Pfizer aktualisiert Champix®-Warnung in den USA

Pfizer hat in den USA die Warnhinweise für die Raucherentwöhungspille Chantix® (in Europa Champix®) ergänzt.
All patients being treated with CHANTIX should be observed for neuropsychiatric symptoms including changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior. These symptoms, as well as worsening of pre-existing psychiatric illness, have been reported in patients attempting to quit smoking while taking CHANTIX in the post-marketing experience. Patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder did not participate in the pre-marketing studies of CHANTIX and the safety and efficacy of CHANTIX in such patients has not been established. Patients attempting to quit smoking with CHANTIX and their families and caregivers should be alerted about the need to monitor for these symptoms and to report such symptoms immediately to the patient’s healthcare provider.

Es braucht nicht erwähnt zu werden, dass dies auf Druck der Öffentlichkeit und der Zulassungsbehörde FDA geschah.
 
[Champix]
Autor: strappato   2008-01-18   Link   (0 Kommentare)  Ihr Kommentar  








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