Stronger Health Warnings Added to Botulinum Toxin Products Packaging
Following an ongoing product safety review, the FDA is requiring stronger health risk warnings and a new boxed warning on Botulinum Toxin product packaging.
These warnings will alert consumers of the risk of adverse health events when the effects of the toxin spread beyond the injection site.
In addition, the manufacturers of Botulinum Toxin products will also need to develop and implement a Risk Evaluation and Mitigation Strategy (REMS) that will:
- detail more information regarding the risk for distant spread of the toxin effects after Botulinum is injected
- describe how they will communicate risks to consumers
- include a Medication Guide outlining risks to patients, their families and caregivers
For a complete drug report on all serious adverse events and product quality problems, please read the FDA MedWatch at www.fda.gov/medwatch/report.htm.
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