Thursday, June 28, 2012

FDA Approves Diet Drug Belviq: Our Take

Steve: I wonder who had to twist the FDA's arm to get this one approved? With the litany of exclusions and warnings, can anyone really take Belviq anyway?
  • What's the takeaway from the research? According to a September 2010 FDA Advisory Committee presentation, after two years, all the weight the subjects lost (which was only mean 3.3%), was regained while still on the treatment (see slide 40 at this link:
  • Impact on diabetes patients, the ones who could benefit the most, is unknown.
  • Long-term effects on cardiovascular outcomes in the general population: unknown
  • Affects heart valves, causes psychiatric and cognitive effects, serotonin syndrome in humans, and carcinogenicity in animals.
  • Versus placebo, there is an increased risk of valvular heart disease
  • Versus placebo, depression symptoms were far greater in drug than placebo, including memory impairment, disturbance in attention, and insomnia.
  • Versus placebo, there is a slight increase in suicidal behavior.
  • Other adverse mental effects versus placebo: feeling abnormal, confusional state, feeling drunk, and hallucinations. 
Wow! The potential for all of these issues and the return is a meager 3.3% of weight loss?

The drug works to control the appetite through receptors in the brain and was approved as additional therapy for certain overweight and obese patients, combined with diet and exercise.

It is approved for use in obese adults with a body mass index of 30 or greater, or overweight adults with a BMI of 27 or greater who have at least one other condition such as high blood pressure, type 2 diabetes, or high cholesterol.

The FDA warned that Belviq is not for women who are pregnant or nursing, and called for further long-term postmarketing studies on the drug's potential risks.

The label will also recommend that Belviq be discontinued in patients who fail to lose five percent of their body weight after 12 weeks of treatment.

Belviq activates the serotonin 2C receptor in the brain, and may cause serious side effects if taken in combination with certain medications for depression and migraine that increase serotonin levels or activate serotonin receptors.

Belviq (Lorcaserin) was rejected in 2010 by the Endocrinologic and Metabolic Drugs Advisory Committee, which advises the FDA, over concerns that it formed breast tumors in rats. But those effects did not appear in trials on overweight and obese humans.

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