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Thread: FDA Adds Liver Side Effects Risk to Alli/Xenical Label

  1. #1
    Super Moderator mikaela's Avatar
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    Default FDA Adds Liver Side Effects Risk to Alli/Xenical Label

    I read this online a few days ago that last May 26, 2010, FDA approved to upgrade Alli/Xenical's label information and include the warning of possible risk for severe liver damage.

    The issue with Alli/Xenical safety started way back in 2009 when regulatory body received several reports of serious liver-related side effects. FDA established a review from preclinical trials, clinical trials, drug-utilization and post-marketing studies. The results of their review was announcement last May 26 and they identified that 12 cases of severe liver injury was linked to use of Xenical and one was associated with the use of Alli.

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  2. #2
    Senior Member kathy's Avatar
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    Oh, that would really hurt their sales. I guess it's a good thing. Users should be warned of the possible side effects in using them.

  3. #3
    Senior Member sasa's Avatar
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    How did the manufacturer react to this? Oh well, cigarette packs have warning messages too but smokers still buy them

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    Senior Member viktoria's Avatar
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    I think it's Galxo Smith.. I'm not sure.. I agree.. The warning on cigarette packs didn't affect tobacco sales at all. But then again, this one is different. So their sales might really be affected.

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