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Sunday, July 13, 2014

Is Belviq just Fen-Fen in disguise?

There is no doubt that obesity is a serious health problem facing our nation. But is our desire for a treatment so great that a drug that was denied approval two years ago is now suddenly approved?

Thomas acknowledged, during the May meeting, that questions about heart valve safety in Belviq users had not been fully resolved. But in later interviews he called echocardiogram findings in Belviq users reassuring.

Nevertheless, it appears the FDA is willing to roll the dice.

I’m sure there will be findings of heart valve abnormalities in people taking this drug soon after it is consumed nationwide, and I already have seen news accounts of an FDA advisory meeting last month indicating that there is some concern that patients in lorcaserin clinical trials might have an increased heart valve disease risk.

And although the drug’s manufacturer will be required to conduct six post-marketing studies, including a long-term cardiovascular outcomes trial to assess the effect of Belviq on the risk for major cardiac events such as heart attack and stroke, the results of those studies will come too late for those that suffer serious side-effects.

According to the FDA, serious side effects may include: disturbance in attention or memory and serotonin syndrome – a potentially life-threatening drug reaction that causes the body to produce too much serotonin and causes symptoms of agitation, diarrhea, heavy sweating, fever, muscle spasms, tremors or mental health changes (people taking antidepressants or migraine drugs that increase serotonin levels may be at an increased risk for this side effect). The manufacturer also warns that Belviq should be used with caution in people who have congestive heart failure and the drug should also not be used during pregnancy.

Many people, including past and former users of fen-phen, will ignore this advice and start experimenting with whatever new diet drug makes it through the FDA regulatory process. Hopefully, you will be careful before starting this new drug regimen if you decide to give it a try. The advice given here is neither medical advice nor legal, but it should be common sense, especially given the FDA’s remarkably poor track record with diet drugs.

See the entire article about fenfen Belviq at Petroff Associates

More Info...
  1. Fen-Phen All Over Again? @ Slate