnancy test monthly while on the drug. Concerns about the drug’s safety remain, because in at least one Vivus trial, 34 women became pregnant even though they received instruction to use contraception.
Patients taking Qsymia should have their heart rates monitored regularly. People who have had recent heart disease or strokes, or whose condition is unstable, should not take the drug because of the associated heart risks. Vivus has agreed to continue monitoring users of the drug for side effects, and in particular it is conducting a long-term cardiovascular trail to more accurately assess the effect of the drug on heart attacks and stroke.
Which drug is preferable, Qsymia or Belviq?
In comparing clinical trials, Qsymia helped people lose more weight than Belviq did, the latter resulting in only 5.8% in body weight-loss after one year. However, based upon the side effects profiles of the two drugs, some could consider Belviq to be less risky.
Why Was the FDA’s Approval so Important?
Because more that 33% of American adults are overweight or obese, and this statistic has been growing steadily. There aren’t many effective weight-loss strategies out there that can reverse the trend. There are very few options for patients aside from diet changes, exercise, and weight-loss surgery. Qsymia’s approval by the FDA after a lengthy drought of diet-drug approvals, marked a willingness for the FDA to make new weight-loss solutions available.
If you need help losing a significant amount of weight, Qsymia might be right for you. Talk to your doctor to learn more about the risks of using the weight-loss drug, so that you can make a decision that is right for you.