Wie gefährlich ist die medizinische Anwendung von Botulinumtoxin?

Zusammenfassung

Der Erfolg des therapeutischen Einsatzes von Botulinumtoxin seit über 20 Jahren in der Neurologie führte zu einer breiten Akzeptanz dieser giftigsten bekannten biologischen Substanz. Aufgrund der Datenmenge, die wir zur Verfügung haben, gilt die Botulinumtoxintherapie in der Hand des Experten als ein sicheres Therapieverfahren. Zuletzt haben aber wiederholt Berichte in der Boulevardpresse über Todesfälle bei der Anwendung von Botulinumtoxin zu großer Verunsicherung geführt. Auch aus diesem Grund hat das Bundesinstitut für Arzneimittel und Medizinprodukte am 04. September 2008 eine Stellungnahme veröffentlicht. Letztlich sind trotz hunderttausendfacher Anwendung seit der Zulassung in Deutschland 1993 nur 210 Verdachtsfälle schwerer unerwünschter Wirkungen von Botulinumtoxinmedikamenten gemeldet worden, wobei in keinem dieser Fälle ein ursächlicher Zusammenhang mit der Anwendung von Botulinumtoxin sicher erwiesen sei. Zu einem vergleichbaren Ergebnis kam die US Food and Drug Administration wenige Jahre zuvor. Somit gilt nach wie vor, dass bei Einhaltung der empfohlenen Höchstdosen und Würdigung der Begleiterkrankungen multimorbider Patienten systemische Nebenwirkungen extrem selten und bei kosmetischen Indikationen keine Todesfälle beschrieben sind. Möglicherweise steigt die Häufigkeit systemischer Nebenwirkungen durch eine noch genauere Beobachtung unserer Patienten nach Botulinumtoxinbehandlung an.

Summary

The therapeutic application of botulinum toxin in neurology for more than 20 years has lead to a great acceptance of this toxic biological substance. Due to data and experience the treatment with botulinum toxin through an expert is safe. Because of recent articles in the yellow press about death after botulinum toxin treatment patients are uncertain. That was the reason for a statement from the Bundesinstitut für Arzneimittel und Medizinprodukte in 2008. Since 1993 and after thousands of applications only 210 suspicions of severe adverse events were reported, but a casual connection to botulinum toxin could never be shown. The American Food and Drug Administration has the same results. Therefore, rare severe adverse effects can be obtained when dosage is respected and special attention to patients with comorbidity is given. There were no deaths in cosmetics, yet. Because of a closer observation of patients, there could be more adverse events seen.

Schlüsselwörter

Botulinumtoxin - Nebenwirkungen - Sicherheit - Dystonie - Botulismus

Keywords

Botulinum toxin - adverse events - safety - dystonia - botulism

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