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Chantix
(varenicline)

Important
Chantix FDA Boxed Warning

Please note that it is important not to accept anyone's attempt to downplay this warning.  The FDA does not lightly issue a "boxed warning", the highest level caution given by that organization.  Read this carefully so you can decide for yourself if the the benefits of taking this drug or allowing it to be given to your child are worth these risks. 

Some people have had changes in behavior, hostility, agitation, depressed mood, and suicidal thoughts (thinking about harming or killing oneself or planning or trying to do so) while taking varenicline. The role of varenicline in causing these mood changes is unclear since people who quit smoking with or without medication may experience changes in their mental health due to nicotine withdrawal. However, some of these symptoms occurred in people who were taking varenicline and continued to smoke. Some people had these symptoms when they began taking varenicline, and others developed them after several weeks of treatment or after stopping varenicline.

These symptoms have occurred in people without a history of mental illness and have worsened in people who already had a mental illness. Tell your doctor if you have or have ever had depression, bipolar disorder (mood that changes from depressed to abnormally excited), schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions), or other mental illnesses.

If you experience any of the following symptoms, stop taking varenicline and call your doctor immediately: suicidal thoughts or actions; new or worsening depression, anxiety, or panic attacks; agitation; restlessness; angry or violent behavior; acting dangerously; mania (frenzied, abnormally excited or irritated mood); abnormal thoughts or sensations; hallucinations (seeing things or hearing voices that do not exist); feeling that people are against you; feeling confused; or any other sudden or unusual changes in behavior. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own. Your doctor will monitor you closely until your symptoms get better.
 
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with varenicline and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions.

You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088569.pdf) or the manufacturer's website to obtain the Medication Guide.
 
Talk to your doctor about the risks and benefits of taking varenicline.

 

 

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