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Jul
09

FDA Approves New Weight Loss Pill

It’s big news!   For the first time in about thirteen years, the FDA has approved a new weight loss drug, Belviq.    It will be prescribed only for people whose BMI has reached the “obese” category or people whose BMI is in the “overweight” category and who have at least one weight related health problem such as diabetes.

According to a press release from Belviq manufacturer, Arena Pharmaceuticals, the efficacy of Belviq was proven by “Three double-blind, randomized, placebo-controlled trials demonstrated that BELVIQ along with diet and exercise was more effective than diet and exercise alone at helping patients lose 5% or more of their body weight after one year and managing the weight loss for up to two years.”

Wait a minute…5%?   At 300 pounds, that would be a loss of 15 pounds.  I’m not sure that is really all that significant–particularly in light of the list of possible side effects.   According to the same press release, these include: .

  • 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.
  • 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
  • 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.
  • Response to BELVIQ should be evaluated at 12 weeks of treatment to determine if therapy should be discontinued.

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