Hive Health Media

Belviq : A Triumph of Money over Common Sense?

Earlier today, 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 health advisers 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 week 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 medicines for depression, migraine, the common cold, and mood, anxiety, psychotic or thought disorders or other medical problems may affect each other causing serious or life-threatening side effects. Patients should tell their doctor if they are taking medicines to treat any of these conditions such as: triptans, tricyclics, lithium, selective serotonin uptake inhibitors (SSRIs), selective serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), or antipsychotics; linezolid, an antibiotic; tramadol; dextromethorphan, an over-the-counter medicine used to treat the common cold or cough; over-the-counter supplements such as tryptophan or St. John’s Wort. BELVIQ and these medicines should be discontinued immediately and symptomatic treatment measures should be initiated if patients taking BELVIQ and these other medicines experience any of the following: mental changes such as agitation, hallucinations, confusion, or other changes in mental status; coordination problems, uncontrolled muscle spasms, or muscle twitching (overactive reflexes); restlessness; racing or fast heartbeat, high or low blood pressure; sweating or fever; nausea, 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. Patients taking BELVIQ who have trouble breathing, swelling of the arms, legs, ankles, or feet, dizziness, fatigue, or weakness that will not go away, or fast or irregular heartbeat should call their doctor right away. Before taking BELVIQ, patients should tell their doctor if they have or had heart problems including congestive heart failure, or heart valve problems. Patients should not take BELVIQ in combination with drugs that have been associated with valvular heart disease (such as cabergoline). Patients who develop signs and symptoms of valvular heart disease while taking BELVIQ 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 in patients taking BELVIQ. 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: hallucinations, feeling high or in a very good mood (euphoria), feelings of standing next to yourself or out of your body (disassociation). The recommended dose of 10 mg twice daily should not be exceeded. Patients should be monitored for the development or worsening of depression, suicidal thoughts or behaviors, and/or any changes in mood. BELVIQ 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 who are on medicines to treat it such as metformin, insulin, or sulfonylureas. Blood sugar levels should be monitored for 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 is painful or not, they should stop using BELVIQ and call their doctor or go to the nearest emergency room right away. BELVIQ should be taken with caution by men who have conditions that might predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia), or in men with a deformed penis. Patients should tell their doctor if they take medicines used to treat erectile dysfunction.
  • Slow Heartbeat: BELVIQ may cause a slow heartbeat. Patients taking BELVIQ should tell their doctor if they have a 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 tests 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 taking BELVIQ should tell their doctor if their breasts begin to make milk or have a milky discharge or if their breasts begin to increase in size.
  • Increased Pressure in the Arteries of the Lung (Pulmonary Hypertension): Certain weight loss drugs have been associated with the rare but life-threatening side effect of increased pressure in the arteries of the lung. It is unknown if BELVIQ increases the risk for this condition.
  • Most Common Adverse Reactions In Non-Diabetic Patients: Headache, dizziness, fatigue, nausea, dry mouth, and constipation.
  • Most Common Adverse Reactions in Diabetic Patients: Hypoglycemia, headache, back pain, cough, and fatigue.

In comparison:

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

Reference

Doug Robb is a personal trainer, a fitness blogger and author, a competitive athlete, and a student of nutrition and exercise science. He's also the co-founder of the Hive Health Media. Since 2008, Doug has expanded his impact by bringing his real-world experience online via the health & fitness blog – Health Habits.

2 Comments

  1. mike lewis

    March 4, 2013 at 4:33 pm

    you seem like a vvus pumper. belviq has had greater than 10% weight loss with some obese patients in studies. these individuals need a solution and taking a drug should help them – belviq is much safer than vvus’ drug so why not try it along with an exercise plan?

  2. BrandtHardin

    June 27, 2012 at 3:09 pm

    Big Pharma is the REAL drug cartel in North America. Their overmedicating of the American public through obscene advertising leads to nearly 100,000 deaths per year!  Prescription drugs are more dangerous than any felony drug substance in the world including heroin, cocaine and even alcohol combined.  Read about this issue and what’s killing people at http://dregstudiosart.blogspot.com/2011/07/illustration-friday-800-milligrams.html

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