Everyone is searching for the “magic pill” that will help us quickly, safely, and painlessly help us lose weight and keep it off. The pharmaceutical company who develops a weight loss pill that works and is safe stands to make a hefty profit. Weight loss drugs come and go, and the reason they go is usually due to harmful side effects like heart valve problems or increased risk of heart attack or stroke.
The latest weight loss drug, Belviq, was initially approved by the Food and Drug Administration (FDA), but the Drug Enforcement Agency (DEA) stepped in to slow its release. Yes, you read that right; the DEA slowed the release of a diet drug. The DEA recommended that Belviq be released as a Schedule IV controlled substance because it has hallucinogenic properties and users could develop psychiatric dependency on the drug.
So, the release was held up for a short time and in June, 2013, Belviq was released.
Promises, promises…but to what end?
This new drug, Belviq (lorcaserin), is made by Arena Pharmaceuticals and is promoted as an appetite suppressant; also known as an anorectic. Taking the pill should make a person not desire to eat and feel full.
The FDA approved the medication for people who are obese (with a body mass index, or BMI, of 30 or higher) or who are overweight (with a BMI of 27 or above) and also have at least one weight-related health condition such as hypertension, high cholesterol, type 2 diabetes. This applies to over 68% of the US population.
Interestingly, Belviq is a serotonin 2C receptor agonist. You probably have heard of SSRI’s as many antidepressants and antipsychotic medications fit in this category.
Read the Fine Print:
Information on Belviq is clear in stating that the patient “should be considered obese or overweight with health issues and take the medication along with diet and exercise”. Oh…diet and exercise, too? Now there’s a twist.
A significantly overweight person must take this medication AND diet and exercise. Maybe it would be worth if it a large amount of weight could be lost and kept off. So, how much weight will be lost IF a person diets, exercises, AND takes the medication?
Well, after one year, about 5% of starting weight is lost. In the study, after a year of Belviq, diet, and exercise, the average weight loss was 12.5#. Arena Pharmaceuticals recommends discontinuing the drug if 5% of weight is not lost in the first 3 months as it will unlikely promote meaningful weight loss if it hasn’t worked by then.
So, a 5’3”, 250# woman taking Belviq as well as dieting, and exercising can expect to lose 12.5 pounds in a year. After a year with diet, exercise, and the drug..she would still weigh 237.5 pounds. Without the medication in trials, she would expect to lose 7.5 pounds through diet and exercise. So, adding this medication that was held up by the DEA will promote an extra 5 pounds in a year? (I have had patients gain 5 pounds in a week).
**Less than 50% of dieters without diabetes lost 5% of body weight (by recommendations, they should have been off the medication after 3 months without a 5% loss in weight).
Longterm (between 2-3 years), lost weight is regained. When medication is stopped, weight is regained.
What are Belviq’s side effects?
The most common side effects of Belviq in non-diabetic patients are headache, dizziness, fatigue, nausea, dry mouth and constipation. Patients with diabetes may also experience low blood sugar, headache, back pain, cough and fatigue.
There was also some concern that Belviq caused tumors in animals and heart-valve defects in people. A similar serotonin-based drug, fenfluramine, had been approved for weight loss but was removed from the market in 1997 because of the same heart concerns. Patients who develop signs or symptoms of heart valve disease, including difficulty breathing, fluid retention, congestive heart failure, or a new heart murmur while being treated with BELVIQ should be evaluated and discontinuation of BELVIQ should be considered.
It is recommended that those who take Belviq should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. If suicidal thoughts surface, Belviq should be discontinued.
The drug may cause a decrease in attention, memory, focus, or cognition. Clarity of thought and ability to remember may be affected.
While taking Belviq, patients should seek emergency treatment if an erection lasts over four hours.
So there you have it. The stock market awaits the release of this marginally effective “weight loss drug.” To be effective, it is to be used with diet and exercise. It does not promote significant weight loss for those who are obese or overweight and have weight related illness. If it doesn’t “work” in three months, it most likely will not work. Weight is typically regained if the patient stays the course. It should not be taken by those on certain antidepressants or antipsychotic medications. It may cause heart valve damage, increase suicidal ideation, and depression. And…it may be related to impaired thoughts, memory, and attention.
Worth it? I suppose that any weight loss drug is financially “worth buying into” as there will likely be a windfall when it is first mass advertised and prescribed. “Worth buying into” health-wise? Patients will have to make that decision. I hope they make that decision in an informed way.