Safety Alerts & Recalls

What does this mean?

The new boxed warning emphasizes the importance of recognizing the rare but serious side effects of BOTULINUM TOXIN TYPE A (BOTOX, BOTOX COSMETIC), including unexpected loss of strength or muscle weakness, hoarseness or trouble talking (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids. These adverse events have been reported as early as several hours and as late as several weeks after treatment. If you are receiving treatment with BOTULINUM TOXIN TYPE A (BOTOX, BOTOX COSMETIC) please seek immediate medical attention if you develop any of these symptoms.

New Boxed Warning

In a follow up to the safety review conducted in early 2008, the FDA is requiring manufacturers to change the labeling for botulinum products, including BOTULINUM TOXIN TYPE A (BOTOX, BOTOX COSMETIC), to include a boxed warning about the risk of adverse events when the effects of the toxin spread beyond the injection site.

For more information, please visit: more information here

Source: FDA
Publication Date: 2009-05-01
Last Updated: 2009-12-05

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