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    Belviq (lorcaserin) may cause serious side effects including serotonin syndrome


    Posted by .(JavaScript must be enabled to view this email address)
    Wednesday, June 27, 2012 10:00 am Email this article
    Belviq (lorcaserin hydrochloride) does not appear to cause heart valve damage the way that fenfluramine (Pondimin) and dexfenfluramine (Redux) did back in 1997 according to the Press Release from the U.S. Food and Drug Administration. Fenfluramine (Pondimin) and dexfenfluramine (Redux) seemed to cause this problem by stimulating serotonin 2B receptor on heart tissue, while Belviq (lorcaserin) appears to only stimulate serotonin 2C receptor.

    However, "drug’s manufacturer will be required to conduct six postmarketing studies, including a long-term cardiovascular outcomes trial to assess the effect of Belviq on the risk for major adverse cardiac events such as heart attack and stroke" notes the FDA Press Release.

    “In 1997, the weight-loss drugs fenfluramine and dexfenfluramine were withdrawn from the market after evidence emerged that they caused heart valve damage,” notes the FDA.

    “This effect is assumed to be related to activation of the serotonin 2B receptor on heart tissue.

    “When used at the approved dose of 10 milligrams twice a day, Belviq does not appear to activate the serotonin 2B receptor.

    “Heart valve function was assessed by echocardiography in nearly 8,000 patients in the Belviq development program.

    “There was no statistically significant difference in the development of FDA-defined valve abnormalities between Belviq and placebo-treated patients.

    “Because preliminary data suggest that the number of serotonin 2B receptors may be increased in patients with congestive heart failure, Belviq should be used with caution in patients with this condition. Belviq has not been studied in patients with serious valvular heart disease.

    “The drug’s manufacturer will be required to conduct six postmarketing studies, including a long-term cardiovascular outcomes trial to assess the effect of Belviq on the risk for major adverse cardiac events such as heart attack and stroke.

    “Belviq works by activating the serotonin 2C receptor in the brain.”

    REFERENCE

    Fda. Fda approves belviq [lorcaserin hydrochloride] to treat some overweight or obese adults. FDA News Press Release. 2012 Jun 27,
    http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm309993.htm

     

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