Drug Notebook

FDA Alerts

Special Alerts:

[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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What is the most important information I should know about varenicline?

Before using varenicline, tell your doctor if you have kidney disease, or a history of mental illness.

Use this medication exactly as it was prescribed for you. Do not use it in larger amounts or for longer than recommended by your doctor. Follow the directions on your prescription label.

Varenicline can cause drowsiness, which may impair your thinking or reactions. You may also have mood or behavior changes when you quit smoking. Until you know how varenicline and the smoking cessation process is going to affect you, Be careful if you drive or do anything that requires you to be cautious and alert. Stop using this medication and call your doctor at once if you have any mood or behavior changes, or if you feel agitated, depressed, or have thoughts about suicide or hurting yourself.

Less serious side effects are more likely, and you may have none at all. Varenicline can cause persistent nausea for up to several months. Talk to your doctor about any side effect that seems unusual or is especially bothersome.

If you miss a dose, use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

There may be other drugs that can interact with varenicline. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

What is varenicline?

Varenicline is a smoking cessation medicine. It is used together with behavior modification and counseling support to help you stop smoking.

Varenicline may also be used for other purposes not listed in this medication guide.

What should I discuss with my health care provider before taking varenicline?

Before using varenicline, tell your doctor if you have kidney disease, or a history of mental illness. FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether varenicline passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medicine to anyone younger than 18 years old.

How should I take varenicline?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

To improve your chances for successful smoking cessation, set a date to quit smoking. Start taking varenicline one week before your planned quit date.

When you first start taking varenicline, you will take a low dose and then gradually increase your dose over the first several days of treatment. Follow your doctor's instructions. Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Take this medicine with a full glass of water. Take the medicine after eating.

In most cases, varenicline treatment lasts for 12 weeks. Your doctor may recommend a second 12-week course of varenicline to improve the chance that you will quit smoking long-term.

It is important to take varenicline regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

To be sure this medication is not causing harmful effects, your kidney function may need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.

Store varenicline at room temperature away from moisture and heat.
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