FDA is issuing this public health advisory to alert patients, caregivers, and healthcare professionals to important changes to Chantix prescribing information. Chantix is a medicine used to help patients stop smoking.
At the request of FDA, Pfizer, the manufacturer of Chantix, has updated the Chantix prescribing information to include warnings about the possibility of severe changes in mood and behavior in patients taking Chantix. FDA is highlighting the following related important safety information on Chantix:
FDA first informed the public about the possibility of severe changes in mood and behavior in the November 20, 2007 FDA Early Communication About an Ongoing Safety Review. At that time, information about severe changes in mood and behavior in patients taking Chantix was added to the Chantix label with an explanation that the link between Chantix and these symptoms was unclear. As FDA’s review of the data has progressed it has become increasingly likely that the severe changes in mood and behavior may be related to Chantix. As a result, FDA worked with Pfizer, the manufacturer of Chantix, to add warnings to the Chantix label about the possibility of severe changes in mood and behavior so healthcare professionals and patients can be more alert to this information. In addition, FDA is working with Pfizer to finalize a Medication Guide for patients.
FDA will update the public about any new information from FDA’s continuing review of the data or new information that it receives on Chantix and severe changes in mood and behavior. FDA may consider additional changes to the Chantix prescribing information as the data review and conclusions warrant.
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