FDA approves second weight loss drug in as many months.
Well, that was fast!
Just days ago the FDA approved Belviq, the first new weight loss drug in over a decade. We knew it was coming, and, yes, the FDA yesterday announced that it has also approved Qysmia for clinical use.
Everyone’s excited that we have some new weight loss tools coming to market. Just remember that you will need to talk to your health care provider about whether or not a weight loss drug is right for you.
Diet and exercise are still going to be the surest way to lose weight and keep it off… but I am sure you want to know what all the excitement is about…
How does Qsymia work?
Qsymia is a new weight loss drug from VIVUS. Chemically, it is a combination of Phentermine and Topiramate, two drugs that we already use in clinical practice.
Topiramate, or Topamax, is an anti-seizure drug that is typically used for the prevention of migraine headaches and/or seizures associated with epilepsy. We have found that one of the side effects of this drug is weight loss as it tends to give patients a feeling of “fullness” that we like to call satiety.
Phentermine, meanwhile, is a stimulant that suppresses appetite. It is commonly used in practice for weight loss management because it gives you energy and also because it promotes satiety.
Is this drug right for me?
Qsymia is indicated for obese adults (BMI > 30) or for overweight adults (BMI > 27) who have a weight-related medical problem. It comes in four different strengths and is dosed once daily.
How much weight should I expect to lose?
The percentage of weight loss varied in clinical trials, depending on the dosage prescribed. Most patients can expect to lose 8-10% if given the higher dose.
What are the safety concerns?
I spent some time on qysmia.com looking into the health risks. The site notes that ?the effect of Qsymia on cardiovascular morbidity and mortality has not been established.?
Importantly, the drug is not to be used by women who are pregnant or intend to become pregnant due to the fetal risks associated with Topiramate. Those who are sexually active and capable of becoming pregnant should therefore have pregnancy testing before beginning the drug and every month before renewal.
If you have glaucoma, heart disease, or hyperthyroidism, Qysmia is not for you.
Reported side effects include mood disturbances, cognitive dysfunction, increased heart rate, fatigue, insomnia, dizziness, dry mouth, and constipation.
My thoughts as a health care provider:
The cost of the drug has not been decided, but it will most likely be quite expensive. The good news is that we have a lot of experience prescribing the individual components of this drug and are aware of the side effects. I am impressed with the data on the average weight loss compared to Belviq and some of the older drugs. But, I do have concerns.
Topiramate is a drug we use a lot because of its ability to prevent migraine headaches. Unfortunately, patients often complain of side effects including “cognitive slowing.” Phentermine has its own effects, and this is what Ourlife’s Dr. Paul Bradley had to say about Qsymia’s one-two punch:
“We use a lot of Phentermine. It has been around a while and we see a lot of nuisance side effects, but it?s cheap. As for Topamax (Topiramate), it works really well for what it was designed to do, but causes a lot of issues. I have patients tell me it makes them feel stupid. It often leaves people in a fog.”
Those side effects may be worth enduring if you suffer from migraine headaches, but is it worth it just to shed a few pounds? That’s a decision for you and your health care provider.
I also worry about the fetal risks associated with Topirimate. Providers will have to be diligent about monthly pregnancy tests and patients will need to be doubly-extra observant in their use of contraception.
You probably already know what I am going to say next:
The rate of obesity has triggered the desire for a quick fix, but as health care providers, we know that medicine alone will never be the solution. Medicines may help you jump-start your weight loss, but lifestyle changes are absolutely the most important tool for long-term success.
Contact us with any questions,
- Elizabeth Brennan, PA-C