FDA Requires Boxed Warning for All Botulinum Toxin Products

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FDA Requires Boxed Warning for All Botulinum Toxin Products

fda.gov

Prompted by reports of serious adverse events, the U.S. Food and Drug Administration today announced that safety label changes, including a boxed warning, and a Risk Evaluation and Mitigation Strategy (REMS), are necessary for all botulinum toxin products.

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Tags: Botulism, Drug, FDA

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Most Recently Shared on June 10, 2009 at 5:04 pm By:

Nurse_com Gannett Healthcare

FDA requires boxed warning on all botulinum toxin products: http://bit.ly/Zl93J

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jama.ama-assn.org — “BlockedView full resource at jama.ama-assn.org

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Most Recently Shared on June 12, 2009 at 7:22 pm By:

JAMA_current JAMA Medical Journal

FDA Requires Black Box Warnings on Labeling for Botulinum Toxin Products http://tinyurl.com/m5d4nv

3 years ago...

FDA requires strong ’black box’ warning for Botox, others - - ModernMedicine

modernmedicine.com — “Botulinum toxin products must carry a strong "black box" warning on potentially lethal risks, the U.S. Food and Drug Administration (FDA) announced April 30.View full resource at modernmedicine.com

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FDA requires strong ’black box’ warning for Botox, others http://twurl.nl/cgxego

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Manufacturers of botulinum toxin products (Botox, Botox Cosmetic, Myobloc) required to strengthen warnings - MPR

empr.com — “The FDA has notified healthcare professionals that it is requiring the manufacturers of licensed botulinum toxin products, including Botox and Botox Cosmetic (botulinum toxin type A, from Allergan) and Myobloc (botulinum toxin type B, from Solstice Neurosciences), to strengthen warnings in product labeling and add a boxed warning regarding the risk of adverse events when the effects of the toxin spreads beyond the injection site.View full resource at empr.com

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Most Recently Shared on April 30, 2009 at 8:05 pm By:

eMPR MPR Medical Publisher

MPR News: Manufacturers of botulinum toxin products (Botox, Botox Cosmetic, Myobloc) required to streng.. http://tinyurl.com/c674rf

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