Safety Alerts & Recalls

What does this mean?

Varenicline is an effective smoking cessation aid. The possible risks of serious adverse events occurring while using Varenicline should always be weighed against the significant health benefits of quitting smoking. The health benefits of quitting smoking include a reduction in the chance of developing lung disease, heart disease, or cancer.

It is not unusual to have symptoms such as irritability, feeling anxious, depressed mood and trouble sleeping when you are withdrawing from nicotine, whether you are taking smoking cessation drugs like Varenicline or not. With that said, if you are taking Varenicline you should be aware that Varenicline may cause changes in mood and behavior and contact your health care provider immediately if you experience agitation, depressed mood, and any changes in behavior that are not typical of nicotine withdrawal, or if you experience suicidal thoughts or behavior. You may also wish to alert your family members, friends, or caregivers about the potential for changes in mood or behavior with Varenicline and instruct them to contact your health care provider if they observe these changes in you.

If you would like to know more about the risks and benefits of Varenicline, please talk to your doctor about your concerns.

New Boxed Warning For Chantix (Varenicline)

The FDA announced that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs varenicline (marketed as Chantix) and bupropion (marketed as Zyban, Wellbutrin, and generics). The warning will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts and behavior when taking these drugs. The FDA is also requiring the manufacturers of Chantix to update the Medication Guide to highlight these risks.

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Source: FDA
Publication Date: 2009-07-01
Last Updated: 2009-12-05

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