FDA要求加强肉毒杆菌毒素产品的标签警告部分

ST LOUIS (MD Consult) - On April 30, 2009, the US Food and Drug Administration (FDA) issued a follow-up notification about actions taken in regard to data derived from a continuing safety review of licensed botulinum toxin products. Manufacturers of these products will now be required to strengthen warnings in product labeling and to add a boxed warning regarding the risk of adverse events that may occur when the effects of the toxin spread beyond the injection site.

The FDA will also require that manufacturers of botulinum toxin products develop and implement a Risk Evaluation and Mitigation Strategy (REMS), including a communication plan to provide more information regarding the risk for distant spread of botulinum toxin effects after local injection, as well as information to explain that botulinum toxin products cannot be interchanged. The REMS would also include a medication guide that explains these risks to patients, their families, and caregivers. In addition, as a means to further assess the risk of distant spread of toxin effects, the FDA is requiring manufacturers to submit safety data gathered from a specified number of children and adults with spasticity after they have received multiple administrations of the product.

The FDA's evaluation of the data continues to support the recommendations made in their 2008 early communication on the safety of botulinum toxins types A and B.
 

圣路易斯（MD consult）——美国FDA在对获批的肉毒杆菌毒素产品的安全性资料进行持续审查后，于2009年4月30日发布了一项补充公告，要求这些产品的生产厂家加强药品标签上的警告部分，并且要增加黑框警告，标明当毒素播散到注射部位以外时有产生不良反应的危险。

FDA还要求肉毒杆菌毒素的生产厂家制定并实施风险评估和减缓策略（REMS），其中包括一套信息交流方案。该方案用于提交关于肉毒杆菌毒素局部注射后效应向远端扩散的危险性详细信息以及说明肉毒杆菌毒素产品间不能互换使用的信息。REMS中还应包含用药指南，告知患者及其亲属及护理人员可能存在的危险。另外，为进一步评价毒素效应远端扩散的风险，FDA还要求生产厂家提交规定例数的儿童及成年痉挛患者多次使用该产品后的安全性资料。

FDA关于这些资料的评价结果支持其在2008年A型和B型肉毒杆菌毒素安全性早期报告中制定的建议指南。

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