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# FDA Okays weight loss drug Qsymia, would you take it?
- URL: https://www.foodconsumer.org/fda_okays_weight_loss_drug_qsymia_0722120843/
- Published: 2012-07-22T21:41:00.000Z
- Updated: 2026-09-22T15:50:50.000Z
- Description: The FDA cleared Vivus's Qsymia, a phentermine and topiramate combination, on July 17 for obese adults or overweight adults with a weight-related condition, to be used alongside a reduced-calorie diet and exercise. Women who may become pregnant should not take it.
- Author: Food Consumer
- Tags: Drug, Health News, #vivvo-import

By David Liu PHD

Sunday July 22, 2012 (foodconsumer.org) -- Vivus Inc. in Mountain View, Calif. has been granted permission to market a weight loss management medication called Qsymia, the Food and Drug Administration announced on July 17.

Qsymia, a combination of two drugs, phentermine and topiramate, thich have early been approved by the FDA, does not work alone. It is intended to be used as a supplementary remedy to a calorie-reduced diet and physical exercise for chronic weight loss management.

The drug is indicated for use in obese adults or overweight adults with one weight-related condition as as high blood pressure or hypertension, diabetes type 2, or high cholesterol (dyslipidemia). Obese adults are those who have a body mass index (BMI) of 30 kg/m2 or greater.

In the U.S., more than 1 third of adults are considered obese, according to the Centers for Disease Control and Prevention. Obesity is associated with a range of serious health conditions such as metabolic syndrome, diabetes, and cardiovascular disease.

Phentermine is intended for short-term weight loss in overweight or obese adults who are exercising and eating a calorie restricted diet. Topiramate is indicated to treat certain types of seizures in people who suffer epilepsy to prevent migraine headaches. 

Qsymia is not for every adult. Pregnant women or child-bearing women who intend to get pregnant should not use this drug as it can cause damage to the fetus. Before using Qsymia and every month while using it, child-bearing women should have a negative pregnancy test. To prevent pregnancy, an effective contraception should be consistently used while taking Qsymia.

The FDA approved the drug based on results from two randomized, placebo-controlled one-year trials of a total of 3700 obese and overweight patients with or without weight-relayed conditions (it is unknown whether or not they were double-blind and bias were minimized in the trials). All patients modified their lifestyle, that is, using a calorie restricted diet and engaging in regular physical exercise.

In one trial, the study arm lost 6.7 percent more weight than the control group and in another, the study group lost 8.9 percent more weight than the control group. In the study groups of two trials, 62 and 69 percent respectively lost at least five percent of their body weight, compared to about 20 percent in the control group.

The FDA said obese or overweight adults who did not lose at least three percent of their body weight by week 12 of treatment with Qsymia were unlikely to reach the weight loss goal. Because of this, an evaluation about the efficacy of the treatment by 12 weeks is advised.

Qsymia should not be used to treat patients with glaucoma or hyperthyroidism either because the drug can increase heart rate. Patients who have a recent heart attack or stroke should not use the medication for the same reason. Regular monitoring of heart rate is recommended for all patients taking this drug.

A health observer suggested this type of weight loss drug is similar to another medication called Alli approved early by the FDA. That is, they can't work alone to be effective.

By taking a calorie-restricted diet and engaging in physical activity alone, any obese and overweight adult should be able to lose weight. The health observer suggested that it is critical that you eat foods as slowly as you can, which can maximally minimize your intake of calories. Reduced intake of calories is the driving force for weight loss.