| Subject: | FDA Requires Boxed Warning for All Botulinum Toxin Products |
| Category: | Food and Drug Administration (FDA)
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| Published: | Wed, 10 Jun 2009 - 11:00 am |
| Prompted by reports of serious adverse events, the U.S. Food and Drug Administration (FDA) has announced that safety label changes, including a boxed warning, and a Risk Evaluation and Mitigation Strategy (REMS), are necessary for all botulinum toxin products. This action updates a February 2008 announcement that the FDA was conducting an ongoing safety review of botulinum toxin products. The agency said it took the action because of reports that the effects of the botulinum... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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