Earlier today,Â U.S. health regulators approved Arena Pharmaceuticals’ new weight loss pill, Belviq, making it the first new weight-loss drug in 13 years.
- Arena shares jumped more than 45 percent following the announcement.
At first glance, this looks like a real win-win for the American public…
- a promise to reduce America’s waistline combined with
- a nice little boost to America’s economic bottom line.
Unfortunately, as part of the FDA approval, Arena will be required to conduct six post-marketing studies, including a long-term heart study to assess whether Belviq increases the risk of heart attack or stroke.
The studies are designed to address the concerns of FDA healthÂ advisersÂ who recommended:
“Additional studies should be conducted to explore the issue of prolactin, tumor development, psychiatric effects and possible drug/drug interaction since this drug will probably be used in combination with other drugs. Echocardiogram should be required at the initiation of therapy and possibly at yearly physical check up.”
Of course the advisory group recommended that these studies be performed prior to FDA approval…but what difference can that possibly make.
It’s not like there are millions of overweight Americans willing to ignore obvious health concerns in order to shed a few pounds.
[box type=”note”]BTW, if you didn’t catch my sarcasm, you may want to Google fen-phen side effects[/box]
Let’s ignore side-effects for a moment
Let’s say that all these health concerns are being blown out of proportion. We already know that obesity (not overweight) is correlated to a bunch of very expensive to treat chronic illnesses like diabetes, heart disease & cancer.
Q: Doesn’t that make Belviq a boon to the healthcare industry?
A: It certainly would…. obesity is a huge drain on the health & wealth of the American population. Unfortunately, Belviq (aka lorcaserin) doesn’t look like it’s got the skills to reverse America’s obesity epidemic.
- After 52 weeks, the placebo patients lost 2.5% of their body-weight. This means that a 300 lb test subject would have lost only 7.5lbs over 52 weeks. But what can you expect from a sugar pill?
- In comparison, the Belviq patients lost an average of 5.83% of their body-weight over 52 weeks. This means that our imaginary 300 lb guinea-pig would have dropped 17.5 lbs…. for a difference of 3.33% or 10 lbs…. over 52 weeks… for an average of 0.19 lbs per week.
That’s what Belviq did for their test subjects.
An extra 0.19 lbs of fat loss per weekÂ in return for a whole whack of contraindications and safety warnings….
- Pregnancy: BELVIQ should not be taken during pregnancy or by women who are planning to become pregnant.
- Nursing: BELVIQ should not be taken while breastfeeding.
- Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions: BELVIQ and certain medicinesÂ for depression, migraine, the common cold, and mood, anxiety, psychotic or thought disorders or other medical problemsÂ may affect each other causing serious or life-threatening side effects. Patients should tell their doctor if they are takingÂ medicines to treat any of these conditions such as: triptans, tricyclics, lithium, selective serotonin uptake inhibitorsÂ (SSRIs), selective serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), orÂ antipsychotics; linezolid, an antibiotic; tramadol; dextromethorphan, an over-the-counter medicine used to treat theÂ common cold or cough; over-the-counter supplements such as tryptophan or St. John’s Wort. BELVIQ and theseÂ medicines should be discontinued immediately and symptomatic treatment measures should be initiated if patients takingÂ BELVIQ and these other medicines experience any of the following: mental changes such as agitation, hallucinations,Â confusion, or other changes in mental status; coordination problems, uncontrolled muscle spasms, or muscle twitchingÂ (overactive reflexes); restlessness; racing or fast heartbeat, high or low blood pressure; sweating or fever; nausea,Â vomiting, or diarrhea; or muscle rigidity (stiff muscles).
