CHANTIX (Varenicline) U.S. Label Update!
Thursday, January 12, 2017
Posted by: Natalia Gromov
The U.S. Food and Drug Administration (FDA) approved updates to the CHANTIX labeling, including removal of the boxed warning regarding serious neuropsychiatric (NPS) events. The removal of the boxed warning is based on the outcomes of EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study), the largest smoking cessation clinical trial in patients without and with a history of psychiatric disorder, and is consistent with the recent recommendation of the FDA Psychopharmacologic Drugs and Drug Safety and Risk Management Advisory Committees. Additional labeling revisions based on EAGLES include updates to the corresponding warning regarding NPS safety and the addition of clinical data on the safety and efficacy of CHANTIX.
Postmarketing reports of serious or clinically significant neuropsychiatric adverse events have been reported in patients treated with CHANTIX. These included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Observe patients attempting to quit smoking with CHANTIX for the occurrence of such symptoms and instruct them to discontinue CHANTIX and contact a healthcare provider if they experience such adverse events. I have included a link to the updated full Prescribing Information for CHANTIX (full Prescribing Information).
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