The tide has turned for weight loss in this country as the FDA has now approved Belviq and Qsymia. Belviq was the first one approved and it belongs to a unique family (class) of medicines called serotonin 2C receptor agonists. Let’s take a closer look.
More than 33% of the US population is obese…an alarming statistic since obesity increases risk for diabetes, heart disease, kidney disease and stroke. This editor has advocated calling being overweight a fat attack, since many kinds of fat actually make destructive (inflammatory) chemicals and does NOT just sit there as many of us think.
Belviq is not approved for losing small amounts of weight as some of you may have hoped. This is because there are serious possible side effects for Belviq and Qsymia. Belviq is approved for ongoing (chronic) use as part of a Comprehensive weight loss program which includes increased exercise AND diet. In the clinical tests that lead to approval, Belviq helped people who used the drug plus lifestyle changes get an average weight loss of about 3.5%.
It’s important to know that the FDA has required that Belviq be a scheduled drug because it can cause some euphoria. It is expected (although not decided) that Belviq will be a schedule 4 medicine like Qsymia. This medicine works on a kind of brain receptor called a serotonin 2C receptor. What this means is that people who take the drug will feel full after eating smaller amounts of food.
Make sure that you talk to your doctor about possible Belviq side effects. You can see the package insert at:us.eisai.com/package_inserts/BelviqPI.pdf. Things to look for include possible excess of serotonin (serotonin syndrome), changes in thinking (euphoria) or decreased attention or memory, possible suicide thoughts (call your doctor immediately and stop the medicine if this happens), possible erections lasting more than 4 hours (priapism) and possible decreased blood sugar (not studied with insulin)
Unfortunately, there were not enough people studied in the approval research to rule out an effect on heart valves. Again, this is why the FDA approved these two new medicines only for obese people (having a Body Mass Index or BMI) OR for some overweight patients (BMI of 27) who also have significant health problems such as high cholesterol, high blood pressure or diabetes. The drug will probably be available in early 2013, but the company hasn’t released an availability date since the FDA hasn’t decided what schedule the drug will be yet.
Qsymia is actually an extended release combination of Phentermine (an old weight loss drug) and topiramate (an older seizure medicine). In this combination, Phentermine works to decrease your appetite and topiramate which makes you feel fuller after eating less. There will be a healthcare provider training program for those wishing to prescribe Qsymia. Patients studied using Qsymia plus lifestyle changes (diet and exercise) realized an average weight loss of 6-9%.
You can find the package insert at www.Qsymia.com. Qsymia has a required Risk Evaluation and Mitigation Strategy (REMS) which you can also view on line. It’s crucial that this medicine NOT be taken in pregnancy. Like Belviq, it is important that you talk to your doctor about possible Qsymia side effects and what to do if they happen.
Your doctor will ask you to get a pregnancy test before starting Qsymia. They will not prescribe the medicine to you if you have glaucoma, if you have hyperthyroidism or have been taking a medicine called a monoamine oxidase inhibitor (MAOI). The drug can increase heart rate, so regular measurement of heart rate is recommended. Topiramate (part of Qsymia) can increase the risk of suicidal thoughts. Call your doctor immediately if you start to have such thoughts and stop the drug. It has not been studied in patients with recent or unstable heart or cerebrovascular disease and is not recommended in those patients either. Like Belviq, this drug may decrease mood, thinking and impair concentrations. Caution operating hazardous machinery is required. Some patients taking Qsymia have had changes in metabolic status (hyperchloremic acidosis) and the drug should be stopped if this happens. Some changes in kidney function (creatinine increase) have happened. Side effects and unexpected problems with both of these weight loss medicines can be reported to the FDA by called 1-800-332-1088.
Qsymia will be probably be available late this year (2012) and will have to be mail ordered through the Qsymia Home Delivery Network. These medicines WILL be included in the 2012 Essential Guide to Prescription Drugs. To see the new iBookstore version of the Essential Guide to Prescription Drugs, 12 Top Meds for 2012, click on the link below
The printed book can be found at
More information on both Belviq and Qsymia can be found at www.fda.gov.