- Valvular Heart Disease: Certain weight loss drugs have been associated with problems with the valves in the heart.Â Patients taking BELVIQ who have trouble breathing, swelling of the arms, legs, ankles, or feet, dizziness, fatigue, orÂ weakness that will not go away, or fast or irregular heartbeat should call their doctor right away. Before taking BELVIQ,Â patients should tell their doctor if they have or had heart problems including congestive heart failure, or heart valveÂ problems. Patients should not take BELVIQ in combination with drugs that have been associated with valvular heartÂ disease (such as cabergoline). Patients who develop signs and symptoms of valvular heart disease while taking BELVIQÂ should be evaluated and discontinuation of BELVIQ should be considered by their doctor.
- Changes in Attention or Memory: Problems with thinking, sleepiness, confusion, and fatigue have been reported inÂ patients taking BELVIQ.Â Patients taking BELVIQ should not drive a car or operate heavy machinery until they know how BELVIQ affects them.
- Mental Problems: Taking BELVIQ at higher than the recommended dose may cause psychiatric problems such as:Â hallucinations, feeling high or in a very good mood (euphoria), feelings of standing next to yourself or out of your bodyÂ (disassociation). The recommended dose of 10 mg twice daily should not be exceeded. Patients should be monitored forÂ the development or worsening of depression, suicidal thoughts or behaviors, and/or any changes in mood. BELVIQÂ should be discontinued if patients develop suicidal thoughts or behaviors.
- Low Blood Sugar (Hypoglycemia): Weight loss can cause low blood sugar in people with type 2 diabetes mellitus whoÂ are on medicines to treat it such as metformin, insulin, or sulfonylureas. Blood sugar levels should be monitored forÂ patients who take BELVIQ. Changes to medicines may be needed if low blood sugar develops.
- Painful Erections (Priapism): If patients taking BELVIQ experience an erection lasting more than 4 hours, whether it isÂ painful or not, they should stop using BELVIQ and call their doctor or go to the nearest emergency room right away.Â BELVIQ should be taken with caution by men who have conditions that might predispose them to priapism (e.g., sickleÂ cell anemia, multiple myeloma, or leukemia), or in men with a deformed penis. Patients should tell their doctor if they takeÂ medicines used to treat erectile dysfunction.
- Slow Heartbeat: BELVIQ may cause a slow heartbeat. Patients taking BELVIQ should tell their doctor if they have aÂ history of a slow heartbeat or heart block.
- Decreases in Blood Cell Count: BELVIQ may cause decreases in red or white blood cell count. A doctor may do testsÂ to check a patient’s blood cell count during treatment with BELVIQ.
- Increase in Prolactin: BELVIQ may increase the amount of a hormone the body makes, called prolactin. Patients takingÂ BELVIQ should tell their doctor if their breasts begin to make milk or have a milky discharge or if their breasts begin toÂ increase in size.
- Increased Pressure in the Arteries of the Lung (Pulmonary Hypertension): Certain weight loss drugs have beenÂ associated with the rare but life-threatening side effect of increased pressure in the arteries of the lung. It is unknown ifÂ BELVIQ increases the risk for this condition.
- Most Common Adverse Reactions In Non-Diabetic Patients: Headache, dizziness, fatigue, nausea, dry mouth, andÂ constipation.
- Most Common Adverse Reactions in Diabetic Patients: Hypoglycemia, headache, back pain, cough, and fatigue.
- 52 weeks of Best Body workouts combined with a healthy Paleo-style nutrition plan will sure as heck deliver more than a 5.83% loss in body fat.
- And the side effects will include vastly improved levels of health, fitness & general awesomeness.
Just say no to Belviq.
Vivus’s weight loss drug Qnexa is up for FDA approval on July 17. Based upon this ruling and the Qnexa test results, it seems like a slam dunk. Stay tuned
- FDAÂ Press Release
- FDA Health Adviser Report
- The Street
- Bye Bye Healthy Lifestyle : Hello Qnexa
- Qnexa Review
- Health Advisers Advocate Assessing Heart Risks on Obesity Drugs
- QNEXA: Money & Politics v.s. Science & Common Sense
- Qnexa Approval by the FDA?
- Why Lorcaserin And Other Weight Loss Drugs Fail To Deliver
- Belviq package insertÂ