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Safety Alert: Onabotulinumtoxina
Early communication regarding FDA safety review
What does this mean?
While it will take some time for the FDA to provide further guidance on the results of its review, today's announcement is a reminder that - like all products - botulinum toxin has risks that need to be carefully balanced against benefit before starting treatment. If you are currently receiving treatment with this product, or are planning to start treatment in the near future, ensure that your doctor is aware of today's announcement - and takes normal precautions when administering treatment.
The FDA issued an announcement today that it is conducting a safety review of BOTOX and BOTOX COSMETIC. This communication follows reports of serious breathing difficulties which may have been caused by botulinum toxin spreading beyond the site where it was injected. The most serious reports, which resulted in hospitalization and sometimes death, mostly involved children treated for cerebral palsy-associated problems.
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