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US FDA insists boxed warning for all botulinum toxin products
Prompted by reports of serious adverse events, the US Food and Drug Administration (FDA) announced that safety label changes, including a boxed warning, and a risk evaluation and mitigation strategy (REMS), are necessary for all botulinum...
PharmaBiz:  May 5 2009 5:10AM
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Black Box Warning for Botox
-- The FDA announced today that it will require black box labeling on Botox and similar products warning of a rare but potentially life-threatening complication when the effects of the toxin spread far beyond the injection site.

The move...

WebMD:  May 1 2009 4:20AM
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