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Drug Notebook

FDA Alerts

Special Alerts:

[UPDATE 05/16/2008] FDA informed healthcare professionals and patients that as the Agency’s review of varenicline (Chantix) safety data has progressed, it appears increasingly likely that there is an association between varenicline and serious neuropsychiatric symptoms. Prescribing information for varenicline was revised to include this safety information in the WARNINGS and PRECAUTIONS sections of the label, and a Medication Guide for patients is also available. If patients, their families, or caregivers notice agitation, depressed mood, or changes in behavior that are not typical for the patient or if the patient has suicidal thoughts or actions, the patient should stop taking varenicline and contact their healthcare professional. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Chantix, http://www.fda.gov/cder/foi/label/2008/021928s008lbl.pdf, http://www.fda.gov/cder/drug/infopage/varenicline/default.htm, http://www.fda.gov/cder/Offices/ODS/MG/ChantixMG.pdf, http://www.fda.gov/cder/drug/InfoSheets/HCP/vareniclineHCP.htm, http://www.fda.gov/cder/drug/early_comm/varenicline.htm, http://www.fda.gov/medwatch/safety/2007/Chantix_PI.pdf.

[Posted 02/01/2008] FDA informed healthcare professionals and consumers of important revisions to the WARNINGS and PRECAUTIONS sections of the prescribing information for varenicline tartrate (Chantix) regarding serious neuropsychiatric symptoms experienced in patients taking varenicline tartrate. 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 varenicline tartrate who experienced serious neuropsychiatric symptoms and events had not yet discontinued smoking. In most cases, neuropsychiatric symptoms developed during varenicline tartrate treatment, but in others, symptoms developed following withdrawal of varenicline tartrate therapy. See the FDA Information for Healthcare Professionals Sheet for recommendations and considerations for healthcare professionals on using varenicline tartrate therapy for patients. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Varenicline, http://www.fda.gov/cder/drug/advisory/varenicline.htm, http://www.fda.gov/cder/foi/label/2008/021928s007lbl.pdf and http://www.fda.gov/cder/drug/InfoSheets/HCP/vareniclineHCP.htm.

[Posted 11/20/2007] FDA informed healthcare professionals of reports of suicidal thoughts and aggressive and erratic behavior in patient who have taken varenicline (Chantix), a smoking cessation product. There are also reports of patients experiencing drowsiness that affected their ability to drive or operate machinery. FDA is currently reviewing these cases, along with other recent reports. A preliminary assessment reveals that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating varenicline treatment. The role of varenicline in these cases is not clear because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. However, not all patients described in the cases had preexisting psychiatric illness and not all had discontinued smoking.

Healthcare professionals should monitor patients taking varenicline for behavior and mood changes. Patients taking this product should report behavior or mood changes to their doctor and use caution when driving or operating machinery until they know how quitting smoking with varenicline may affect them. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Chantix and http://www.fda.gov/cder/drug/early_comm/varenicline.htm.

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varenicline
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(var EN i kleen)

What is this medicine?

VARENICLINE (var EN i kleen) is used to help people quit smoking. It can reduce the symptoms caused by stopping smoking. It is used with a patient support program recommended by your physician.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

How should I use this medicine?

You should set a date to stop smoking and tell your doctor. Start this medicine one week before the quit date. Stick to your plan; ask about support groups or other ways to help you remain a 'quitter'.

Take this medicine by mouth after eating. Take with a full glass of water. Follow the directions on the prescription label. Take your doses at regular intervals. Do not take your medicine more often than directed.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular check ups. Ask for ongoing advice and encouragement from your doctor or healthcare professional, friends, and family to help you quit. If you smoke while on this medication, quit again

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

The use of this medicine may increase the chance of suicidal thoughts or actions. Pay special attention to how you are responding while on this medicine. Any worsening of mood, or thoughts of suicide or dying should be reported to your health care professional right away.

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