Serious neuropsychiatric symptoms experienced in patients taking Chantix™

On February 1, 2008, The U.S Food and Drug Administration (FDA), the equivalent of the Saudi Food and Drug Authority (SFDA), has issued an alert to highlight important revisions to the warnings and precautions sections of the full prescribing information for Chantix regarding serious neuropsychiatric symptoms experienced in patients taking Chantix.

These symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide. While some patients may have experienced these types of symptoms and events as a result of nicotine withdrawal, some patients taking Chantix who experienced serious neuropsychiatric symptoms and events had not yet discontinued smoking. CHANTIX™ tablets contain the active ingredient, Varenicline . It is indicated as an aid to smoking cessation treatment.

CHANTIX™ is supplied for oral administration in two strengths a 0.5 mg and 1 mg capsule.

Actions that Healthcare professionals should follow:

• Healthcare providers should monitor all patients taking Chantix for symptoms of serious neuropsychiatric symptoms.
• Patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder, may experience worsening of their pre-existing psychiatric illness while taking Chantix. Patients with serious psychiatric illness did not participate in the pre-marketing studies of Chantix. The safety and efficacy of Chantix in these patients has not been established.
• While Chantix has demonstrated clear evidence of efficacy, it is important to consider these safety concerns and alert patients about these risks.

Actions that Public should follow:

• Tell the doctor about any history of psychiatric illness prior to starting Chantix.
• Be alert to changes in mood and behavior. Symptoms include strange thoughts or behaviors, depressed mood, and thinking about or attempting suicide.
• Immediately report changes in mood and behavior to the doctor.
• Vivid, unusual, or strange dreams may occur while taking Chantix.

Report Adverse Drug Reactions to the SFDA: 
The public and health professionals are encouraged to report adverse drug reactions to the National Pharmacovigilance center on the internet at: