Sitaxentan [Thelin®]: Marktrücknahme

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December 11, 2010 – Die Firma Pfizer informiert über die Vertriebseinstellung von Sitaxentan [Thelin®]. Nach zwei Todesfällen infolge Leberversagens hat die Firma  das Arzneimittel Sitaxentan [Thelin®] nicht nur in Deutschland, sondern weltweit vom Markt genommen. Sitaxentan [Thelin®] war seit 2006 in Europa (in Deutschland seit 2007), Kanada und Australien zur oralen Therapie der pulmonalen arteriellen Hypertonie (PAH) im WHO/NYHA Stadium III zugelassen. Im Zuge dieser Massnahme sollen auch alle klinischen Studien abgebrochen werden.

Sitaxentan [Thelin®] gehört zur Gruppe der Endothelin-Rezeptorantagonisten. Ziel der Behandlung war es, die hämodynamischen Symptome der Erkrankung und die körperliche Belastbarkeit der Patienten zu verbessern. Derzeit werden in Deutschland ungefähr 600 Patienten mit diesem Arzneimittel behandelt.

Bereits in der klinischen Entwicklungsphase des Arzneimittels Sitaxentan [Thelin®] war in den klinischen Studien bei einigen Patienten ein Anstieg der Leberenzymwerte aufgefallen. Bei Patienten mit bekannter Leberschädigung (Child-Pugh Class A-C) war das Arzneimittel deshalb kontraindiziert. Dies hat aber offenbar nicht verhindert, dass es als Folge sogennanter idiosynkratischer Reaktion (welche heute noch kaum vorhersehbar sind) zu vereinzelten Todesfällen bei Patienten kam, welche mit Sitaxentan [Thelin®] behandelt wurden.

Patienten sollten die Einnahme von Sitaxentan [Thelin®] nicht ohne Rücksprache mit ihrem behandelnden Arzt beenden.

Patienten wird vielmehr empfohlen ihren Arzt aufzusuchen, um auf eine geeignete alternative Therapie umgestellt zu werden. Da mit Prostacyclin-Analoga, Bosentan, Sildenafil, und Tadalafil weitere pharmakologisch active Wirkstoffe zur Behandlung der PAH zur Verfügung stehen (Grafik (klicken Sie in das Bild zur Vergrösserung)), dürfte die Rücknahme von Sitaxentan [Thelin®] keine therapeutische Lücke aufreißen.

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About the Author
Joseph Gut - thasso Professor in Pharmakologie und Toxikologie. Experte in theragenomischer und personalisierter Medizin und individualisierter Arzneimittelsicherheit. Experte in Pharmako- und Toxiko-Genetik. Experte in der klinischen Sicherheit von Arzneimitteln, Chemikalien, Umweltschadstoffen und Nahrungsinhaltsstoffen.

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