Liguori Valerio, Anatriello Antonietta, Cantone Andrea, Nicoletti Maria Maddalena, Argenziano Giuseppe, Scavone Cristina, Pieretti Gorizio
Department of Experimental Medicine, University of Campania "Luigi Vanvitelli", Naples, Italy.
Regional Center of Pharmacovigilance and Pharmacoepidemiology of Campania Region, 80138, Naples, Italy.
Aesthetic Plast Surg. 2025 Apr;49(7):2032-2039. doi: 10.1007/s00266-024-04564-3. Epub 2024 Dec 5.
Botulinum toxin type A (BTA) is a protein produced by Clostridium botulinum bacteria. It is the most widely used among botulinum toxin types, and it is recommended for the treatment of many clinical conditions, including muscle hyperactivity syndromes and for esthetic indications too. BTA is generally considered safe, and the most reported adverse events (AEs) include eyelids ptosis, immunogenicity, neuromuscular disorders and hypersensitivity reactions. In addition, serious idiosyncratic AEs, such as anaphylactic shock, have been highlighted.
Taking into account that BTA skin toxicity has been already investigated recently by our research group and that, in many cases, the BTA-induced skin toxicity represents a symptom of an hypersensitivity reaction, the aim of the present study was to better characterize cases of anaphylaxis occurring after intramuscular administration of BTA by analyzing Individual Case Safety Reports (ICSRs) sent to the EudraVigilance database.
A total of 86 ICSRs, covering 449 Preferred Terms, reporting BTA as suspected drug and "anaphylactic reaction," "anaphylactic shock," "anaphylactoid reaction" or "anaphylactoid shock" as ADR were suitable for our analysis. The majority of patients who experienced BTA-induced anaphylaxis were female (89.5%) and mostly belonged to the age group 18-64 years. The most common outcome was "recovered/resolved," while the seriousness criteria was mostly reported as "caused/prolonged hospitalization."
Our results showed that anaphylactic reactions may occur after esthetic use of BTA; thus, a close monitoring before, during and after BTA intramuscular injection is highly recommended in order to prevent the occurrence of this event and ensure an appropriate management of the patients receiving this drug.
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A型肉毒杆菌毒素（BTA）是由肉毒梭菌产生的一种蛋白质。它是肉毒杆菌毒素类型中使用最广泛的，被推荐用于治疗多种临床病症，包括肌肉活动亢进综合征以及美容适应症。BTA一般被认为是安全的，最常报告的不良事件（AE）包括眼睑下垂、免疫原性、神经肌肉疾病和过敏反应。此外，严重的特异质性不良事件，如过敏性休克，也受到了关注。
鉴于我们的研究小组最近已经对BTA的皮肤毒性进行了研究，并且在许多情况下，BTA诱导的皮肤毒性是过敏反应的一种症状，本研究的目的是通过分析发送到欧洲药品不良反应数据库（EudraVigilance）的个体病例安全报告（ICSR），更好地描述肌肉注射BTA后发生过敏反应的病例。
共有86份ICSR，涵盖449个首选术语，将BTA报告为可疑药物，将“过敏反应”“过敏性休克”“类过敏反应”或“类过敏性休克”报告为药品不良反应，适合我们的分析。经历BTA诱导过敏反应的大多数患者为女性（89.5%），主要属于18 - 64岁年龄组。最常见的结果是“恢复/缓解”，而严重程度标准大多报告为“导致/延长住院时间”。
我们的结果表明，美容使用BTA后可能发生过敏反应；因此，强烈建议在BTA肌肉注射前、注射期间和注射后进行密切监测，以防止该事件的发生，并确保对接受该药物治疗的患者进行适当管理。
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