| Subject: | FDA Requires Boxed Warning for All Botulinum Toxin Products |
| Category: | Food and Drug Administration (FDA)
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| Published: | Fri, 1 May 2009 - 09:00 am |
| The Food and Drug Administration (FDA) is notifying healthcare professionals that after an ongoing safety review initiated in February 2008, the manufacturers of licensed botulinum toxin products are required to strengthen warnings in product labeling and add a boxed warning regarding the risk of adverse events when the effects of the toxin spread beyond the site where it is injected. The FDA is also requiring that manufacturers develop and implement a Risk Evaluation and Mitigation... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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