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美国FDA发布肉毒毒素A和肉毒毒素B的安全性评估数据的早期结果。声称这些产品所导致的系统性不良反应包括:呼吸窘迫及死亡和肉毒毒素中毒。报道的病例大多为儿童,这些儿童应用肉毒毒素治疗脑瘫而导致的肢体痉挛,在美国,这是未经批准的适应证。美国FDA认为,肉毒毒素用于治疗脑瘫导致的肢体痉挛,其有效性、安全性及剂量没有得到充分评估,所以肉毒毒素不允许用于12岁以下的儿童。对肉毒毒素的安全性数据评估结束后,美国FDA建议医生:
US FDA Releases Early Results of Safety Evaluation of Botulinum Toxin A and Botulinum Toxin B. The systemic adverse reactions caused by these products include respiratory distress and death and botulism toxin poisoning. Most of the reported cases were children who had botulism treated with botulinum toxin for the treatment of limb spasms. In the United States, this is an unapproved indication. According to the U.S. FDA, botulinum toxin is not used in children under 12 years of age for the treatment of limb spasticity caused by cerebral palsy. Its efficacy, safety and dosage have not been adequately evaluated. After evaluating the safety of botulinum toxin data, the FDA advises doctors to: