Yesterday the US Food and Drug Administration (FDA) approved Qsymia, a drug marketed for weight loss.
Qsymia joins another recently-approved drug, Belviq, in the weight-management drug category. Belviq was approved by the FDA to treat overweight and obese people on June 27.
Before you race to get a prescription for Qsymia from your doctor, here are a few things to know:
1) Who is qualified to take Qsymia?
The drug is only for adults who have a body mass index (BMI) of 27 or greater. They must also have at least one weight-related condition, such as high blood pressure, type 2 diabetes, or high cholesterol. (Don’t know your BMI? Use this tool and find out where you land on the global scale.)
2) How does the drug work?
Qsymia is a combination of two drugs that are also FDA-approved: phentermine and topiramate. Phentermine helps with short-term weight loss, and topiramate treats seizures in people with epilepsy or migraines.
3) How do I know Qsymia is safe?
For a drug to be approved by the FDA, it must go through a rigorous series of laboratory, animal, and human tests. After undergoing lab and animal tests, the drug company evaluated Qsymia’s effectiveness in two human trials that included 3,700 obese and overweight people. After one year of treatment, patients lost an average of 6.7 to 8.9 percent of body weight.
4) Okay, I qualify. So all I need to do is take the drug and wait?
Not quite. The FDA says in addition to taking the recommended daily dose of 7.5 milligrams of phentermine and 46 milligrams of topiramate, users have to maintain a reduced-calorie diet and exercise frequently. The participants in the study also had to modify their lifestyle by eating healthy and being more active. Those who do not shed at least 5 percent body weight after 12 weeks should discontinue using Qysmia.
5) Are there any side effects?
Common side effects include tingling hands and feet, dizziness, altered taste, insomnia, constipation, and dry mouth. The drug can also increase heart rate, so those who have experienced heart disease or a stroke within the past six months should not take Qsymia. Pregnant women cannot take Qsymia, either, as it can harm the fetus.